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Web-Based Mindfulness-Based Cognitive Therapy for Adults With a History of Depression: Protocol for a Randomized Controlled Trial.

Mohammad Hooshmand Zaferanieh, Lu Shi, Meenu Jindal, Liwei Chen, Lingling Zhang, Snehal Lopes, Karyn Jones, Yucheng Wang, Kinsey Meggett, Cari Beth Walker, Grace Falgoust, Heidi Zinzow

JMIR Research Protocols June 18, 2024 DOI: 10.2196/53966 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Randomized controlled trial Peer reviewed
Sample size 128
Population Adults with current, residual, or chronic depression symptoms
Duration 8-week intervention, 8-week follow-up
Topics Depression Meditation
Keywords Rct Controlled trials Depressive symptoms Distress Mental health Mindfulness-based cognitive therapy Mindfulness-based interventions Psychotherapy Randomized Remote Virtual delivery Depression management: depression
Citations 1
Registration NCT05347719
Key findings The protocol aims to test the feasibility and efficacy of web-delivered MBCT for reducing depression symptoms and psychiatric distress.

Abstract

Depression poses a major threat to public health with an increasing prevalence in the United States. Mindfulness-based interventions, such as mindfulness-based cognitive therapy (MBCT), are effective methods for managing depression symptoms and may help fortify existing efforts to address the current disease burden. The in-person group format of MBCT, however, incurs barriers to care such as expenses, childcare needs, and transportation issues. Alternate delivery modalities such as MBCT delivered via the web can be investigated for their capacity to overcome these barriers and still reduce symptoms of depression with adequate feasibility and efficacy. This study protocol aims to examine the feasibility and efficacy of MBCT delivered via the web for the treatment of depression. To attain study aims, 2 phases will be implemented using a waitlist control design. A total of 128 eligible participants will be randomized into either an 8-week MBCT intervention group plus treatment as usual (MBCT + TAU; group 1) or an 8-week waitlist control group (group 2). In phase I (8 weeks), group 1 will complete the intervention and group 2 will proceed with TAU. In phase II (8 weeks), group 2 will complete the intervention and group 1 will continue with TAU until reaching an 8-week follow-up. TAU may consist of receiving psychotherapy, pharmacotherapy, or combined treatment. Data collection will be completed at baseline, 8 weeks (postintervention for group 1 and preintervention for group 2), and 16 weeks (follow-up for group 1, postintervention for group 2). The primary outcomes will include (1) current, residual, or chronic depression symptoms and (2) psychiatric distress. Secondary outcomes will include perceived stress and facets of mindfulness. The feasibility will be measured by assessing protocol adherence, retention, attendance, and engagement. Finally, the extent of mindfulness self-practice and executive functioning skills will be assessed as mediators of intervention outcomes. This study began screening and recruitment in December 2022. Data collection from the first cohort occurred in January 2023. By November 2023, a total of 30 participants were enrolled out of 224 who received screening. Data analysis began in February 2024, with an approximate publication of results by August 2024. Institutional review board approval took place on September 11, 2019. This trial will contribute to examining mindfulness-based interventions, delivered via the web, for improving current, residual, or chronic depression symptoms. It will (1) address the feasibility of MBCT delivered via the web; (2) contribute evidence regarding MBCT's efficacy in reducing depression symptoms and psychiatric distress; and (3) assess the impact of MBCT on several important secondary outcomes. Findings from this study will develop the understanding of the causal pathways between MBCT delivered via the web and depression symptoms further, elucidating the potential for future larger-scale designs. ClinicalTrials.gov NCT05347719; https://www.clinicaltrials.gov/ct2/show/NCT05347719. DERR1-10.2196/53966.

Comparable studies

Other randomized controlled trials on depression, most cited first.

Study Year Design Participants
A Randomized Trial of an N-methyl-D-aspartate Antagonist in Treatment-Resistant Major Depression Subjects with DSM-IV major depression (treatment resistant) 2006 Randomized, placebo-controlled, double-blind crossover study n = 18
Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients 2000 Randomized controlled trial n = 145
Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial Cancer patients with life-threatening diagnoses and symptoms of depression and/or anxiety 2016 Randomized controlled trial n = 51
Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial Patients with cancer-related anxiety and depression 2016 Double-blind, placebo-controlled, crossover trial n = 29
Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients 2004 Randomized controlled trial n = 73

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