Objective To address uncertainties prior to conducting a fully powered randomised controlled trial of Morita Therapy plus treatment as usual (TAU) versus TAU alone, or to determine that such a trial is not appropriate and/or feasible.
Design Pilot parallel group randomised controlled feasibility trial.
Setting and participants Participants aged ≥18 years with Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV major depressive disorder, with or without DSM-IV anxiety disorder(s), recruited from general practice record searches in Devon, UK.
Interventions We randomised participants on a 1:1 basis stratified by symptom severity, concealing allocation using a secure independent web-based system, to receive TAU (control) or 8–12 sessions of Morita Therapy, a Japanese psychological therapy, plus TAU (intervention).
Outcomes Rates of recruitment, retention and treatment adherence; variance and estimated between-group differences in follow-up scores (on the Patient Health Questionnaire 9 (PHQ-9) (depressive symptoms); Generalised Anxiety Disorder Questionnaire 7 (anxiety symptoms); Short Form 36 Health Survey Questionnaire/Work and Social Adjustment Scale (quality of life); Morita Attitudinal Scale for Arugamama (attitudes)) and their correlation with baseline scores.
Results We recruited 68 participants, 5.1% (95% CI 3.4% to 6.6%) of those invited (34 control; 34 intervention); 64/68 (94%; 95% CI 88.3% to 99.7%) provided 4-month follow-up data. Participants had a mean age of 49 years and mean PHQ-9 score of 16.8; 61% were female. Twenty-four of 34 (70.6%) adhered to the minimum treatment dose. The follow-up PHQ-9 (future primary outcome measure) pooled SD was 6.4 (95% CI 5.5 to 7.8); the magnitude of correlation between baseline and follow-up PHQ-9 scores was 0.42 (95% CI 0.19 to 0.61). Of the participants, 66.7% and 30.0% recovered in the intervention and control groups, respectively; 66.7% and 13.3% responded to treatment in the intervention and control groups, respectively.
Conclusions A large-scale trial of Morita Therapy would require 133 participants per group and is feasible with minor modifications to the pilot trial protocol. Morita Therapy shows promise in treating depression and may provide patients with a distinct alternative to current treatments.
Trial registration number ISRCTN17544090; Pre-results.
- morita therapy
- feasibility study
- pilot randomised controlled trial
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Contributors DAR proposed the study; HVRS as chief investigator and study researcher designed the study with the involvement of DAR and JF; HVRS drafted the study protocol and materials and obtained National Health Service ethical approval and research and development governance assurance; HVRS was responsible for project management, data collection and analysis; HVRS and DAR developed the UK Morita Therapy outpatient protocol; DAR supervised the study therapists. HVRS drafted the manuscript. All other authors contributed to editing of the final manuscript. All authors read and approved the final manuscript.
Funding The first author (HVRS) had a PhD fellowship award from the University of Exeter Medical School; DAR and JF are also funded by the University of Exeter Medical School and DAR, as a National Institute for Health Research Senior Investigator, receives additional support from the UK National Institute for Health Research South West Peninsula Collaboration for Leadership in Applied Health Research and Care. The AccEPT Clinic is funded by the National Health Service Northern, Eastern and Western Devon Clinical Commissioning Group and hosted by the University of Exeter’s Mood Disorders Centre. The Morita Trial was sponsored by the University of Exeter (contact details available on request). The sponsor and funding sources have had no role in the design of this study, nor during its execution, analyses, interpretation of data, or submission of results.
Competing interests None declared.
Patient consent Not required.
Ethics approval National Research Ethics Service South West – Frenchay (reference 15/SW/0103).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The data sets generated and/or analysed during the current study are available from the corresponding author on reasonable request.