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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Reporting summary | Further information on research design is available in the | PMC10824665 | ||
Supplementary information |
Supplementary Figs. 1–4.Reporting SummarySupplementary protocols.Supplementary Tables 1–10 | PMC10824665 | ||
Source data |
Statistical Source Data.Statistical Source Data.Statistical Source Data.Statistical Source Data.Statistical Source Data.Statistical Source Data.Statistical Source Data.Statistical Source Data.Statistical Source Data.Statistical Source Data.Statistical Source Data.Statistical Source Data.Uncropped blots.Statistical Sou... | PMC10824665 | ||
Extended data | PMC10824665 | |||
The effect of imetelstat on normal hematopoiesis. | Humanized
| PMC10824665 | ||
Lipidomics analysis of imetelstat-treated | desaturation | Targeted lipidomics analysis on 593 lipid species and their desaturation levels.
| PMC10824665 | |
The effect of chemical perturbation of ferroptosis on imetelstat efficacy. | Celltiter-based cell growth analysis in a panel of
| PMC10824665 | ||
Individual AML PDX responses to imetelstat. | Peripheral blood AML | Peripheral blood AML donor chimerism in the thirty individual PDX models.
| PMC10824665 | |
Extended data | is available for this paper at 10.1038/s43018-023-00653-5. | PMC10824665 | ||
Supplementary information | The online version contains supplementary material available at 10.1038/s43018-023-00653-5. | PMC10824665 | ||
Acknowledgements | Leukaemia, P. | LEUKAEMIA | We acknowledge all current and past members of the Gordon and Jessie Gilmour Leukaemia Research Laboratory, particularly E. Cooper, G. Pali, E. Duce, R. Austin, T. Vu, M. Bywater and P. Tavakoli for technical assistance and fruitful discussions; S. Chun-Wei Lee (MSKCC) for help with library preparation for HemePACT seq... | PMC10824665 |
Author contributions | C.B., L.J.B., L.B., F.H.H., M.M.H., G.A.K., H.A.P., O.A.W. and S.W.L. were responsible for conceptualization. The methodology was the responsibility of C.B., A.H.P., T.S., J.S., V.L., B.J., G.H. and S.W.L. Software was the responsibility of J.S. and G.H. Validation was carried out by C.B., A.H.P., A.P.S. and G.V.W. For... | PMC10824665 | ||
Peer review | PMC10824665 | |||
Data availability | RNA-sequencing data have been deposited in the Gene Expression Omnibus under accession codes | PMC10824665 | ||
Competing interests | S.W.L. has received research funding from Janssen related to imetelstat (2016–2018). For research beyond this study, S.W.L. has received funding from Celgene/Bristol Myers Squibb (2019–2022), consultancy from Abbvie (2021–2023) and advisory board fees from Abbvie and Astellas (2020–2021). The remaining authors declare ... | PMC10824665 | ||
References | PMC10824665 | |||
Background | Patient selection is key in Phase I studies, and prognosis can be difficult to estimate in heavily pre-treated patients. Previous prognostic models like the Royal Marsden Hospital (RMH) score or using the neutrophil–lymphocyte ratio (NLR) have not been validated in current novel therapies nor in the Asian Phase I popul... | PMC10070409 | ||
Methods | SOLID TUMOUR | We conducted a retrospective review of 414 patients with solid tumours participating in Phase I studies at our centre between October 2013 and December 2020. | PMC10070409 | |
Results | The RMH model showed poorer prognosis with increasing scores [RMH score 1, HR 1.28 (95% CI: 0.96–1.70); RMH score 2, HR 2.27 (95% CI: 1.62–3.17); RMH score 3, HR 4.14 (95% CI: 2.62–6.53)]. NLR did not improve the AUC of the model. Poorer ECOG status (ECOG 1 vs. 0: HR = 1.59 (95% CI = 1.24–2.04), | PMC10070409 | ||
Conclusions | We developed a NCIS prognostic score with excellent prognostic ability for both short-term and longer-term survival (iAUC: 0.71 [95% CI 0.65–0.76]), and validated the RMH model in the largest Asian study to date. | PMC10070409 | ||
Subject terms | PMC10070409 | |||
Introduction | malignancies, tumour | MALIGNANCIES, TUMOUR, SIDE EFFECT | Our understanding of tumour biology has grown exponentially and a large number of novel molecularly targeted agents and immunotherapy have entered the clinic. Many of these agents have different side effect profiles compared to cytotoxic chemotherapy and their development plan may differ, with an emphasis on understand... | PMC10070409 |
Methods | PMC10070409 | |||
