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Trial design
RECRUITMENT
This study was a prospective, single-centre, single-arm trial and investigated facial expressions before (T0) and 4 months after orthognathic surgery (T1). It was approved by the institutional ethics committee (application number 13/2/19) in accordance with the Declaration of Helsinki. All participants gave written informed consent to take part in the study. The trial was registered before recruitment started (DRKS00017206). No changes occurred after trial commencement.
PMC10560183
Participants, eligibility criteria, and settings
malocclusion
Patients seeking orthodontic-surgical treatment with an orthodontics first approach at the Department of Orthodontics, University Medical Center Goettingen, Germany, were enrolled consecutively. The eligibility criteria for participants were adults over 18 years old, orthodontic therapy with fixed appliance, pronounced malocclusion (skeletal class II: Wits appraisal > 2 mm; skeletal class III: Wits-appraisal <  − 2 mm), and indication for combined orthodontic-surgical treatment (classified as grade 4 or higher using the index of orthognathic functional treatment need [
PMC10560183
Sample size
RECRUITMENT
As this trial is an early clinical trial with the aim to implement the novel method of 4D videostereophotogrammetry, sample size calculation was not based on a priori-hypothesis testing. Based on previous treatment numbers, in total 45 patients (1 skeletal class I, 21 skeletal class II, 23 skeletal class III) were operated in an interval similar to the scheduled recruitment phase of this study; a feasible sample size of 20 patients was planned for recruitment. The final sample size was 26 patients (13 skeletal class II, 13 skeletal class III) and a complete case analysis was performed.
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Intervention
All patients underwent virtually planned, splint-based orthognathic surgery performed by an interdisciplinary team of orthodontists and maxillofacial surgeons as described previously [
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Blinding
Blinding was not applicable.
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Outcome—facial expressions
Facial expressions were recorded as 3D videos using non-invasive 4D stereophotogrammetry with nine cameras (6 greyscaled and 3 coloured) and 60 frames per seconds (see Fig. Motion capture system recording facial expressions as 3D videos using non-invasive 4D stereophotogrammetry with nine cameras (6 greyscaled and 3 coloured) from three directions (DI4D PRO System, Dimensional Imaging Ltd., Glasgow, UK). [All video captures and post-processing were performed by the same trained investigator (J.H.). The 3D videos were cut to analyse the movements from the last frame in rest position (= start frame) to the first frame with the facial expression at its maximum extent (= end frame) (DI4D Setup, Dimensional Imaging Ltd., Glasgow, UK). To track the facial movement, a dummy mesh was applied to the individual patient morphology in the first frame of each video (see Fig. Information captured by videostereophotogrammetry in the first frame. Left side: video data containing the colour and texture of the subject. Right side: dummy mesh applied to the individual patient morphology to track the facial movementSequence of exemplary 3D images recorded by the 4D system. The patient-specific mesh applied in the first frame was automatically tracked throughout the sequence of 3D images and manually corrected if necessaryTwo regions of interest were determined (see Fig. the lower face: the area of the lower face limited by a plane through the landmark subnasale parallel to Frankfort Horizontal containing the same automatically selected 559 points for each participant, andthe landmarks undergoing the biggest change during facial expression: cheilion left and right for maximum smile, and labrale superius and inferius for lip purse.Data analysis in Python. Left side: selection of the region of interest “lower face” limited by a plane through subnasale (green points). The region of interest was determined in the first patient analysed and automatically transferred to each subsequent patient. Right side: the landmarks undergoing the biggest change during facial expression (green points) were determined individually for each captureFor each facial expression, four parameters were calculated to objectively evaluate the movement (see Table Parameters calculated to objectively evaluate the facial expressionsMagnitude of facial expression in the most moving area of the lipsFor maximum smile: For lip purse: Differences in facial expression between the two most moving areas of the lipsFor maximum smile: For lip purse: d, Euclidian distanceExemplary illustration of the measurement “magnitude” for the facial expression maximum smile at the landmark cheilion right. The image at rest position (yellow) and the image at the maximum extent of the movement (transparent) are superimposed and the Euclidian distance between the landmark cheilion right at rest position and at maximum smile is measured (orange arrow)
PMC10560183
Method error analysis
To assess the reliability of the 4D tracking of facial expressions, the same investigator repeated the application of the dummy mesh to the individual patients’ morphology in ten cases. Additionally, a second examiner performed the same task one time. Agreement was excellent for the magnitude of facial expression (ICC = 0.982; 95% CI [0.933, 0.995]) and good to excellent for the shape change in the region of interest lower face (ICC = 0.947; 95% CI [0.814, 0.986]).
PMC10560183
Statistical analysis
The analysis was performed using linear mixed-effects models with factors time, skeletal class, and their interaction. A sensitivity analysis using a paired Wilcoxon-signed rank test was performed. Estimated marginal means are reported with 95% confidence interval and compared between time and skeletal class [
PMC10560183
Results
PMC10560183
4D motion capture
4D motion capture was feasible using stereophotogrammetry and resulted in 3D videos with a rate of 60 frames per second. Colour and texture were recorded as well as surface geometry (see Supplementary Information
PMC10560183
Facial expressions
For maximum smile the mean magnitude of movement increased significantly from T0 until T1 by 2 mm. At T1, smiling became more asymmetric. No differences in shape change or time was observed. The mean magnitude of lip purse decreased from T0 until T1 by 1 mm. Shape change, symmetry, and time for the facial expression did not differ significantly between T0 and T1 (Table Means and 95% CI of the parameters analysing facial expressions pre- (T0) and post-surgical (T1) in all patients (The post-surgical increase in the magnitude of maximum smile and the decrease in the magnitude of lip purse were observed in all but 5 and 6 patients, respectively.Subgroup analysis showed that these results apply to patients with skeletal classes II and III (Table Means and 95% CI in the changes of the facial expressions (T1–T0) compared between patients with skeletal class II (Skeletal class IIMaximum smileSkeletal class IIIMaximum smileSkeletal class IILip purseSkeletal class IIILip purseThe results of the multivariate linear model with the difference in the magnitude of maximum smile as dependent variable showed that the pre- and postsurgical differences in the magnitude of smile cannot be explained by the surgical movements, the type of surgical intervention, or the skeletal class (Table Results of the multivariate linear model with the difference in the magnitude of maximum smile as dependent variable and the surgical movements, the type of surgical intervention, and the skeletal class as explaining variables. The difference in the magnitude of maximum smile cannot be explained by the explaining variablesResults of the multivariate linear model with the difference in the magnitude of lip purse as dependent variable and the surgical movements, the type of surgical intervention, and the skeletal class as explaining variables. The difference in the magnitude of lip purse cannot be explained by the explaining variables
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Harms
No harms were observed.
