Mindfulness-Based Cognitive Therapy for Depressed IAPT Non-Responders

NCT05236959 | Unknown DMC

• 1 other identifier: NIHR200750
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 4

Brief Summary

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. In England, Increasing Access to Psychological Therapies (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. Mindfulness-Based Cognitive Therapy, a treatment combining training in mindfulness meditation and components from cognitive therapy, has previously been shown to be effective in treatment non-responders, but further evidence is needed to establish this finding more definitively and to see whether positive effects can be achieved within the stepped care approach of IAPT. In order to address these issues, this study will investigate whether MBCT 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. The investigators will randomly allocate 234 patients who have not sufficiently responded to IAPT high-intensity therapy to take part either in MBCT 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. If successful, the current project would provide the necessary evidence base for the introduction of MBCT for IAPT high-intensity non-responders.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire-9 (PHQ-9) at 34-weeks post-randomisation

  Depressive symptomatology at 34-weeks post-randomisation as assessed using the Patient Health Questionnaire-9 (PHQ-9). Scores on the PHQ-9 can range from 0 to 27 with higher scores indicating more severe depression.

  34 weeks post-randomisation

Secondary Outcomes (8)

• Patient Health Questionnaire-9 (PHQ-) at 10-weeks post-randomisation

  10 weeks post-randomisation

• A series of binarised outcomes based on PHQ-9 and GAD-7

  34 weeks post-randomisation

• Generalized Anxiety Disorder Questionnaire (GAD-7)

  10 weeks and 34 weeks post-randomisation

• Phobia Scale

  10 weeks and 34 weeks post-randomisation

• Work and Social Adjustment Scale

  10 weeks and 34 weeks post-randomisation

Other Outcomes (2)

• Adult Service Use Schedule (AD-SUS)

  10 weeks and 34 weeks post-randomisation

• EQ-5D-5L

  10 weeks and 34 weeks post-randomisation

Study Arms (2)

Mindfulness-Based Cognitive Therapy

EXPERIMENTAL

A group-based treatment combining intensive training in mindfulness mediation and elements of cognitive therapy (see further above).

Behavioral: Mindfulness-Based Cognitive Therapy

Treatment as Usual

OTHER

Participants in this group continue with their usual care and follow the regimes suggested by their GP or mental health professionals (see further above).

Other: Treatment as Usual

Interventions

Mindfulness-Based Cognitive Therapy BEHAVIORAL

Following an initial interview session, patients are offered eight weekly group-based session, delivered via videoconferencing, and asked to engage in regular daily home practice of mindfulness meditation

Also known as: MBCT

Mindfulness-Based Cognitive Therapy

Treatment as Usual OTHER

Following an initial interview session, patients continue with their usual care

Also known as: TAU

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non-response to a minimal effective dose of high intensity treatment in IAPT (at least 12 sessions, in line with NICE draft guideline suggestions) defined in line with the caseness threshold adopted by IAPT as a Patient Health Questionnaire-9 (PHQ-9) score of 10 or higher
• meeting criteria for a current episode of Major Depression according to DSM-5 as assessed through the Mini International Neuropsychiatric Interview for DSM-5
• age 18 or older
• access to a working internet connection to participate in videoconferencing assessments and interventions
• Potential participants will be excluded if
• based on the judgment of their IAPT therapist they are eligible for, would be seen by, and their needs would be best met by secondary care specialist services
• they present with a level of risk to self or others that cannot be safely managed in a primary care service context (i.e. active suicidal plans), a history of psychosis or psychotic symptoms, a current episode of mania, alcohol or substance abuse or dependence within the past 3 months, current post-traumatic stress disorder, obsessive-compulsive disorder or eating disorder.
• they suffer from any other significant disease or disorder that may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
• if they have an insufficient ability to understand or read English.
• Patients who are currently taking antidepressant medication will be allowed into the trial and medication use will be documented for statistical analysis.

Sponsors & Collaborators

• Sussex Partnership NHS Foundation Trust: lead
• King's College London: collaborator
• University of Exeter: collaborator

Study Sites (4)

Mood Disorders Centre, University of Exeter

Exeter, Devon, United Kingdom

RECRUITING

Sussex Partnership NHS Foundation Trust

Brighton, Sussex, United Kingdom

RECRUITING

Devon Partnership NHS Trust

Exeter, United Kingdom

RECRUITING

South London and Maudsley NHS Foundation Trust

London, United Kingdom

RECRUITING

Related Publications (6)

• Moylan S, Maes M, Wray NR, Berk M. The neuroprogressive nature of major depressive disorder: pathways to disease evolution and resistance, and therapeutic implications. Mol Psychiatry. 2013 May;18(5):595-606. doi: 10.1038/mp.2012.33. Epub 2012 Apr 24.

  PMID: 22525486 BACKGROUND

• Teasdale JD, Segal ZV, Williams JM, Ridgeway VA, Soulsby JM, Lau MA. Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. J Consult Clin Psychol. 2000 Aug;68(4):615-23. doi: 10.1037//0022-006x.68.4.615.

  PMID: 10965637 BACKGROUND

• Barnhofer T, Crane C, Hargus E, Amarasinghe M, Winder R, Williams JM. Mindfulness-based cognitive therapy as a treatment for chronic depression: A preliminary study. Behav Res Ther. 2009 May;47(5):366-73. doi: 10.1016/j.brat.2009.01.019. Epub 2009 Feb 5.

  PMID: 19249017 BACKGROUND

• van Aalderen JR, Donders AR, Giommi F, Spinhoven P, Barendregt HP, Speckens AE. The efficacy of mindfulness-based cognitive therapy in recurrent depressed patients with and without a current depressive episode: a randomized controlled trial. Psychol Med. 2012 May;42(5):989-1001. doi: 10.1017/S0033291711002054. Epub 2011 Oct 3.

  PMID: 22017808 BACKGROUND

• Eisendrath SJ, Gillung E, Delucchi KL, Segal ZV, Nelson JC, McInnes LA, Mathalon DH, Feldman MD. A Randomized Controlled Trial of Mindfulness-Based Cognitive Therapy for Treatment-Resistant Depression. Psychother Psychosom. 2016;85(2):99-110. doi: 10.1159/000442260. Epub 2016 Jan 26.

  PMID: 26808973 BACKGROUND

• 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. 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. 2023 Jan 19;24(1):43. doi: 10.1186/s13063-022-06882-w.

  PMID: 36658663 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Mindfulness-Based Cognitive Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Thorsten Barnhofer, PhD

  University of Surrey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah Baber

CONTACT

01392 722700; hannah.baber@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Use of remote assessments, initiated through automated email, will rule out any potential effects of assessors on assessments of outcomes. The statisticians will remain blind to treatment allocation throughout the analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled trial with two arms and three sites

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: February 11, 2022
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Upon publication of results
• Access Criteria: Scientists of good standing with approved projects as assessed by internal review

Locations

GB (4)