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  • Clara Strauss
    University of Sussex
  • Anna-Marie Bibby-Jones
    R&D Department
  • Fergal Jones
    Canterbury Christ Church University
  • Sarah Byford
    King's College London
  • Margaret Heslin
    King's College London
  • Glenys Parry
    Sheffield University
  • Michael Barkham
    Sheffield University
  • Laura Lea
    Sussex Partnership NHS Foundation Trust
  • Rebecca Crane
  • Richard de Visser
    University of Sussex
  • Amy Arbon
    University Hospitals Sussex NHS Trust
  • Claire Rosten
    University of Brighton
  • Kate Cavanagh
    University of Sussex

IMPORTANCE: 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.

OBJECTIVE: 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 is cost-effective compared with practitioner-supported CBT-SH.

DESIGN, SETTING, AND PARTICIPANTS: 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 between November 24, 2017, and January 31, 2020. The study took place in 10 publicly funded psychological therapy services in England (Improving Access to Psychological Therapies [IAPT]). A total of 600 clients attending IAPT services were assessed for eligibility, and 410 were enrolled. Participants met diagnostic criteria for mild to moderate depression. Data were analyzed from January to October 2021.

INTERVENTIONS: Participants received a copy of either an MBCT-SH or CBT-SH workbook and were offered 6 support sessions with a trained practitioner.

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.

RESULTS: 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 CBT-SH (n = 206; mean [SD] PHQ-9 score, 8.6 [5.5]), with a between-group difference of -1.5 PHQ-9 points (95% CI, -2.6 to -0.4; P = .009; d = -0.36). The probability of MBCT-SH being cost-effective compared with CBT-SH exceeded 95%. However, although between-group effects on secondary outcomes were in the hypothesized direction, they were mostly nonsignificant. Three serious adverse events were reported, all deemed not study related.

CONCLUSIONS AND RELEVANCE: 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 routinely offered to adults in primary care services.

TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN13495752.

Keywords

  • Psychiatry and Mental health
Original languageEnglish
Pages (from-to)415-424
Number of pages10
JournalJAMA psychiatry
Volume80
Issue number5
Early online date22 Mar 2023
DOIs
Publication statusPublished - 1 May 2023

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