A randomised controlled trial to investigate the clinical effectiveness and cost effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) for depressed non-responders to Increasing Access to Psychological Therapies (IAPT) high-intensity therapies: study protocol
Trials January 19, 2023 T. Barnhofer, B. Dunn, C. Strauss et al.
This paper describes a planned randomized controlled trial testing whether Mindfulness-Based Cognitive Therapy (MBCT), added to treatment as usual, reduces depression symptoms more than treatment as usual alone in patients who have not responded to at least 12 sessions of high-intensity psychological therapy through England's Increasing Access to Psychological Therapies (IAPT) services. The trial will enroll patients meeting criteria for major depressive disorder, randomizing them to MBCT plus usual care or usual care alone. Assessments occur at baseline, 10 weeks, and 34 weeks post-randomization. The primary outcome is depression symptom reduction at 34 weeks measured by the PHQ-9. Cost-effectiveness will also be evaluated.