title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Randomisation and blinding | BLIND | Participants who met the specified inclusion and exclusion criteria were assigned to one of four groups (RT group, HMB group, combination group, or control group receiving standard care) in a 1:1:1:1 ratio using a computer-generated random sequence. To ensure allocation concealment, each centre prepared sequentially co... | PMC10724983 | |
Intervention protocol | PMC10724983 | |||
Standard care | Participants in four groups received comprehensive rehabilitation and nutrition management, overseen by physicians and charge nurses. Early rehabilitation included activities such as passive joint mobilisation, passive sitting, bedside sitting, bicycle-assisted training, active bedside exercises, dynamic standing, assi... | PMC10724983 | ||
Resistance training (RT) | Administered, hip flexion | The intervention protocol encompassed three physical function levels: supine, sitting, and standing. Each level consisted of seven to eight actions, such as chest pressing, elbow flexion, rowing, ankle dorsiflexion, ankle plantarflexion, knee extension, hip flexion, bridge exercises, and abdominal breathing. These exer... | PMC10724983 | |
HMB intervention | The nutritional supplement used in this study was JIROU (EnterNutr, Guangzhou), containing 8.32 g of maltodextrin, 1.5 g of HMBCa, 0.1 g of sweet orange powder, and 0.08 g of sucralose per 10 g. It provided 34 kcal of energy and no protein. The supplement, which included 1.5 g of HMB, was dissolved in 100 ml of warm wa... | PMC10724983 | ||
Data collection and outcome measures | Outcome assessors were trained and masked to group allocation. Outcome measurements in this study were divided into four categories, that is, physical function, muscle strength, body composition, and health-related quality of life. | PMC10724983 | ||
Physical function | (1) Short Physical Performance Battery (SPPB) was used to assess physical function, comprising a standing balance test, four-metre walking speed, and five sit-to-stand tests, each item worth 0–4 points, with a total score of 0–12 points [(2) 6-Minute Walk Test (6MWT) To evaluate functional endurance capacity and mobili... | PMC10724983 | ||
Muscle strength | ICU-AW | CONTRACTION | (1) The MRC score was used to assess the muscle strength of the six major muscle groups of the extremities. Each group is divided into six levels according to the Oxford muscle strength scale, with a total score of 0–60. Higher scores represent greater muscle strength. MRC is considered the gold standard for the diagno... | PMC10724983 |
Body composition | appendicular skeletal muscle mass | Bioelectrical impedance analysis (BIA, NUTRILAB, AKERN, Italy) was utilised to assess fat-free mass (FFM), appendicular skeletal muscle mass (ASMM), skeletal muscle index (SMI), and phase angle (PhA). | PMC10724983 | |
Primary outcomes | SPPB and 6WMD were measured at hospital discharge. | PMC10724983 | ||
Secondary outcomes | ICU-AW | Assessments were conducted at each time point for body composition, MRC score, ICU-AW rate, grip strength, MMSE, HADS, SF-36, IES-R, and 60-day mortality, length of stay. | PMC10724983 | |
Quality control | (1) A multicentre research team was established with sufficient personnel and reasonable hierarchy to ensure smooth project implementation. ICU nurse managers served as sub-centre leaders, while overall execution in each sub-centre was handled by head educators or quality control nurses from the respective departments.... | PMC10724983 | ||
Statistical analysis | PMC10724983 | |||
Sample size determination | A pre-study power analysis conducted using G Power software estimated that approximately 24 patients per group (with a total of 96) were required to detect a 35% improvement in physical function between the control and treatment groups, with a power of 0.8 and an alpha level of 0.05.The data was processed using IBM SPS... | PMC10724983 | ||
General characteristics analysis | Normality of continuous variables was assessed using the SW-test, PP-plot, and QQ-plot. Normally distributed variables were described using mean and standard deviation, while non-normally distributed variables were described using median and interquartile range. Categorical variables were described using frequency and ... | PMC10724983 | ||
General linear mixed model | ICU-AW | SECONDARY, REGRESSION | The GLMM investigated discrepancies in SPPB and 6WMD at hospital discharge, as well as SF-36 and IESR scores at one month post-discharge. It also explored differences and trends in FFM, ASMM, SMI, and PhA among the four groups at various assessment time points: T0, T1w, T2w, and hospital discharge. Additionally, the GL... | PMC10724983 |
Results | PMC10724983 | |||
Patient characteristics | MODS, Comorbidity | MULTIPLE ORGAN DYSFUNCTION SYNDROME, MODS, CRITICALLY ILL | A total of 817 patients from 5 centres were initially assessed for study eligibility from July 2022 to December 2022. Among them, 699 were excluded due to not meeting the inclusion and exclusion criteria, while six declined to participate. Consequently, 112 patients were randomly allocated. Of these, eight patients wit... | PMC10724983 |