Study design and patient characteristics | cancer, death, tumour, Cancer | CANCER, SOLID TUMOUR, TUMOUR, CANCER | We conducted a retrospective review of patients with solid tumours participating in Phase I studies at the National University Cancer Institute, Singapore (NCIS) between October 2013 and December 2020. Patients enrolled in the studies fulfilled the eligibility criteria of the respective studies. Patient demographics, c... | PMC10070409 |
Statistical considerations | death | REGRESSION | Categorical variables were summarised based on counts and percentages while continuous variables were described in terms of median and interquartile range (IQR).Overall survival (OS) duration was measured from the start of therapy to the date of death. Patients who remained alive at the end of study were censored at th... | PMC10070409 |
Model validation | Both the RMH and RMH + NLR50 models were externally validated using the NCIS data, and their performances were evaluated using Harrell’s C-statistic and time-dependent area under the curve (AUC( | PMC10070409 | ||
Model update | tumour | TUMOUR | In addition to the RMH score, the following covariates were considered for the model update: gender, age, ECOG performance status (PS), number of co-morbidities, number of prior therapies, aspartate aminotransferase (AST), platelets, haemoglobin, NLR, tumour classification, and whether they were treated with chemothera... | PMC10070409 |
Results | PMC10070409 | |||
Study population | head and neck cancers, gynaecological cancer, lung cancer, Arkenau, lymphoma | LUNG CANCER, OTHER CANCER, HEPATOCELLULAR CARCINOMA, HEAD AND NECK CANCER, LYMPHOMA | There were 414 patients (157 [38%] male and 257 [62%] female) recruited in 40 Phase I studies at NCIS (Table Baseline and treatment characteristics.Note: 1. The figures are presented in terms of frequency and percentage, unless otherwise stated.2. Arkenau et al. [3. In total, 12 patients in the NCIS study population di... | PMC10070409 |
Development of the NCIS Prognostic Score | tumour | TUMOUR | From the updated NCIS model comprising the following significant predictors (RMH score, ECOG PS and tumour type) (Table NCIS prognostic scoring.Overall survival according to NCIS Prognostic Score for patients enrolled in Phase I trials.The three prognostic models performed similarly in predicting 90-day mortality with ... | PMC10070409 |
Discussion | cancers, cancer, tumour, deaths, Cancer | CANCER, CANCERS, TUMOUR, CANCER | Similar to other studies, we found the 90-day mortality rate in Phase I studies in our patient population to be ~17%, but treatment-related deaths were very rare [Compared to the original RMH score validation cohort [Our study is one of the first studies aiming to validate the RMH score in the Asian population particip... | PMC10070409 |
Author contributions | JL and CEC were responsible for the concept and design of the study. JL, JW and JC were involved in data collection. BCT and AC were involved in data analysis. JL, AC, BCT and CEC drafted the manuscript. All authors critically revised the manuscript for important intellectual content. CEC supervised the study. All auth... | PMC10070409 | ||
Funding | This research is supported by the Singapore Ministry of Health’s National Medical Research Council under its NMRC Centre Grant Programme, NMRC/CG/012/2013. | PMC10070409 | ||
Data availability | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10070409 | ||
Competing interests | RS, Cancer | ONCOLOGY, CANCER | WPY has advisory roles for Abbvie/Genentech, Amgen, Astra Zeneca, Bristol-Myers Squibb, Ipsen and Novartis. He is part of the Speakers’ Bureau for Bayer, Eisai, Lilly, MSD Oncology, Sanofi/Aventis, Taiho Pharmaceuticals. He has received funding for travels and accommodations from Pfizer. RS (Raghav Sundar) has received... | PMC10070409 |
Ethics approval and consent to participate | The study was approved by the institutional review board. The need for consent was waived by the institutional review board. | PMC10070409 | ||
Consent to publish | Not applicable. | PMC10070409 | ||
References | PMC10070409 | |||
2. Materials and Methods | PMC10096552 | |||
2.1. Research Ethics and Participants | The present study adhered to the principles of the Declaration of Helsinki and the Ethical Guidelines for Medical and Health Research Involving Human Subjects. Documents such as the study protocol, the investigator’s brochure, the explanation form, and the consent form were submitted to the ethics committee of the Facu... | PMC10096552 | ||