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Discussion
PMC10560183
Main findings in context of the existing evidence—method
The main strength of this study was the implementation of modern videostereophotogrammetry in orthodontics and its use to capture facial movements in 4D. In contrast to previous attempts analysing facial expressions using markers on the patients’ face [A current disadvantage of videostereophotogrammetry is that the necessary cameras, lightning systems, computers, and software are expensive and bulky. However, portable low-cost 4D cameras already exist and make their way in clinical application [
PMC10560183
Main findings in context of the existing evidence—results
The main finding was that orthodontic-surgical treatment increases the magnitude of the facial expression maximum smile by approximately 13% (= 2 mm), while it decreases that of the facial expression lip purse by approximately 11% (= 1 mm). The parameters shape change, time, and symmetry of the movement demonstrated no relevant changes from T0 to T1. The novelty of videostereophotogrammetry makes it difficult to compare these results with existing evidence. There are first attempts to integrate the dynamics of facial motion in orthodontic-surgical research [Furthermore, the question arises whether 1 or 2 mm (11–13%) changes in the magnitude of the facial expressions, like found in the present study, are clinically relevant. With regard to social interaction the interpretation of the data gets even more complex as culture and gender shapes our expectations about the intensity of facial expressions in the sense of emotions [
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Limitations
The participants of the study were not operated on by the same surgeon, but all surgeries were performed at a single centre following the same stringent protocol. Since a multi-centre study revealed that even different surgeons at different centres obtain similar accuracy when following a virtual treatment plan [It is possible that the patients’ compliance, the intensity of care provided by the orthodontic-surgical treatment team, and subsequently the speed of post-surgical recovery were influenced by the fact that the patients were part of a clinical trial. Because of that Hawthorne effect, the participants in the present study might show increased facial expressiveness.The observed changes in maximum smile and lip purse were rather small. Due to the novelty of the method, there are no reference values which indicate what amount of change should be considered clinical relevant and what extent of change is detected by orthodontists, surgeons, laypersons, or the patients themselves. Future studies are needed to generate norm values.
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Generalisability
The results of this trial were from a single specialist clinic in Germany, which might reduce the applicability to other clinical settings. However, the eligibility criteria include most patients undergoing orthodontic-surgical treatment and the followed surgery protocol is widely used and well established.This study did not have the purpose to investigate gender differences in orthodontic surgical treatment and gender distribution within the study sample was not equal. This reflects the real clinical situation since women are more likely to accept surgical intervention than men [
PMC10560183
Further research
swelling, orthodontic, malocclusions
RECRUITMENT
The focus of this study was the integration of videostereophotogrammetry in orthodontic-surgical treatment. To fully understand the effect of orthodontic-surgical treatment on facial expressions, long-term observations and extended study periods are needed. Baseline assessment was performed after orthodontic decompensation with fixed appliances in situ, which might have affected facial movements. Future studies should consider recruitment of patients with severe malocclusions prior orthodontic treatment. The follow-up of 4 months post-surgical in this study was chosen because the swelling has usually subsided by that time [
PMC10560183
Conclusions
The present study implemented the novel approach of 4D motion capture using videostereophotogrammetry in orthodontic research. Within the limitations of this clinical trial, the following conclusion can be made:Implementation of videostereophotogrammetry in orthodontic-surgical treatment is feasible and allows the evaluation of facial movements.The magnitude of the expression maximum smile increases while that of lip purse decreases.This change in facial movements following orthodontic-surgical treatment was observed independently of skeletal classes, surgical movements, or type of surgical intervention in this preliminary study.
PMC10560183
Author contributions
A.Q., M.S., H.S. and P.M.M. contributed to study conception and design. A.Q., J.H. and P.K. recruited participants and collected the data. J.H. performed the 4D tracking. J.M. wrote the code for data analysis. A.Q., T.A. and C.D. analyzed and interpreted the data. A.Q. and P.M.M. drafted the manuscript. All authors critically revised the manuscript and gave final approval.
PMC10560183
Funding
Open Access funding enabled and organized by Projekt DEAL. This work was supported by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation)—427616114—and by the Deutsche Gesellschaft für Kieferorthopädie (DGKFO, German Orthodontic Society).
PMC10560183
Data Availability
The data that support the findings of this study are not openly available due to reasons of sensitivity and are available from the corresponding author upon reasonable request.
PMC10560183
Declarations
PMC10560183
Competing interests
The authors declare no competing interests.
PMC10560183
Ethical approval
This study was approved by the institutional ethics committee (application number 13/2/19) in accordance with the Declaration of Helsinki.
PMC10560183
Conflict of interest
The authors declare no competing interests.
