Mindfulness-based cognitive therapy (MBCT) versus the health-enhancement program (HEP) for adults with treatment-resistant depression: a randomized control trial study protocol
Stuart J. Eisendrath, Erin P Gillung, Kevin L. Delucchi, M. Chartier, Daniel H. Mathalon, J. Sullivan, Z. Segal, Mitchell D. Feldman
BMC Complementary and Alternative Medicine March 11, 2014 DOI: 10.1186/1472-6882-14-95 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Peer reviewed |
|---|---|
| Population | Adults age 18 and older with moderate to severe treatment-resistant depression who failed to respond to at least two trials of antidepressants in the current episode |
| Interventions | Mindfulness-Based Cognitive Therapy Health-Enhancement Program |
| Duration | 8-week intervention, 1-year follow-up |
| Topics | Depression Meditation |
| Registration | NCT01021254 |
| Key findings | MBCT as an augmentation to antidepressants was compared to HEP for adults with treatment-resistant depression; primary outcomes were change in depression severity, treatment response, and remission after 8 weeks. |
Abstract
BackgroundMajor depressive disorder (MDD) is the leading cause of disability in the developed world, yet broadly effective treatments remain elusive. Up to 40% of patients with depression are unresponsive to at least two trials of antidepressant medication and thus have “treatment-resistant depression” (TRD). There is an urgent need for cost-effective, non-pharmacologic, evidence-based treatments for TRD. Mindfulness-Based Cognitive Therapy (MBCT) is an effective treatment for relapse prevention and residual depression in major depression, but has not been previously studied in patients with TRD in a large randomized trial.Methods/DesignThe purpose of this study was to evaluate whether MBCT is an effective augmentation of antidepressants for adults with MDD who failed to respond to standard pharmacotherapy. MBCT was compared to an active control condition, the Health-Enhancement Program (HEP), which incorporates physical activity, functional movement, music therapy and nutritional advice. HEP was designed as a comparator condition for mindfulness-based interventions to control for non-specific effects. Originally investigated in a non-clinical sample to promote stress reduction, HEP was adapted for a depressed population for this study. Individuals age 18 and older with moderate to severe TRD, who failed to respond to at least two trials of antidepressants in the current episode, were recruited to participate. All participants were taking antidepressants (Treatment as usual; TAU) at the time of enrollment. After signing an informed consent, participants were randomly assigned to either MBCT or HEP condition. Participants were followed for 1 year and assessed at weeks 1–7, 8, 24, 36, and 52. Change in depression severity, rate of treatment response and remission after 8 weeks were the primary outcomes measured by the clinician-rated Hamilton Depression Severity Rating (HAM-D) 17-item scale. The participant-rated Quick Inventory of Depression Symptomology (QIDS-SR) 16-item scale was the secondary outcome measure of depression severity, response, and remission.DiscussionTreatment-resistant depression entails significant morbidity and has few effective treatments. We studied the effect of augmenting antidepressant medication with MBCT, compared with a HEP control, for patients with TRD. Analyses will focus on clinician and patient assessment of depression, participants’ clinical global impression change, employment and social functioning scores and quality of life and satisfaction ratings.Trial registrationClincalTrials.gov identifier: NCT01021254
Comparable studies
Other randomized controlled trials on depression, most cited first.
Citations in the library
Cited by 17
- Mindfulness meditation–based pain relief: a mechanistic account Annals of the New York Academy of Sciences June 1, 2016
- A Randomized Controlled Trial of Mindfulness-Based Cognitive Therapy for Treatment-Resistant Depression Psychotherapy and Psychosomatics 2016
- Meditation for Major Depressive Disorder: A Systematic Review RAND Corporation eBooks 2015
- Evaluation of major depressive disorder using 7 Tesla phase sensitive neuroimaging before and after mindfulness-based cognitive therapy. Journal of Affective Disorders August 15, 2023
- Group Mindfulness-Integrated Cognitive Behavior Therapy (MiCBT) Reduces Depression and Anxiety and Improves Flourishing in a Transdiagnostic Primary Care Sample Compared to Treatment-as-Usual: A Randomized Controlled Trial. Frontiers in Psychiatry May 31, 2022
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Cites 11
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- Mindfulness training as a clinical intervention: A conceptual and empirical review. Clinical Psychology Science and Practice 2003
- Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Journal of Consulting and Clinical Psychology 2000
- Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Journal of Consulting and Clinical Psychology 2004
- Mindfulness-based cognitive therapy for depression August 21, 2006
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