2.2. Test Food | The study used LC-Plasma capsules containing heat-killed dry LC-Plasma (Kyowa Hakko Bio CO., Ltd., Tokyo, Japan) (≥1.0 × 10 | PMC10096552 | ||
2.3. Study Design | The schematic representation of the study is shown in The participants were instructed to maintain their daily habits (e.g., for diet and sleep) and to avoid foods containing a large amount of lactic acid bacteria (e.g., yogurt, fermented cheese, pickles, and lactic acid bacteria supplement) within the test period. For... | PMC10096552 | ||
2.4. Evaluation of pDC and mDC Activity | Peripheral blood mononuclear cells (PBMCs) were isolated from the blood [ | PMC10096552 | ||
2.5. Evaluation of Hematological Indices | inflammation | INFLAMMATION, OXIDATIVE STRESS | To investigate the influence of exercise load and LC-Plasma intake on the objective parameters, hematological indices known to be associated with exercise-induced inflammation and oxidative stress were measured. The levels of transforming growth factor-β (TGF-β) and interleukin-6 (IL-6) were measured using an ELISA kit... | PMC10096552 |
2.6. Evaluation of Physiological Indices | fatigue | The low frequency to high frequency ratio (LF/HF), which is indicative of sympathetic to parasympathetic autonomic balance, was measured to assess the degree of fatigue, using the autonomic measurement device VM302 (Hitachi Systems, Tokyo, Japan) [ | PMC10096552 | |
2.7. Participant Diary and Questionnaire | fatigue, pharyngeal pain, ’ mood, pain, cough, muscle pain | Participants were asked to record the degree of each clinical symptom (physical conditions, nasal congestion/nasal discharge, pharyngeal pain, cough, joint pain, chill, fatigue, malaise, and muscle pain) daily using a five-point Likert scale modified with reference to a previous report [To evaluate the participants’ mo... | PMC10096552 | |
2.8. Statistical Analysis | SECONDARY | The primary endpoints were pDC activity, mDC activity, participant diary records, POMS2, and TGF-β, IL-6, CPK, cathepsin L, and adrenaline levels between the PL group and the LC-Plasma group on day 15. The secondary endpoints were VAS score, LF/HF, and 8-OHdG, testosterone and leptin levels. Data were expressed as the ... | PMC10096552 | |
3. Results | PMC10096552 | |||
3.2. Assessment for Continuous Exercise | fatigue, pain | We first analyzed the effect of LC-Plasma on continuous exercise. There was a significant decrease in pDC activity (CD86) on day 15 compared with that on day 1 in both groups, and on day 15, the level in the LC-Plasma group was significantly higher than that in the PL group (The cumulative days of fatigue in the partic... | PMC10096552 | |
3.3. Assessment for Strenuous Single Exercise | muscle pain, listlessness | Next, we analyzed the effect of LC on a single exercise session following long-term exercise. There were no significant differences in DC activity and the POMS2 score in the intra- or intergroup comparisons. The score for the item “Are you tired?” and “Are you feeling physical listlessness?” in VAS showed a significant... | PMC10096552 | |
4. Discussion | heart and skeletal muscle, fatigue, Fatigue | CONTRACTION | The primary aim of this study was to confirm the effects of LC-Plasma on fatigue caused by a continuous high training load. All the participants in this study belonged to the same sports club. Since the participants had had 3 days of rest without exercise before the start of the test, it is considered that the fatigue ... | PMC10096552 |
5. Conclusions | fatigue | The present study demonstrated that supplementation with LC-Plasma reduced the accumulation of subjective feelings of fatigue after continuous exercise in participants who routinely exercised, potentially by maintaining pDC activity. In addition, the possibilities of improvements in indices of fatigue, such as the norm... | PMC10096552 | |
Author Contributions | H.N. | Conceptualization, Y.K., K.S. and T.F.; methodology, Y.K., K.F., Y.I. and T.F.; validation, K.S., H.N. and H.D.; investigation, Y.K., K.F., Y.I. and T.K.; writing—original draft preparation, Y.K. and T.K.; writing—review and editing, K.S., H.N., T.F. and H.D.; supervision, K.S., H.N. and H.D.; project administration, Y... | PMC10096552 | |
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki, and approved by the Ethics Committee of the Faculty of Health and Sports Science, Juntendo University (approval number: 29–13). The protocol was registered in University Hospital Medical Information Network Clinical Trial Registry as UMIN000028717. | PMC10096552 | ||