PMC10560183
References
PMC10560183
Participants
Cushing’s or Addison, eating disorder
DISEASE
In this study, non-athletes were defined as individuals who did not currently engage in any form of sport at any level of competition (e.g., recreational or intramural sports). Varsity athletes were defined as members of a university competitive club or varsity team (competing at the provincial or national level). Athletes were not eligible to participate if they competed in aesthetic (i.e., the outcome of the competition is directly related to the competitors’ physical appearance or body positioning/posture, such as cheerleading, figure skating, and gymnastics) or weight-dependent sports (i.e., those in which athletes compete within weight classes or categories, such as powerlifting, rowing, boxing, and wrestling) due to body image differences that may occur in athletes from these types of sports (Participants were not eligible to participate in the current study if they smoked, had a history/diagnosis of a clinical eating disorder, or if they had been diagnosed with a disease affecting cortisol, such as Cushing’s or Addison’s disease (An a priori power analysis was performed to determine the required sample size needed for the proposed analyses. Based on medium to large effect sizes reported in previous studies utilizing similar procedures (A total of 112 men between the ages of 18 and 28 who were either non-athletes (
PMC9947689
Measures
PMC9947689
Demographic Questionnaire
hepatitis B
HEPATITIS B, STRESSFUL EVENTS
The demographic questionnaire screened participants for factors that could influence cortisol (e.g., antidepressant medication, hepatitis B) and was used to collect self-reported information, such as age, major, year of study, ethnicity, sexual orientation, and varsity/club sport (if applicable). Participants were screened for stressful events on the day of testing and to ensure that they followed the study requirements before arriving at the lab (i.e., refraining from eating, drinking, and exercising within 1 hr prior to the start of the session), as well as waking time that day.
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Trait Questionnaires
The International Physical Activity Questionnaire-Short (The Sociocultural Attitudes Towards Appearance Questionnaire-4 (SATAQ-4; The Male Body Attitude Scale (MBAS;
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State Body Shame Questionnaire
The shame subscale of the Weight and Body-Related Shame and Guilt Scale (WBRSG-BS;
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Manipulation Checks
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Previous Anthropometric Experience
Participants were asked if they had any of the anthropometric or strength measurements taken previously. This measure was used to see if previously having undergone these measures could potentially explain any blunted responses observed.
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Perceptions of Confederates
Participants in the high-threat condition were asked to rate how attractive they thought the female research confederate was and how similar the male confederate was to their muscular ideal. Participants rated the female confederate ranging from 0 =
PMC9947689
Procedure
BROCK, RECRUITMENT
Upon receiving ethics clearance from Brock University’s research ethics board (REB# 17-083), participants were recruited via classroom and sport team meeting announcements, and through a participant recruitment site run by the university’s psychology department. Prospective participants were told the study investigated mental health, hormones, and physical characteristics in university male athletes and non-athletes to obtain authentic responses, obscured from the anticipation of the SET (All testing took place between 2 and 7 pm, when circulating cortisol is at its lowest and most stable for the day (At the second session, participants underwent either the high or low SET condition. Upon arrival, participants were asked to change into their shorts using the private washrooms around the corner from the lab. Upon returning, participants were seated and provided a baseline saliva sample. Next, participants completed a baseline measure of state body shame. This took approximately 5 min to complete. Once completed, participants provided a second saliva sample (pre-threat). Following, participants were briefed on the series of physical measurements (chest, waist, and flexed biceps circumference, height, weight, percent body fat via skinfold measurements) and test of strength (handgrip) they would be undergoing. They then underwent their condition consistent with their group assignment (see below for descriptions). Immediately following the anthropometric and strength measures, a third saliva sample (post-threat), followed by the third state body shame questionnaire, was completed. Following a 10-min wait period, where the participants were instructed not to talk, sleep, or use any electronics, participants provided a fourth saliva sample (intermediate timepoint) followed by the state body shame questionnaire. This saliva sample was approximately 30-min post-stressor onset, which has been identified as the optimal time to capture peak cortisol responses to psychosocial stressors (
PMC9947689
High-Threat Condition
The principal researcher (male), a research assistant (female), and two confederates were present in the high-threat condition only. The male confederate (described as a second participant) represented the male ideal (muscular build, well-defined abdominals, strong arms, and a “V” shaped figure; Once changed into their shorts and t-shirt, participants were directed to their seat, which was situated immediately to the right of the male confederate. This seating was purposeful as it forced the participant to either look at the two mirrored walls in front of them and to their right, or the male confederate to their left, during the entirety of the testing session. Following the second saliva sample (pre-threat), the female confederate and a research assistant brought out the testing equipment (i.e., skin calipers and measuring tape, handgrip dynamometer, scale, and stadiometer) and set up the video camera. The principal researcher then explained all the testing procedures. Participants were told that they would undergo several physical and strength assessments to indicate overall strength and muscularity, with their shirts off for accuracy. They were told that the video camera was there to ensure the measurements were taken properly and accurately although the camera was not actually recording. Standardized laboratory procedures for all physical and strength measures were used.The male confederate was always tested first, directly in front of the actual participant. All measurements were taken and read out loud by the female confederate, such that everyone in the room could hear, and were recorded by the principal researcher. Once all the measurements were completed, participants were told that the research assistant was going next door to calculate percent body fat and determine norms for the first participant’s (male confederate’s) values. Upon returning to the room (in approximately 2–3 min) the research assistant passed the “results” to the female confederate, who then read the male confederate’s “results” out loud so all could hear. Values indicated that the male confederate tested in the healthiest range for percent body fat and in the upper range for strength and arm, chest, and waist circumferences, similar to what is typically seen for international level athletes. Following, the participant underwent the same anthropometric measurements in the exact same order. The female confederate read all measurements out loud for everyone in the room to hear. However, upon completion, the participant was told that to save time the testing would proceed, and all measurements would be made available to them at the end of the testing session. Following the fifth saliva sample (recovery) participants completed a questionnaire assessing how similar the male confederate was to their body ideal, and how attractive they found the female confederate.
