TY - JOUR
T1 - 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
T2 - study protocol
AU - Barnhofer, Thorsten
AU - Dunn, Barnaby D.
AU - Strauss, Clara
AU - Ruths, Florian
AU - Barrett, Barbara
AU - Ryan, Mary
AU - Ladwa, Asha
AU - Stafford, Frances
AU - Fichera, Roberta
AU - Baber, Hannah
AU - McGuinness, Ailis
AU - Metcalfe, Isabella
AU - Harding, Delilah
AU - Walker, Sarah
AU - Ganguli, Poushali
AU - Rhodes, Shelley
AU - Young, Allan
AU - Warren, Fiona
N1 - Funding Information:
This trial is funded through the Research for Patient Benefit (RfPB) Programme of the National Institute for Health Research (NIHR), Central Commissioning Facility, Grange House, 15 Church Street, Twickenham TW1 3NL in the UK. The funders’ number for this trial is NIHR200750. The views expressed here are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.
Funding Information:
The authors are grateful to Dr Bernadette Egan, Research Design Service South East, for helpful advice on the design of this trial. The study is sponsored by Sussex Partnership NHS Foundation Trust, Sussex Education Centre, Nevill Avenue, Hove, BN3 7HY.
Publisher Copyright:
© 2023, The Author(s).
PY - 2023/1/19
Y1 - 2023/1/19
N2 - Background: Major depression represents a pressing challenge for health care. In England, Increasing Access to Psychological Therapies (IAPT) services provide evidence-based psychological therapies in a stepped-care approach to patients with depression. While introduction of these services has successfully increased access to therapy, estimates suggest that about 50% of depressed patients who have come to the end of the IAPT pathway still show significant levels of symptoms. This study will investigate whether Mindfulness-Based Cognitive Therapy (MBCT), a group intervention combining training in mindfulness meditation and elements from cognitive therapy, can have beneficial effects in depressed patients who have not responded to high-intensity therapy in IAPT. It will seek to establish the effectiveness and cost-effectiveness of MBCT as compared to the treatment these patients would usually receive. Methods: In a 2-arm randomised controlled trial, patients who currently meet the criteria for major depressive disorder and who have not sufficiently responded to at least 12 sessions of IAPT high-intensity therapy will be allocated, at a ratio of 1:1, to receive either MBCT (in addition to treatment as usual [TAU]) or continue with TAU only. Assessments will take place at baseline, 10 weeks and 34 weeks post-randomisation. The primary outcome will be reduction in depression symptomatology 34 weeks post-randomisation as assessed using the Public Health Questionnaire-9 (PHQ-9). Secondary outcomes will include depressive symptomatology at 10 weeks post-randomisation and other clinical outcomes measured at 10-week and 34-week follow-up, along with a series of binarised outcomes to indicate clinically significant and reliable change. Evaluations of cost-effectiveness will be based on assessments of service use costs collected using the Adult Service Use Schedule and health utilities derived from the EQ-5D. Discussion: This trial will add to the evidence base for the use of MBCT in depressed treatment non-responders. It will constitute the first trial to test MBCT following non-response to psychological therapy, with results providing a direct estimate of efficacy within the IAPT pathway. As such, its results will offer an important basis for decisions regarding the adoption of MBCT for non-responders within IAPT. Trial registration: ClinicalTrials.gov NCT05236959. Registered on 11 February 2022. ISRCTN 17755571. Registered on 2 February 2021.
AB - Background: Major depression represents a pressing challenge for health care. In England, Increasing Access to Psychological Therapies (IAPT) services provide evidence-based psychological therapies in a stepped-care approach to patients with depression. While introduction of these services has successfully increased access to therapy, estimates suggest that about 50% of depressed patients who have come to the end of the IAPT pathway still show significant levels of symptoms. This study will investigate whether Mindfulness-Based Cognitive Therapy (MBCT), a group intervention combining training in mindfulness meditation and elements from cognitive therapy, can have beneficial effects in depressed patients who have not responded to high-intensity therapy in IAPT. It will seek to establish the effectiveness and cost-effectiveness of MBCT as compared to the treatment these patients would usually receive. Methods: In a 2-arm randomised controlled trial, patients who currently meet the criteria for major depressive disorder and who have not sufficiently responded to at least 12 sessions of IAPT high-intensity therapy will be allocated, at a ratio of 1:1, to receive either MBCT (in addition to treatment as usual [TAU]) or continue with TAU only. Assessments will take place at baseline, 10 weeks and 34 weeks post-randomisation. The primary outcome will be reduction in depression symptomatology 34 weeks post-randomisation as assessed using the Public Health Questionnaire-9 (PHQ-9). Secondary outcomes will include depressive symptomatology at 10 weeks post-randomisation and other clinical outcomes measured at 10-week and 34-week follow-up, along with a series of binarised outcomes to indicate clinically significant and reliable change. Evaluations of cost-effectiveness will be based on assessments of service use costs collected using the Adult Service Use Schedule and health utilities derived from the EQ-5D. Discussion: This trial will add to the evidence base for the use of MBCT in depressed treatment non-responders. It will constitute the first trial to test MBCT following non-response to psychological therapy, with results providing a direct estimate of efficacy within the IAPT pathway. As such, its results will offer an important basis for decisions regarding the adoption of MBCT for non-responders within IAPT. Trial registration: ClinicalTrials.gov NCT05236959. Registered on 11 February 2022. ISRCTN 17755571. Registered on 2 February 2021.
KW - Increasing Access for Psychological Therapies (IAPT)
KW - Major depressive disorder
KW - Mindfulness-Based Cognitive Therapy
KW - Treatment non-response
UR - http://www.scopus.com/inward/record.url?scp=85146586339&partnerID=8YFLogxK
U2 - 10.1186/s13063-022-06882-w
DO - 10.1186/s13063-022-06882-w
M3 - Article
C2 - 36658663
AN - SCOPUS:85146586339
SN - 1745-6215
VL - 24
JO - Trials
JF - Trials
IS - 1
M1 - 43
ER -
