Mindfulness-Based Cognitive Therapy for IAPT Treatment Non-Responders
Research type
Research Study
Full 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
IRAS ID
281532
Contact name
Thorsten Barnhofer
Contact email
Sponsor organisation
Sussex Partnership NHS Foundation Trust
ISRCTN Number
ISRCTN17755571
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Summary of Research
If not treated sufficiently, Major Depression tends to take a recurrent or chronic lifetime course that is associated with a significantly increased risk for physical and neurodegenerative disorders. IAPT services provide evidence-based treatment for patients with common mental disorder with an access rate intended to rise to 25% of this population by 2021. However, about 50% of the depressed patients who come to the end of this pathway, have not responded sufficiently.
Our research will investigate whether Mindfulness-Based Cognitive Therapy (MBCT), a group-based treatment combining intensive training in mindfulness meditation and cognitive therapy, can effectively reduce symptoms and lead to sustained recovery in patients suffering from Major Depressive Disorder who have not sufficiently responded to high-intensity evidence-based therapy and have thus come to the end of the Increasing Access to Psychological Therapies (IAPT) care pathway. It will also test whether the introduction of this treatment can reduce subsequent service use.
We will randomly allocate 234 patients who have not sufficiently responded to IAPT high-intensity therapy to take part either in MBCT, delivered via videoconferencing, or to continue with TAU in a three-centre (London, Exeter, Sussex) RCT. Reductions in depression symptomatology will be assessed using the Patient Health Questionnaire-9, a standard measure of the severity of depression used in IAPT treatment-monitoring, at 10-week (secondary outcome) and 34-week follow-up post-randomisation (primary outcome). Service-use information will be collected using the Adults Service Use Schedule.Other secondary outcomes will include severity of anxiety symptoms, mental wellbeing, adjustment and psychological process variables such as mindfulness, self-compassion and decentering.
Potential participants will be invited to one of the research sites to determine eligibility using clinical interviews and questionnaires. Eligible participants either receive an eight-week course of MBCT or continue with their treatment as usual. Follow-up assessments will be conducted remotely using online questionnaires. Anticipated total duration of the project is 24 months with start of recruitment into the trial planned for the 1st of March 2021.
Summary of Results
Patients were chosen by chance to participate in MBCT or continue with their usual care. We assessed changes in patients’ symptoms directly after the end of the treatment and 6 months thereafter. We also gathered information on patients’ use of health services to see whether, and to what degree, MBCT delivers value for money. A group of 234 eligible patients participated. MBCT was offered to 118 while 116 were asked to continue withtheir usual treatment. Those who had received MBCT reported less symptoms 6 months after the end of treatment. We also found MBCT to be worthwhile in terms of costs. The findings suggest that MBCT is effective, can be introduced at reasonable cost and
should be made available for patients who have not improved in NHS Talking Therapies services.
Results will be published on the trial registry once the main trial paper is published.
REC name
West of Scotland REC 4
REC reference
20/WS/0177
Date of REC Opinion
18 Jan 2021
REC opinion
Further Information Favourable Opinion