PMC9947689
Low-Threat Condition
Testing in the low-threat condition was performed in the same laboratory as the high-threat condition; however, all of the testing was performed away from the mirrored walls. Only the principal researcher and one research assistant were present. Following screening, participants were asked to change into their shorts and t-shirt. The anthropometric tests were the same as those in the high-threat condition but were recorded quietly without any feedback given to the participants and with no video camera present. In this condition, the participant waited quietly for 10 min before completing their anthropometric measurements to account for the time of the confederate’s measurements in the high-threat condition. Due to the removal of the social-evaluative aspects of the design (i.e., mirrors, confederates, additional researchers, video camera, and shirtless anthropometrics with feedback), the low-threat condition acted as the control group.
PMC9947689
Salivary Collection Procedures and Cortisol Assay Determinants
Saliva was collected using Salivettes (Sarstedt). Participants were instructed to accumulate as much saliva in their mouths as possible. They were then told to remove the cap off the plastic tube and place the swab in their mouth without using their hands, hold it in their mouth for 1 min, gently moving saliva toward it without chewing or swallowing it. After 1 min, participants were told to guide the swab from their mouth back into the plastic tube without touching the edges of the container with their lips to avoid any potential cross-contamination of saliva samples. Immediately after testing, the Salivettes were centrifuged at 3,400 rpm at 1,100 × g using the Hamilton Bell V6500 Vanguard and stored in a freezer at −20°C (−4°F) until analysis.All enzyme immunoassays were carried out on NUNC Maxisorb plates. Cortisol antibodies (R4866) and matching horseradish peroxidase conjugate were obtained from C. Munro of the Clinical Endocrinology Laboratory, University of California, Davis. Steroid standards were taken from Steraloids, Inc. Newport, Rhode Island. Plates were first coated with 50 μL of antibody stock diluted at 1:8500 in a coating buffer (50 mmol/L bicarbonate buffer pH 9.6), then sealed and stored for 12–14 hr at 4°C. A 50 μL wash solution (0.15 mol/L NaCl solution containing 0.5 ml of Tween 20/L) was added to each well to rinse away unbound antibody. Next, a 50 μL phosphate buffer was added to each well. Plates were incubated at room temperature for 2 hr before standards, samples, or controls were added. Two quality control salivary samples, at 30% and 70% binding (the low and high ends of the sensitivity range of the standard curve), were prepared. A 50 μL cortisol horseradish peroxidase conjugate was added to each well, with a 50 μL of standard, sample, or control. Plates remained incubated for 1 hr after plate loading, then washed with 50 μL wash solution and 100 μL of a substrate solution of citrate buffer; H
PMC9947689
Results
Two univariate outliers for physical activity levels were identified, and these values were winsorized (
PMC9947689
Descriptive Statistics and Manipulation Checks
Athletes and non-athletes differed significantly on height (Athletes (Means and standard deviations for the dependent variables at each time point, by condition and athletic status, were calculated (
PMC9947689
State Body Shame
A three-way (athlete status, condition, and time) mixed RM ANOVA was produced. There was no significant three-way interaction (
PMC9947689
Salivary Cortisol
A three-way (athlete status, condition, and time) mixed RM ANCOVA was produced, with baseline salivary cortisol as the covariate. There was no significant three-way interaction (
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Discussion
The overall purpose of the current study was to examine psychobiological responses to (i.e., state body shame and salivary cortisol), and recovery from, a social-evaluative body image threat in young men and whether those responses differed by athlete status. It was first hypothesized there would be significant increases in salivary cortisol (pre- to intermediate-timepoint) and state body shame (pre- to post-threat) in the high-threat condition only, with a subsequent return to baseline values 50-min post-stressor onset, with increases greater in the non-athletes compared with the athletes in the high SET condition. Finally, it was hypothesized that there would be no significant changes in non-athletes’ and athletes’ psychobiological responses in the low SET condition. These hypotheses were partially supported; participants in the high-threat condition exhibited significant increases in state body shame and salivary cortisol immediately following the threat, with a subsequent return to baseline values for state body shame; however, contrary to the hypotheses, there were no significant differences between the non-athletes’ and athletes’ responses.
PMC9947689
Athletes Versus Non-Athletes
Contrary to both body image (This is the first study to examine body shame responses in athletes versus non-athletes (Second, the varsity athletes in the current study were at a lower competitive level (e.g., interuniversity) compared with previous studies that examined more elite level athletes (e.g., national endurance athletes), thus potentially reporting greater psychological responses. Finally, the non-athletes in the current study reported high levels of physical activity and met recommended weekly physical activity guidelines for adults (These studies together help to highlight the complicated relationship that exists between athletes and their body image and supports the existing evidence suggesting that athletes experience body image concerns and respond to social evaluation of the physique (
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Implications
The current study provides a number of important implications for future body image and SSPT research. First, it offers further support for the idea that male athletes and non-athletes experience meaningful and impactful body image concerns comparable to women (Within the context of SSPT, this study provides further evidence for the integration of SSPT within a body image context by demonstrating the impact of body image SETs on non-athletes’ and athletes’ psychobiological responses. Much of the SSPT literature has utilized performance-based SETs (i.e., speech tasks; The current study provides evidence of the physiological consequences of acute body image stressors involving social evaluation in male athletes. These social-evaluative body image threats, and subsequent physiological responses, may frequently occur within Western society as Western culture tends to place great importance and pressure on people and athletes to meet body image ideals (
PMC9947689
References
PMC9947689
Introduction
BDD, third-wave, depressive, psychiatric, BDD behaviors, Shame, binge eating disorder, depression, dysmorphic disorder
DISORDER