Delivery and adherence to the interventions | gastrointestinal reactions, gastrointestinal problems | The median duration of ICU stay prior to the study had no difference among four groups, as illustrated in Table The actual number of interventions conducted by the HMB group and the combination group were 22.0 and 18.0, with respective compliance rates of 91.22% and 92.03%, respectively. The cumulative number of incomp... | PMC10724983 | |
Daily activity and energy intake | delirium, gastrointestinal reactions | PROTEIN DEFICIENCY | There were no statistically significant differences between the four groups in terms of gastrointestinal reactions, average daily sitting time, walking time, cumulative energy deficiency, cumulative protein deficiency, or delirium (The differences in daily profile among the four groups | PMC10724983 |
Primary outcomes | EVENT | GLMM analysis revealed significant differences between the four groups in terms of SPPB overall score, balance ability, four-metre gait speed score, and 6MWD (Results of GLLM analysis for comparison of SPPB/6MWD/SF-36/IESRSPPB: Short Physical Performance Battery; 6WMD: Six-Minute Walk Distance; SF-36: Short-Form-36 Hea... | PMC10724983 | |
Secondary outcomes | PMC10724983 | |||
60-day mortality and length of stay | This study observed a 60-day mortality rate of 8.0%, with no cases in the RT group, and 10.7% (three cases) in each of the other three groups. The difference was not statistically significant (P > 0.05). Additionally, there were no significant differences ( | PMC10724983 | ||
Body composition | The results of the GLMM analysis indicated there were no statistically significant differences ( | PMC10724983 | ||
Health-related quality of life | There were no differences ( | PMC10724983 | ||
Discussion | muscle mass, ICU-AW, critically ill, muscle wasting | DISEASE, CRITICALLY ILL, MUSCLE WASTING | Our findings indicate that RT improved physical function, muscle strength, and physical activity in MICU patients to a comparable extent to the combined intervention group. However, neither RT, HMB intervention, nor the combined intervention demonstrated efficacy in reducing muscle wasting or enhancing patients’ self-r... | PMC10724983 |
Conclusion | This novel multicentre four-arm RCT has shown that multilevel RT intervention, with or without HMB intervention throughout the entire hospitalisation period, seems to enhance the physical function and muscle strength of MICU patients. However, none of these treatments had a significant impact on body composition or qua... | PMC10724983 | ||
Acknowledgements | We would like to express our gratitude to the medical team in the multi-centre intensive care units for their assistance and professional advice during the implementation of this study. | PMC10724983 | ||
Author contributions | TTW and HL designed the study and drafted the manuscript; LLC provided statistical advice and support; QLC provided clinical expertise and advice; XXL, YNZ, XXC, CJL, MLX, YQW, JBW and JX were responsible for conducting intervention and developing the data collection, HL participated in the development of the ethical r... | PMC10724983 | ||
Funding | This study was supported by Fujian Provincial Department of Science and Technology's guiding projects, China (NO: 2021Y0051). | PMC10724983 | ||
Declarations | PMC10724983 | |||
Ethics approval and consent to participate | This study rigorously adheres to ethical principles and respects the preferences of all participants. Before the study is conducted, the study purpose, content, and procedure must be completely explained, informed consent must be signed, and notification must be done properly. Under no circumstances may the researcher ... | PMC10724983 | ||
Consent for publication | Not applicable. | PMC10724983 | ||
Availability of data and materials | The datasets generated and/or analysed during the proposed study will be available from the corresponding author upon reasonable request. | PMC10724983 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10724983 | ||
References | PMC10724983 | |||
Background | trauma, depression, chronic depression, ill | Whether and how psychotherapies change brain structure and function is unknown. Its study is of great importance for contemporary psychotherapy, as it may lead to discovery of neurobiological mechanisms that predict and mediate lasting changes in psychotherapy, particularly in severely mentally ill patients, such as th... | PMC10652457 | |
Methods/design | chronic major depression, trauma | Patients with chronic major depression and a history of early life trauma will be recruited, assessed, and treated across 3 international sites: Germany, Switzerland, and the United States. They will be randomized to one of two treatment arms: either (1) once weekly psychoanalytic psychotherapies, or (2) 3–4 times week... | PMC10652457 | |
Discussion | depression, trauma | MODE may allow the identification of brain-based biomarkers that may be more sensitive than traditional behavioral and clinical measures in discriminating, predicting, and mediating treatment response. These findings could help to personalize care for patients who have chronic depression patients and early life trauma | PMC10652457 | |
