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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

Title: 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
Authors: Barnhofer, T; Dunn, BD; Strauss, C; Ruths, F; Barrett, B; Ryan, M; Ladwa, A; Stafford, F; Fichera, R; Baber, H; McGuinness, A; Metcalfe, I; Harding, D; Walker, S; Ganguli, P; Rhodes, S; Young, A; Warren, F
Publisher Information: BioMed Central
Publication Year: 2026
Collection: Oxford University Research Archive (ORA)
Description: Background: Non-remission after psychological therapy for major depressive disorder is common, yet there are no established further-line treatments. In the UK National Health Service (NHS) Talking Therapies programme, about 50% of patients with depression who come to the end of the stepped care pathway do not show remission of symptoms. We aimed to investigate whether mindfulness-based cognitive therapy (MBCT) can improve clinical outcomes and whether the additional financial cost is worthwhile. Methods: We conducted a parallel, randomised, controlled, superiority trial in three sites in the UK (Devon, London, and Sussex). Patients with current major depressive disorder whose symptoms had not reached remission (assessed as Patient Health Questionnaire-9 [PHQ-9] score ≥10) after an adequate dose of NHS Talking Therapies high-intensity therapy (≥12 sessions) were recruited from 20 NHS Talking Therapies services. Participants were allocated through remote random assignment (1:1) to MBCT plus treatment as usual or treatment as usual alone at the UK Clinical Research Collaboration-registered Exeter Clinical Trials Unit with minimisation on depression severity (PHQ-9 score
Document Type: article in journal/newspaper
Language: English
DOI: 10.1186/s13063-022-06882-w
Availability: https://doi.org/10.1186/s13063-022-06882-w; https://ora.ox.ac.uk/objects/uuid:271b2290-bae3-4e1c-a4a2-b85ee6abaaf4
Rights: info:eu-repo/semantics/openAccess ; CC Attribution (CC BY)
Accession Number: edsbas.5CACD197
Database: BASE