Shame is considered central in body dysmorphic disorder (BDD) and empirical accounts highlight the link between shame and BDD symptoms as well as common negative psychosocial effects of the disorder, yet there is a lack of interventions addressing shame in this context. In the past decade, Acceptance and commitment therapy (ACT) and interventions that foster self-compassion have shown promise for reducing the negative effects of shame in a range of clinical problems. The aim of the present study was to develop and evaluate an acceptance and compassion-based treatment specifically targeting shame in BDD. Using a randomized nonconcurrent multiple baseline design, the 12-session intervention, ACT with Compassion (ACTwC), was examined in a psychiatric outpatient sample of five adults diagnosed with BDD. The daily ratings showed marked reductions in BDD-behaviors and self-criticism at posttreatment for four of five participants, while three participants demonstrated decreases in body shame compared to baseline. Improvements were maintained at 6-months follow-up. The intervention also led to reliable long-term improvements in general shame, overall BDD-symptoms, depressive symptoms, and quality of life for four of five participants. All treatment responders showed significant gains in psychological flexibility and self-compassion. Participants reported high credibility and satisfaction with the treatment. These preliminary results suggest that ACTwC may be a promising approach to treating shame in BDD, worthy of further investigation.Body dysmorphic disorder (BDD), characterized by a preoccupation with a perceived flaw in appearance (One way to improve treatment outcomes for BDD may be to target shame, an emotion considered central in this disorder (Shame refers to the affective experience of perceiving the self as intrinsically flawed and socially undesirable (Accumulating research points to considerable negative effects of shame in BDD. Shame contributes significantly to increased overall BDD-symptoms and commonly co-occurring negative psychosocial consequences, such as limited functioning, hopelessness, depression, and suicidal thoughts (Even though research shows a link between shame and severe adverse outcomes in BDD, there are yet no evaluations of interventions specifically targeting shame in this disorder. One reason for this is perhaps that CBT, the most established psychological treatment method for BDD, is focused on treating maladaptive cognitions and diagnosis-specific symptoms, rather than shame. However, when treating people who are highly shame-prone and self-critical, theorists suggests that shame needs to be directly targeted in treatment (In the past decade, evidence has emerged supporting the use of interventions developed in more recent “third-wave therapies” building on the CBT tradition, for conditions where shame is a prominent feature. Treatment approaches such as Acceptance and commitment therapy (ACT) and Compassion focused therapy (CFT), have shown potential to reduce shame and associated problems in a range of clinical conditions; for example, binge eating disorder (ACT is proposed to be an effective approach for reducing negative effects of shame due to the treatment’s potential to decrease experiential avoidance and increase psychological flexibility, including weakening the influence of self-critical thoughts (Another promising approach for alleviating detrimental effects of shame and self-criticism is to build self-compassion (Based on advances in the research field on shame and previous research on BDD, we have developed a psychological treatment intervention targeting shame in BDD. The manualized treatment, ACT with Compassion (ACTwC) for BDD, integrates ACT with elements from CFT and knowledge on BDD. ACTwC for BDD, is designed to target shame and self-criticism and increase psychological flexibility and self-compassion with the overarching goal of increasing quality of life in patients suffering from BDD. An earlier version of this treatment that did not include elements focused on compassion and shame (ACT for BDD) was tested in a group therapy format with 21 patients with BDD (The purpose of the present study was to evaluate the effect and feasibility of a psychological treatment intervention directly targeting shame in BDD. In this early stage of evaluating a new treatment approach to BDD, our objectives were to investigate; (a) preliminary effectiveness and (b) patient’s acceptance of and satisfaction with the treatment. Using a multiple baseline design, the treatment’s effect on the primary outcomes of body shame, self-criticism, and BDD behaviors, was evaluated. Secondary outcomes were overall symptoms of BDD, depression, quality of life, self-compassion, and psychological flexibility. Treatment feasibility was evaluated by investigating patient’s perceived credibility and expectancy as well as satisfaction with the intervention. We aimed to evaluate the feasibility of the treatment in a real-world context and therefore chose to conduct the study in a psychiatric outpatient clinic.
PMC10150257
Method
PMC10150257
Study Design
SECONDARY
To investigate the effectiveness of the intervention for reducing body shame, self-criticism, and BDD-behaviors, a randomized, nonconcurrent, multiple baseline across participants design was used (Following enrollment, participants were randomized to baseline assessment phases of different lengths, between 2 and 6 weeks, using randomly drawn sealed envelopes. Participants completed daily self-report measures via a secure Internet-based platform throughout the baseline and subsequent 12-session treatment phase and at 6-months follow-ups. In addition to the daily measures, standardized outcome measures were used to evaluate the secondary outcomes at baseline, mid-treatment, posttreatment, and at 6-month follow-up.A second aim was to investigate feasibility of this new treatment approach to BDD. We assessed credibility of treatment and patient’s expectancy for improvement (after the third session) and satisfaction with the treatment (after treatment completion).Prior to data collection, the study was registered and approved by the regional ethics committee (Registration number 2018/2374-31).
PMC10150257
Primary outcomes
self-criticism
The primary outcome measure was the daily self-monitoring of BDD-related behaviors and the level of body shame and self-criticism experienced. Before baseline, the concepts of BDD-behaviors, shame, and self-criticism were explained and participants were shown how to fill out the daily assessment.
PMC10150257
Daily time spent on BDD-behaviors
BDD-related behaviors, avoidance behaviors
The daily record sheet asked participants to record the time spent on BDD-related behaviors, categorized in checking, comparing, camouflaging, and avoidance behaviors (e.g., “Number of minutes spent on camouflaging”). The sum of each participants’ daily BDD-behaviors is presented in the results section.
PMC10150257
Daily ratings of body shame and self-criticism
Along with the BDD-behaviors, participants were asked to rate their degree of (1) body shame (“On a 0–10 scale, where 0 = no shame at all, and 10 = the most shame ever, to what extent have you felt ashamed because of your appearance today?”) and (2) self-criticism (“On a 0–10 scale, where 0 = not self-critical at all, and 10 = the most self-critical ever, how self-critical have you been today?”).