Supplementary Information | The online version contains supplementary material available at 10.1186/s12888-023-05287-6. | PMC10652457 | ||
Keywords | Open access funding provided by University of Lausanne | PMC10652457 | ||
Introduction | PMC10652457 | |||
Chronic depression and psychoanalytic psychotherapy research | depression, major depression, chronic depression, depressive symptoms | DISORDER, PAT | Chronic depression is a common disorder. Population lifetime prevalence estimates are 3–15% for major depression [Patients with chronic depression require tailored psychotherapeutic treatments that address their specific clinical needs [Only a small number of studies, however, have assessed the effectiveness of long-te... | PMC10652457 |
Early trauma, frequency of sessions, and treatment effects in chronic depression | chronic depression, depressed, traumatization, trauma | An unexpected, post hoc finding of the LAC study was that more than 80% of chronically depressed patients participating in the study suffered from early trauma, and that these patients responded especially well to high frequency psychoanalytic psychotherapy, often achieving sustained, structural changes in personality ... | PMC10652457 | |
Psychotherapy research in depression using brain imaging | Several investigators have used brain imaging technologies to study the associations of psychotherapies with measures of brain structure and function [ | PMC10652457 | ||
Objectives | depressive, depressed | Although considerable evidence supports the clinical effectiveness of psychoanalytic therapies, we do not yet understand the mechanisms through which they improve symptoms and reduce functional impairments – knowledge that can further enhance treatment effectiveness, especially in the highest risk and most complex clin... | PMC10652457 | |
Specific aims and hypotheses | PMC10652457 | |||
AIM 1 | depressed, trauma | Identify how long-term psychoanalytic therapies change brain structure and function in chronically depressed patients with a history of early trauma and to assess how those changes differ in patients assigned randomly to either high or low frequency weekly sessions. | PMC10652457 | |
AIM 2 | Assess whether these brain changes significantly mediate clinical improvement over 1 year of treatment. | PMC10652457 | ||
Primary hypotheses | High compared with low frequency treatment will normalize brain structure and function. | PMC10652457 | ||
Brain structure | depression | Based on prior findings in chronic depression patients in an RCT of medication therapy vs placebo [ | PMC10652457 | |
Brain activation | High compared with low frequency treatment will produce greater change in brain activity (a greater degree of normalization relative to healthy control values) in ventral medial brain regions during the functional MRI (fMRI) Cyberball paradigm for social exclusion, and the changes in brain activity will significantly m... | PMC10652457 | ||
Functional connectivity | depressed | High compared with low frequency treatment will produce a greater change in measures of functional brain connectivity after 1 year of treatment during resting state fMRI, particularly in the default mode network (DMN), which likely subserves the capacity for free association. Based on prior findings in chronically depr... | PMC10652457 | |
Tissue microstructure | High compared with low frequency treatment will produce a more pronounced normalization of indices of tissue microstructure in white matter (increasing fractional anisotropy and decreasing mean diffusivity) measured with diffusion tensor imaging (DTI). | PMC10652457 | ||
Secondary hypotheses | PMC10652457 | |||
Psychopathology | depressive | Although high and low frequency treatments will both produce clinical improvement, improvement will be significantly greater for high frequency treatment in structural integration (measured with the Operationalized Psychodynamic Diagnosis Structure Questionnaire (OPD-SQ)), depressive symptoms (measured with the BDI-2),... | PMC10652457 | |
Metabolic profile (only for a subgroup in Frankfurt) | Proton MR Spectroscopy ( | PMC10652457 | ||
Methods/Design | PMC10652457 | |||
Study design | depressed | MODE is a randomized, parallel, superiority and single blinded controlled trial comparing the effectiveness of two active interventions – high frequency (Flow chart of the studyThis study design will overcome many of the limitations of prior psychotherapy effectiveness studies. It will include an active control conditi... | PMC10652457 | |
Inclusion and exclusion criteria | PMC10652457 | |||
Patients | patients•, major depression, bipolar affective, schizoaffective, depressed, dysthymia, psychotic symptoms, depression, chronic depression, schizophrenic, trauma | SCID | Patients between 21 and 60 years of age of all genders suffering from chronic depression will be included in the study. Patients must be continuously depressed for more than one year and currently meet a diagnosis of major depression or dysthymia. The SCID interview will confirm a yearlong history of depression. Only p... | PMC10652457 |