Informed Consent Statement | Informed consent was obtained from all participants involved in the study. | PMC10096552 | ||
Data Availability Statement | Not applicable. | PMC10096552 | ||
Conflicts of Interest | The study was funded by Kirin Holdings Company, Limited. Y.K., T.F. and T.K. are employees of this company. Although conducted in a double-blind study, they were involved in the investigation, analyses, and writing of the manuscript. The authors declare no other conflict of interest. | PMC10096552 | ||
Background | xerostomia, LA-SCCHN, squamous cell carcinoma of the head and neck (, ototoxicity | XEROSTOMIA, ADVERSE EVENTS, DYSFUNCTION, HYPOTHYROIDISM, OTOTOXICITY | Chemoradiotherapy (CRT) with concurrent cisplatin is the standard of care as a nonsurgical definitive treatment for patients with locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). However, CRT is associated with increased severe late adverse events, including swallowing dysfunction, xerostomia, ... | PMC10626703 |
Methods | LA-SCCHN, oropharynx cancer, tumors | TUMORS, OROPHARYNX CANCER | This study is a multicenter, two-arm, open-label, randomized phase III trial. Patients with LA-SCCHN excluding p16 positive oropharynx cancer are randomized to the standard arm or experimental arm. A total dose of 70 Gy for tumors with concurrent cisplatin at 100 mg/m | PMC10626703 |
Discussion | If the experimental arm is non-inferior to the standard arm in terms of TTF and superior on the safety endpoints, the 2-step40 procedure is the more useful treatment than SIB56 for definitive CRT. | PMC10626703 | ||
Trial registration | This trial has been registered in the Japan Registry of Clinical Trials as jRCTs031210100 ( | PMC10626703 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12885-023-11503-z. | PMC10626703 | ||
Keywords | PMC10626703 | |||
Background | dysphagia, two-step40, LA-SCCHN, squamous cell carcinoma of the head and neck (, oropharyngeal cancer | DYSPHAGIA, RECURRENCE, ADVERSE EVENTS, OROPHARYNGEAL CANCER, PRIMARY TUMOR | Chemoradiotherapy (CRT) with concurrent high-dose cisplatin (CDDP) is a standard treatment for patients with locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) [Intensity-modulated radiation therapy (IMRT) has emerged as a current standard method for definitive CRT for LA-SCCHN. Although the advan... | PMC10626703 |
Methods/design | PMC10626703 | |||
Study design | ONCOLOGY, MAY | This study is a multi-institutional, two-arm, open-label, randomized phase III study. The study protocol was reviewed by the Japan Clinical Oncology Group (JCOG) Protocol Review Committee and approved by as the JCOG1912 (NEW BRIDGE) in January 2021. The certificated review board approved in March 2021, and patient accr... | PMC10626703 | |
Endpoints | death | ADVERSE EVENTS, EVENT, EVENTS, SECONDARY, RESIDUAL DISEASE | The primary endpoint is time to treatment failure (TTF) 1 in all randomized patients. TTF1 is defined as time from randomization to the date of progression, or determination of residual disease after the completion of the protocol treatment, or death from any cause, whichever occurred first, and it is censored at the l... | PMC10626703 |
Eligibility criteria | Active infection, Psychiatric disorder, cancers, myocardial infarction, Tumor, head and neck cancers, head and neck surgeon, valvular disease, intramucosal tumors, human immunodeficiency virus antibody test., Fever, squamous cell carcinoma, tumors, head or neck lesions | CANCERS, UNCONTROLLED HYPERTENSION, MYOCARDIAL INFARCTION, LYMPH NODE METASTASES, TUMOR, DILATED CARDIOMYOPATHY, POSITIVE, UNSTABLE ANGINA, HYPERTROPHIC CARDIOMYOPATHY, OROPHARYNGEAL CANCER, HEAD AND NECK CANCER, ONCOLOGY, SQUAMOUS CELL CARCINOMA, TUMORS, POORLY CONTROLLED DIABETES MELLITUS | The inclusion criteria are as follows:
Primary lesions are located in the oropharynx, hypopharynx, or larynx.Histologically proven squamous cell carcinoma on biopsy specimens of the primary lesion. Immunohistochemistry reveals p16 negativity in patients with oropharyngeal cancer.Clinical stage of III, IVA, or IVB (excl... | PMC10626703 |
Randomization | METASTASIS | After eligibility has been confirmed, registration is performed using a web-based system at the JCOG Data Center. Patients are randomized to the standard arm (SIB56) or experimental arm (2-step40). Randomization is stratified according to the institution, presence or absence of lymph nodes metastasis, and the primary s... | PMC10626703 | |