PMC10150257
Secondary outcomes
PMC10150257
BDD symptoms
The Yale-Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS;
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General shame
The Internalized Shame Scale (ISS;
PMC10150257
Self-compassion and self-criticism
Self-compassion was measured with the 12-item Self-Compassion Scale-Short Form (SCS-SF;
PMC10150257
Depression
Depression, MADRS-S
The Montgomery-Åsberg Depression Rating Scale (MADRS-S;
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Quality of life
The Quality of Life Inventory (QOLI;
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Psychological flexibility
Dysmorphic Disorder
The Body Dysmorphic Disorder Acceptance and Action Questionnaire (BDD-AAQ) is an investigator created 12-item measure of willingness to accept undesirable thoughts and feelings associated with one’s appearance, while acting in a way that is congruent with values and goals. All items are reverse scored and are summed to produce a total score. Higher scores indicate greater psychological flexibility. The scale (included in
PMC10150257
Cognitive fusion
The Cognitive Fusion Questionnaire–7 (CFQ;
PMC10150257
Treatment credibility
Credibility/Expectancy Questionnaire (CEQ;
PMC10150257
Treatment satisfaction
Treatment satisfaction was assessed with Client Satisfaction Questionnaire (CSQ-8;
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Intervention
compassion-focused
The treatment, ACTwC, was designed to target shame and self-criticism and increase self-compassion, psychological flexibility, and quality of life in patients suffering from BDD. A manual to guide each treatment session was developed based on integrating research on BDD with theory and techniques from ACT and compassion-focused therapies (see The intervention consisted of 12 individual therapy sessions, around 60 minutes each; including psychoeducation on the treatment concepts (e.g., conceptualization of BDD from an ACT and compassion perspective); building skills in present-centered, nonjudgmental awareness, especially of one’s own suffering (e.g., through basic mindfulness training); experiential exercises (aiming at fostering self-compassionate self-talk, defusion, acceptance, and perspective taking abilities); training in acknowledging, eliciting, and regulating previously avoided emotions of shame (e.g., exposure to internalized shame through chair-work-techniques); practicing self-compassion in response to shame and self-criticism and promotion of value-guided actions in daily life.Treatment was delivered by three clinical psychologists with previous experience in treating BDD patients. The first author, with expertise in BDD treatment, developed the treatment manual in collaboration with experts in ACT, treated two of the patients and also supervised the other two therapists weekly. Before delivering treatment, the therapists received approximately 3 hours of training in the manual. All treatment sessions were audio-recorded for weekly supervision and therapist adherence to the treatment manual. Sessions were divided into 10 minute modules that were chosen randomly for adherence checks. Adherence to the session content and structure as well as therapist adherence to ACT and compassion principles were evaluated by the treatment developer using a predefined adherence manual (available on request). Adherence level was rated as either sufficient, or not sufficient. The majority of the modules (90%) was judged as having been conducted in a sufficient manner.
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Data Analysis
Data analyses were conducted according to established guidelines for single-case experimental designs, with visual inspection of plotted data as the primary method (For the standardized outcome measures, 95% confidence intervals (CIs) were calculated for each participant’s change scores to evaluate the reliability of the change from pre- to posttreatment and change from pretreatment to 6-month follow-up. For each outcome measure, a standard error of the difference (Sdiff) was calculated, following the method developed by The BDD-YBOCS scale was used to identify the number of participants who achieved Feasibility data from the standardized measures of credibility, expectancy, and satisfaction with treatment is presented in descriptive form.
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Results
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Shame
The daily records of body shame showed large fluctuations from day-to-day during all phases, including baseline phase (At intake, global shame measured by the ISS, was in the range of moderate to severe shame severity for all participants (
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Depression
depression
At pretreatment, all of the participants had scores on the MADRS-S indicating moderate to severe depression (
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Quality of Life
Before treatment, all participants reported low or extremely low quality of life, based on the QOLI (
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Process measures
See
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Self-Compassion
eating disorders
At intake, all participants had scores on the SCS-SF, measuring self-compassion, comparable or lower than previously published means for a clinical sample with eating disorders (
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Psychological Flexibility
All participants reported improvements in psychological flexibility measured by the BDD-AAQ, with gains ranging from 28% to 188% posttreatment. Cognitive fusion, measured by the CFQ-7, reliably decreased (with 41%–60%) for P1, P2, and P5 during treatment. For P4, scores were unchanged at posttreatment but had significantly improved at follow-up. On the contrary, P7 reported an increase in cognitive fusion posttreatment.
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Treatment Credibility and Acceptability
After psychoeducation phase, all participants rated ACTwC for BDD as credible (According to the CSQ-8, the four treatment responders were very satisfied with the treatment they received, whereas the non-responder reported he was indifferent or somewhat displeased. Furthermore, all treatment responders found treatment quality to be excellent, reported that it met almost all or most of their needs, that they learned a much better approach to their problems and that they would recommend ACTwC to a friend with similar problems. P7, who did not respond to the treatment, reported that treatment quality was ok but the treatment only met a few of his needs.