Healthy control participants | depression, psychiatric, trauma | PHYSICAL ILLNESS | Inclusion criteria are: (1) no history of prior or current psychiatric diagnoses (Structured Clinical Interview for DSM-SCID); (2) no prior history of trauma on any of the CTQ subscales; (3) 21–60 years of age; and (4) sufficient knowledge of the local language to undergo assessments. Exclusion criteria are: (1) seriou... | PMC10652457 |
All participants | Standard MRI exclusion criteria will apply (metallic tattoos, pacemakers, or other metallic implants). | PMC10652457 | ||
Intervention and comparator | depressed | Study intervention will be comprised of low frequency psychoanalytic psychotherapy (1 session a week) for early traumatized, chronically depressed patients and high frequency psychoanalytic psychotherapy (3–4 weekly sessions). The active comparator condition, low frequency psychoanalysis, delivered by study therapists ... | PMC10652457 | |
Primary outcomes: MRI brain measures | Assessment will comprise the following MRI brain measures. Anatomical MRI: measures of cortical thickness at all points across the cerebrum. Resting State Functional MRI (rsfMRI): measures of functional connectivity throughout the brain. Cyberball Task-Related Functional MRI (fMRI): measures of brain activation through... | PMC10652457 | ||
MRI Scanning | All scans will be acquired on 3.0 T scanners: Siemens Prisma (Frankfurt, Lausanne), Philips Achieva (CHLA). Signal-to-noise and contrast-to-noise was determined to be comparable across all scanning platforms (Tables Anatomical MRI1.0 mm176 slices1.0 mm176 slicesTask-based fMRI: cyberballResting-State fMRIDiffusion tens... | PMC10652457 | ||
Theoretical basis for the fMRI task used in MODE | depressed, trauma | Chronically depressed patients need to experience an intensive, professional, reliable, holding, and containing therapeutic relationship in order to both regain confidence in a "helping object" in the form of the therapist and develop a basic feeling of self-agency. According to psychoanalytic theory, severe early life... | PMC10652457 | |
Task-based fMRI ‘Cyberball’ paradigm | MODE will study the neurobiological mechanisms that subserve this evolving sense of interpersonal trust within patients over the first year of psychoanalytic therapy. We have adapted a task that participants perform while in the MRI scanner so as to identify the brain systems that support the cognitive, emotional, and ... | PMC10652457 | ||
Secondary outcome measures | psychiatric, chronic depression, trauma | DISORDERS | MODE will investigate whether and how brain changes are associated with common measures of change for patients with chronic depression and early trauma after one year of treatment. To achieve this aim and as recommended in meta-analytic reviews, various broad areas of patient’s functioning are assessed including (1) ps... | PMC10652457 |
Assessment of psychopathology | PMC10652457 | |||
Diagnosis | SCID | The Structured Clinical Interview for DSM (SCID, [ | PMC10652457 | |
Depression | Depressive | Depressive symptoms will be assessed using three instruments: (1) The Inventory of Depressive Symptom (QIDS; [ | PMC10652457 | |
Distress | The Symptom Check-List (SCL-90-R; [ | PMC10652457 | ||
Early life trauma | depressed, trauma | Early childhood trauma is recognized as one of the best predictors of response to psychotherapy for severely depressed patients ( [ | PMC10652457 | |
Patient trauma narratives | trauma | Patients will be asked to send a written trauma narrative to the study center with 5 keywords. After the year of study, the research team will send again the keywords to the participant and will ask them to write again their memories on trauma. The trauma narrative will be written freely, with the instruction to write ... | PMC10652457 | |
Dynamic personality functioning | PMC10652457 | |||
Psychodynamic functioning and change | psychosomatic disorders, illness | The Operationalized Psychodynamic Diagnosis (OPD) is a form of multiaxial diagnostic system based on five axes: I = experience of illness and prerequisites for treatment, II = interpersonal relations, III = conflict, IV = structure and V = mental and psychosomatic disorders ( [ | PMC10652457 | |
Dream diary | chronic depression, trauma | Dreams will be collected in dream diaries ideally at each follow-up points and latest at study termination with the intent to examine dream characteristics in participants with chronic depression and early trauma. Participants can write freely about their dreams. To help participants document their dreams, an exemplary... | PMC10652457 | |
Psychosocial functioning | PMC10652457 | |||
Interpersonal problems | The Inventory of Interpersonal Problems (IIP; [ | PMC10652457 | ||
Interpersonal trust | Primal trust in a helping Other has been proposed as an important feature of therapeutic interaction [ | PMC10652457 | ||
Therapeutic Alliance | Alliance plays an important role in effective psychotherapy [ | PMC10652457 | ||
The Global Assessment of Functioning (GAF) | Is a numeric scale (0 through 100) used by an independent coder to rate the social, occupational and psychological level of functioning [ | PMC10652457 | ||