Treatment methods | tumor, SCCHN | SQUAMOUS CELL CARCINOMA, TUMOR, PRIMARY TUMOR | Patients in both arms receive definitive CRT with CDDP at a dose of 100 mg/m
Study scheme. SCCHN, squamous cell carcinoma of the head and neck; CDDP, cisplatin; SIB, simultaneous integrated boostRadiation planning is performed 2 weeks before the start of RT. The cervical computed tomography (CT) is performed using a th... | PMC10626703 |
Statistical analysis and evaluation criteria for the endpoints | dysphagia, dry mouth | DYSPHAGIA, ADVERSE EVENTS, HEARING IMPAIRMENT, HYPOTHYROIDISM, DRY MOUTH | A 3-year TTF1 of 50% is assumed for both arms. According to the Schoenfeld and Richter’s method [If the experimental arm is non-inferior to the standard arm in terms of TTF1 and superior in terms of safety endpoints, the 2-step40 method will be considered the more efficacious treatment. However, it is unacceptable that... | PMC10626703 |
Interim analysis and monitoring | Two interim analyses considering multiplicity will be conducted using the Lan and DeMets method along with the O’Brien and Fleming-type alpha spending function [In the first interim analysis, if both the non-inferiority and superiority of the experimental arm over the standard arm in terms of the primary endpoint are d... | PMC10626703 | ||
Cases review | RECURRENCES, RECURRENCE, HEAD AND NECK CANCER | Cases of patients who undergo salvage surgery after the completion of the protocol treatment will be presented at the JCOG Head and Neck Cancer Study Group conference held every 6 months to review indications for surgery and the appropriateness of the surgical procedure. Cases with regional recurrence will be reviewed ... | PMC10626703 | |
Discussion | toxicity, toxicities, LA-SCCHN, deaths, JAVELIN, ototoxicity | ADVERSE EVENTS, DISEASE, OTOTOXICITY | The current CRT regimen for patients with LA-SCCHN is associated with severe late adverse events, decreased QOL, and increased noncancer-related deaths in long-term survivors. The ideal treatment for patients with LA-SCCHN is a modality that is satisfactory for both disease control and the patients’ daily lives. Our tr... | PMC10626703 |
Participating institutions | Cancer | INFECTIOUS DISEASES, SHIGA, HEAD AND NECK CANCER, CANCER | This study is a within-JCOG intersubgroup study collaborating between the Radiation Therapy Study Group and the Head and Neck Cancer Study Group. The participating institutions are those that meet the criteria for RT quality control and quality assurance and have approval from the JCOG Radiation Therapy Committee to pe... | PMC10626703 |
Acknowledgements | ONCOLOGY, ADVERSE EVENT, HEAD AND NECK CANCER | The authors thank in advance all the patients, investigators and institutions involved in this trial. The authors thank Ms. Shoko Todo and Ms. Naoko Otomo in JCOG Data Center for data management for this trial, and Ms. Harumi Suzuki in Data and Safety Monitoring Committee Office of the JCOG for support to adverse event... | PMC10626703 | |
Authors' contributions | The study concept was conceived by TY, SZ, TK, and NK. The study was designed by TY, SZ, TK, NK, RT, YF, and KW. TY, SZ, TK, and NK are the primary authors of the protocol; however, all authors have contributed in this regard to some extent. TY, SZ, TK, and NK wrote the manuscript. RT, YF, NK, and KW play central roles... | PMC10626703 | ||
Funding | Cancer | CANCER | This study was supported by The Japan Agency for Medical Research and Development (AMED) (JP22ck0106751) and the National Cancer Center Research and Development Funds (2020-J-3, 2023-J-03). The funding body has peer reviewed the study design. However, the funding agencies had no influence on the study design and data c... | PMC10626703 |
Availability of data and materials | Not applicable. | PMC10626703 | ||
Declarations | PMC10626703 | |||
Ethics approval and consent to participate | CRB, Cancer | CANCER | The study protocol was approved by the National Cancer Center Hospital East Certified Review Committee (CRB) on January 2021 first (CRB3180009). Modifications to the study protocol will be communicated to the CRB. The CRB will revise the informed consent materials to be given to participants and adapt them in accordanc... | PMC10626703 |
Consent for publication | All patients will be required to provide written informed consent for the publication of the results. | PMC10626703 | ||