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Discussion
depressive, depression, psychiatric, self-criticism
SECONDARY, REMISSION
This study used a controlled multiple baseline design methodology to evaluate a 12-session acceptance and compassion-based intervention targeting shame in BDD. Our first aim, to investigate preliminary effectiveness of ACTwC for BDD, was supported. The intervention led to large improvements in BDD-behaviors and self-criticism for all but one participant, and reductions in body shame for three of five participants. The standardized outcome measures administered pre-, mid-, and posttreatment followed the same pattern as the daily measures with significant decreases for most participants in overall BDD-symptoms, self-criticism, and general shame at posttreatment. In addition, treatment led to large and reliable improvements in quality of life and depressive symptoms for all but one participant. Improvements were maintained at 6-months follow-up.The intervention’s effect on shame and self-criticism is worth reflecting on in some more detail. Overall, self-criticism decreased faster and more consistently than shame across most subjects. Body shame fluctuated from day-to-day throughout treatment and the standardized measures even showed some increases in general shame at midpoint. However, at follow-up the level of body shame had decreased compared to baseline for three participants and general shame had significantly improved for four of the participants compared to pretreatment. The slow and uneven gains in shame is consistent with previous findings by The temporary increases and slow gains in shame during treatment phase may be interpreted as an effect of a treatment focus on eliciting contact with previously avoided feelings of shame. The ability to acknowledge, accept, and regulate the experience of shame was promoted throughout treatment. In an ACT approach, fostering awareness and openness to undesirable thoughts and feelings (e.g., of shame), is key to reduce negative effects of inner experiences. In fact, the real goal in ACT is to promote psychological flexibility and value-guided action in the presence of painful emotions, rather than reducing emotions themselves. However, when psychological flexibility in response to difficult thoughts and feelings increases, usually the emotions are also perceived as less burdensome and tend to decrease, which may explain the long-term reductions in shame.Even though the treatment was designed to target shame, it also had a large effect on patient’s BDD-behaviors, providing some preliminary support for the proposition by Furthermore, the secondary outcomes showed large and reliable treatment effects on BDD-symptoms for most participants. At posttreatment, four of the five participants could be classified as treatment responders, reflecting clinically meaningful reduction on the BDD-YBOCS according to the predefined criterion, and as achieving symptom remission at follow up. The treatment response and symptom remission rates gained in this study is excellent compared to what is typically found in clinical trials of BDD. In comparison, a study by In addition, the four responders in the present study made large and reliable improvements in quality of life and depressive symptoms. They went from moderate-severe depression at pretreatment to mild or subclinical symptoms after treatment, and from low quality of life to levels comparable to non-clinical samples in previous studies (Congruent with expectations, the treatment also had a significant effect on the proposed treatment processes. Most participants demonstrated increases in psychological flexibility and self-compassion after treatment, suggesting that the intervention strengthened these abilities. Additional research is needed to evaluate the impact of these proposed treatment processes. Future studies should investigate the mediating or moderating potential of these processes on the effects of shame in BDD.The second objective of the present study was to evaluate the feasibility of this new treatment approach to BDD. Most participants reported high levels of satisfaction with the intervention and stated that it met almost all their needs. They all found the treatment to be highly credible. Hence, the second aim was supported, indicating that ACTwC was acceptable to people with BDD and elevated shame, and feasible to be delivered in a psychiatric outpatient setting.Strengths of this study include the randomized multiple baseline design that controlled for threats to internal validity, such as the passage of time and repeated assessments. Further, the daily assessment method has the advantage that it is sensitive to change and fluctuations in mood and behaviors. Additional strengths were the real-world setting and the large improvements across patients with considerable symptoms and low quality of life. Moreover, we used three different therapists who after moderate training were able to deliver treatment adequately, providing some initial evidence that the intervention can be successfully delivered in a real-world context.Single-case experimental designs (e.g., multiple baseline) are suitable for initial evaluation of psychological treatments (Another limitation of the study is the relatively unknown reliability and validity of the daily assessments of body shame and self-criticism. The daily measures consisted of single item questions that required participants to be able to understand these constructs. Identifying and discriminating self-conscious emotions can be difficult (
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Conclusions
depressive mood
In conclusion, the results from this pilot study suggest that ACT with Compassion has potential to reduce BDD symptoms, shame, and self-criticism, and in addition, improve depressive mood and patients’ quality of life. Also, the treatment was considered acceptable to the patients. Feedback and study results will be used to guide further development of the treatment protocol and future research that explores treatment moderators and mechanisms of change and evaluates efficacy of the intervention compared to other treatments in a larger randomized controlled trial.
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Supplemental Material
PMC10150257
sj-docx-1-bmo-10.1177_01454455221129989 – Supplemental material for Acceptance and Compassion-Based Therapy Targeting Shame in Body Dysmorphic Disorder: A Multiple Baseline Study
Dysmorphic Disorder
Click here for additional data file.Supplemental material, sj-docx-1-bmo-10.1177_01454455221129989 for Acceptance and Compassion-Based Therapy Targeting Shame in Body Dysmorphic Disorder: A Multiple Baseline Study by Johanna Linde, Jason B. Luoma, Christian Rück, Jonas Ramnerö and Tobias Lundgren in Behavior Modification
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References
PMC10150257
Background
DCIS, DUCTAL CARCINOMA IN SITU, RECRUITMENT, RECRUITMENT
The LOw RISk DCIS (LORIS) study was set up to compare conventional surgical treatment with active monitoring in women with ductal carcinoma in situ (DCIS). Recruitment to trials with a surveillance arm is known to be challenging, so strategies to maximise patient recruitment, aimed at both patients and recruiting centres, were implemented.
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Methods
anxiety
DCIS, RECRUITMENT
Women aged ≥ 46 years with a histologically confirmed diagnosis of non-high-grade DCIS were eligible for 1:1 randomisation to either surgery or active monitoring. Prior to randomisation, all eligible women were invited to complete: (1) the Clinical Trials Questionnaire (CTQ) examining reasons for or against participation, and (2) interviews exploring in depth opinions about the study information sheets and film. Women agreeing to randomisation completed validated questionnaires assessing health status, physical and mental health, and anxiety levels. Hospital site staff were invited to communication workshops and refresher site initiation visits to support recruitment. Their perspectives on LORIS recruitment were collected via surveys and interviews.
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Results
anxiety
SAID, RECRUITMENT
Eighty percent (181/227) of eligible women agreed to be randomised. Over 40% of participants had high anxiety levels at baseline. On the CTQ, the most frequent most important reasons for accepting randomisation were altruism and belief that the trial offered the best treatment, whilst worries about randomisation and the influences of others were the most frequent most important reasons for declining. Most women found the study information provided clear and useful. Communication workshops for site staff improved knowledge and confidence but only about half said they themselves would join LORIS if eligible. The most common recruitment barriers identified by staff were low numbers of eligible patients and patient preference.