Work Ability Index (WAI-SR) | A previous study found that short- and long-term psychodynamic psychotherapy were differentially effective in improving work ability [ | PMC10652457 | ||
MRI Scanning MR spectroscopy (1H MRS) | Scans are acquired on 3.0 T scanners, Siemens Prisma in Frankfurt subgroup only. Spectroscopy was performed at the end of the MRI examination. An axial slice was recorded with 2D MRSI using an acquisition weighted circular phase encoding scheme on a 20 × 20 matrix, FOV of 240 × 240 mm | PMC10652457 | ||
Procedures | PMC10652457 | |||
Data collection sites | RECRUITMENT | Recruitment and treatment sites will be located in one center in the US (Los Angeles) and six centers in Europe (Germany: Frankfurt a.M., Cologne, Leipzig, Giessen, Mainz; and Switzerland: Lausanne). MRI scanning occurs in Los Angeles, Frankfurt a.M., and Lausanne. MRI data are processed in Los Angeles (CHLA). A clinic... | PMC10652457 | |
Patient recruitment | psychiatric, chronic depression, mood disorders | Patients will be recruited in private psychotherapeutic and psychiatric practices, in outpatient clinics for mood disorders in hospitals. Patient flyers describing study aims and procedures will be available to potential participants with a likely diagnosis of chronic depression. Healthy controls will be recruited thro... | PMC10652457 | |
Presentation of the study and informed consent procedures | chronic depression, trauma | The study will be presented to potential participants. Documents explaining the study, with its aims, procedures, benefits and risks for the participants will be provided to the participants. Interested subjects will be given a period to consider whether they would like to participate and the research team will be at t... | PMC10652457 | |
Randomization | The randomization procedure will consist of a computer-generated sequence of random numbers using SPSS (SPSS Statistics, version 28), which will then be used to allocate patients to either of the 2 treatment arms. The randomization sequence will be generated and maintained by an independent study administrator in Frank... | PMC10652457 | ||
Blinding | SCID | All the members of the investigating team (SCID /LIFE interviewers, MRI team etc.) will be blinded (they do neither know the treatment arm nor the names of the study therapists). | PMC10652457 | |
Rater training | SCID | SCID interviewers will be masters-level psychologists, previously trained on administration of SCID and supervised be a senior study investigators. | PMC10652457 | |
Manualized psychotherapeutic interventions | In the LAC study, therapists were trained in the specific treatment technique of psychoanalysis using the Tavistock Manual [ | PMC10652457 | ||
Therapist selection and training | Both interventions will be delivered by board certified psychoanalytic therapists which have trainings and clinical experiences in low frequent and high frequent psychoanalytic therapies. Trained therapists will deliver both treatments, depending on their availability and vacancies at the time of participant enrollment... | PMC10652457 | ||
Clinical supervision | Gilles Ambresin | All study therapists will participate in monthly group supervisions or in one of the monthly “Clinical Conferences” (chairs in Germany: Marianne Leuzinger-Bohleber, Tamara Fischmann, in Lausanne: Gilles Ambresin, in SF/LA: Cheryl Goodrich), where therapists present their ongoing psychoanalyses with study patients. | PMC10652457 | |
Recording and transcription | CPPS | A random selection of therapy sessions will be audiotaped. Adherence to the treatment protocol will be assessed by independent members of the research teams using the Comparative Psychotherapy Process Scale (CPPS; [ | PMC10652457 | |
Power calculation | chronic depression | Power analyses using MRI measures from prior RCTs of medication therapy for the treatment of chronic depression [ | PMC10652457 | |
Data analysis | depressed | Analyses will follow an intent-to-treat strategy comparing patients in the groups to which they were originally randomized.All data will be scored and rescored by separate staff members and checked for accuracy prior to double entry into a REDCap database. Before conducting inferential statistics, we will explore data ... | PMC10652457 | |
Missing data | We will model missing responses/covariates in our longitudinal models. We will consider missing data mechanisms, including missing completely at random, missing at random, or missing not at random, to handle missing data due to a missed assessment time point, study dropout, or unusable MRIs. The full information maximu... | PMC10652457 | ||
Discussion | major depression, trauma | The findings of MODE will be relevant for both clinical and basic research in identifying the brain-based mechanisms whereby psychotherapy exerts its therapeutic effects. MODE is, to our knowledge, the first study to investigate the neurobiological changes in response the effects of intensive psychoanalytic psychothera... | PMC10652457 |
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