Competing interests | The authors declare no competing interests. | PMC10626703 | ||
References | PMC10626703 | |||
Key Points | PMC10034662 | |||
Question | depression | Is practitioner-supported mindfulness-based cognitive therapy self-help (MBCT-SH) clinically effective and cost-effective compared with practitioner-supported cognitive behavioral therapy self-help (CBT-SH) for adults experiencing mild to moderate depression? | PMC10034662 | |
Findings | depression, depressive | In this randomized clinical trial of 410 participants with mild to moderate depression, practitioner-supported MBCT-SH led to significantly greater reductions in depressive symptom severity at 16 weeks postrandomization compared with practitioner-supported CBT-SH. The probability of MBCT-SH being cost-effective compare... | PMC10034662 | |
Meaning | depression, depressive | Practitioner-supported MBCT-SH for mild to moderate depression was clinically effective and cost-effective compared with currently recommended practitioner-supported CBT-SH and should be made routinely available to adults experiencing mild to moderate depression.This randomized clinical trial evaluates whether practiti... | PMC10034662 | |
Importance | depression, Depression | Depression is prevalent. Treatment guidelines recommend practitioner-supported cognitive behavioral therapy self-help (CBT-SH) for mild to moderate depression in adults; however, dropout rates are high. Alternative approaches are required. | PMC10034662 | |
Objective | depressive, depression | To determine if practitioner-supported mindfulness-based cognitive therapy self-help (MBCT-SH) is superior to practitioner-supported CBT-SH at reducing depressive symptom severity at 16 weeks postrandomization among patients with mild to moderate depression and secondarily to examine if practitioner-supported MBCT-SH i... | PMC10034662 | |
Design, Setting, and Participants | depression | RECRUITMENT | This was an assessor- and participant-blinded superiority randomized clinical trial with 1:1 automated online allocation stratified by center and depression severity comparing practitioner-supported MBCT-SH with practitioner-supported CBT-SH for adults experiencing mild to moderate depression. Recruitment took place be... | PMC10034662 |
Interventions | Participants received a copy of either an MBCT-SH or CBT-SH workbook and were offered 6 support sessions with a trained practitioner. | PMC10034662 | ||
Main Outcomes and Measures | The preregistered primary outcome was Patient Health Questionnaire (PHQ-9) score at 16 weeks postrandomization. The primary analysis was intention-to-treat with treatment arms masked. | PMC10034662 | ||
Results | depression, −2.6 | Of 410 randomized participants, 255 (62.2%) were female, and the median (IQR) age was 32 (25-45) years. At 16 weeks postrandomization, practitioner-supported MBCT-SH (n = 204; mean [SD] PHQ-9 score, 7.2 [4.8]) led to significantly greater reductions in depression symptom severity compared with practitioner-supported CB... | PMC10034662 | |
Conclusions and Relevance | depression | In this randomized clinical trial, practitioner-supported MBCT-SH was superior to standard recommended treatment (ie, practitioner-supported CBT-SH) for mild to moderate depression in terms of both clinical effectiveness and cost-effectiveness. Findings suggest that MBCT-SH for mild to moderate depression should be rou... | PMC10034662 | |
Trial Registration | isrctn.org Identifier: | PMC10034662 | ||
Introduction | depression, Depression | Depression has a lifetime prevalence of 10.8% worldwide.To widen access, cognitive behavioral therapy self-help (CBT-SH) supported by a trained practitioner is recommended in the treatment of mild to moderate depression in national treatment guidelines.Mindfulness-based cognitive therapy (MBCT) is an in-person group pr... | PMC10034662 | |
Method | PMC10034662 | |||
Design | depression | This was a multicenter, pragmatic, assessor- and participant-blinded (participants were unaware of which intervention was hypothesized to be superior), parallel, superiority RCT with 1:1 allocation comparing practitioner-supported MBCT-SH with CBT-SH for adults experiencing mild to moderate depression in 10 Improving A... | PMC10034662 | |
Participants | Inclusion criteria were that participants (1) were 18 years or older; (2) met criteria on the Clinical Interview Schedule–Revised (CIS-R) | PMC10034662 |
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