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Conclusions
RECRUITMENT, RECRUITMENT
Recruitment to LORIS was challenging despite strategies aimed at both patients and site staff. Ensuring that recruiting staff support the study could improve recruitment in similar future trials.
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Trial registration
MAY
ISRCTN27544579, prospectively registered on 22 May 2014
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Supplementary Information
The online version contains supplementary material available at 10.1186/s13063-023-07703-4.
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Keywords
PMC10576350
Background
cancers
DCIS, CANCERS, DUCTAL CARCINOMA IN SITU
Ductal carcinoma in situ (DCIS) is a condition in which neoplastic breast cells are confined to the lining of breast ducts. It is classified into three histological grades—high, intermediate, and low—according to cyto-nuclear feature [In 2012, an independent panel reviewed the evidence on benefits and harms of screening in the context of the UK breast screening programmes. The resulting Marmot report concluded that whilst breast screening may extend lives, it also detects cancers which would not come to clinical attention during a woman’s life; such overdiagnosis has a negative impact on quality of life [The LOw RISk DCIS (LORIS) study was set up to examine if
PMC10576350
Methods
DCIS, DUCTAL CARCINOMA IN SITU
The LORIS study is a multi-centre, phase III RCT of surgery versus active monitoring with annual mammography in patients with low-risk ductal carcinoma in situ (DCIS) [
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Inclusion and exclusion criteria
blood-stained nipple
COMEDO, INVASIVE BREAST CANCER, BREAST CANCER, DCIS, MASS LESION, NECROSIS
Women aged ≥ 46 years with a histologically confirmed diagnosis of non-high-grade DCIS (unilateral or bilateral) in the last 90 days who were fit and willing to undergo surgery and able to provide written informed consent were eligible. Exclusion criteria included a previous diagnosis of ipsilateral DCIS or invasive breast cancer, a mass lesion not proven on biopsy to be a specific benign lesion, unequivocal comedo necrosis observed, recent onset ipsilateral blood-stained nipple discharge without benign explanation or being in a high-risk group for developing breast cancer.
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Registration and randomisation pathway
DCIS
Enrolment to LORIS was a two-step process; registration followed by randomisation (see Fig. Registration and randomisation pathwayWomen were eligible for randomisation into LORIS if a diagnosis of low-risk DICS was confirmed by central review. Those eligible for LORIS were consented and randomised 1:1 to either surgery, the contemporary standard treatment for DCIS, or active monitoring, i.e. annual mammograms for 10 years. Women who declined randomisation were invited to complete the Clinical Trials Questionnaire (CTQ), a widely used validated measure of reasons why patients agree or decline entry into RCTs [
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Measures
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Clinical Trial Questionnaire (CTQ)
Reasons for accepting or declining LORIS were collected using the CTQ [
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Spielberger State Trait Anxiety Inventory (STAI)
The STAI consists of two sets of 20 questions, each scored on a 4-point scale [
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EuroQol 5D-5 L (EQ-5D)
anxiety/depression
The EQ-5D is a health status measure, comprising five dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) [
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Short Form Health Survey- 36 version 2 (SF-36v2)
pain
The SF-36v2 is a health status measure covering eight domains: physical functioning, role participation with physical health problems, bodily pain, general health, vitality, social functioning, role participation with emotional health problems and mental health [
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Patient interviews
Semi-structured interviews were conducted with women willing to be randomised and those who were not (see
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Study information
Written materials and a film were produced to help women’s decision making about participation. Patient and public focus groups were held to inform the content of these materials [The film was divided into chapters for ease of re-viewing particular sections or could be played in full (see
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Support for sites
RECRUITMENT, BREAST
At the start of the project, communication workshops were delivered regionally to recruiting sites’ staff (see A year into the main trial, a funder monitoring visit highlighted recruitment rate concerns so a recovery plan was developed to increase recruitment. Postal surveys were sent to PIs, site leads, and then other members of the recruiting site teams. The surveys explored which specific aspects of the LORIS protocol were most challenging. In parallel to surveys, all PIs and site leads were invited to participate in semi-structured telephone interviews to discuss further recruitment challenges. The information derived from surveys and interviews helped identify those teams likely to benefit from either communication workshops or refresher site initiation visits (SIVs). For example, those raising concerns about discussing randomisation, dealing with patient preferences for different management, or HCPs with negative attitudes towards LORIS, were invited to communication workshops. Refresher SIVs were offered to teams who had experienced organisational changes, or who had diagnostic or pathway logistic challenges. In addition, a LORIS awareness poster and leaflet were created and made available within hospitals, breast screening units, published within the Association of Breast Surgeons bulletins and shared to Linked-In and Twitter.
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Statistical analyses
DCIS
SPSS Statistics version 26 (IBM SPSS Statistics for Windows, Version 26.0. Armonk, NY: IMB Corp) was used to produce descriptive statistics. Differences between acceptors (women with confirmed low-risk DCIS who were willing to be randomised) and decliners (women with confirmed low-risk DCIS who were not willing to be randomised) in endorsement of the statements on the CTQ were compared using chi-squared test or Fisher’s exact test as applicable. Paired sample
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Results
The CONSORT flow diagram is shown in Fig. CONSORT flow diagram
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Participants
The median age of the 181 acceptors was 58 years (range 46–88 years) and most were post-menopausal (117/181, 65%, post-menopausal; 19/181, 10%, peri-menopausal; 34/181, 19% pre-menopausal; 11/181, 6% menopausal status not known). The median age of the 92 acceptors interviewed post randomisation was 60 years (range 48–88 years), 62/92 (67%) had a partner and 55/92 (60%) were employed. The median age of the 8 decliners interviewed post randomisation was 55 years (range 48–70 years), 5/8 (63%) had a partner and 5/8 (63%) were employed.Table Baseline measure scores for women who consented to randomisation
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