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Feasibility and Acceptability of Mindfulness-based Cognitive Therapy Compared with Mindfulness-based Stress Reduction and Treatment as Usual in People with Depression and Cardiovascular Disorders: a Three-Arm Randomised Controlled Trial

Modi Alsubaie, Chris M Dickens, Barnaby D. Dunn, Andy Gibson, Obioha Chukwunyere Ukoumunne, Alison Evans, Rachael Vicary, Manish J. Gandhi, Willem Kuyken

Mindfulness July 21, 2018 DOI: 10.1007/s12671-018-0999-8 (opens in new tab)

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Study at a glance

AI-extracted from the abstract
Characteristics Feasibility randomized controlled trial Qualitative Peer reviewed
Sample size 33
Population People with comorbid depression and cardiovascular disorders attending a cardiology clinic or identified via GP letter
Duration Assessments immediately before, after, and three months following the intervention
Measures PHQ-9
Topics Depression Meditation
Citations 29
Key findings The adapted mindfulness-based cognitive therapy intervention was feasible and acceptable, with seven of 11 participants completing the full course and positive qualitative feedback, and mean PHQ-9 scores lower at post-intervention and three-month follow-up than in the MBSR and treatment-as-usual groups. However, trial design aspects were problematic: only 33 of 3,400 approached were randomized, withdrawal between screening and randomization was high, and sample heterogeneity suggested the adapted intervention was unlikely to suit all participants.

Abstract

Depression co-occurs in 20 % of people with cardiovascular disorders, can persist for years, and predicts worse physical health outcomes. While psychosocial treatments have been shown to treat acute depression effectively in those with comorbid cardiovascular disorders, to date, there has been no evaluation of approaches aiming to prevent relapse and treat residual depression symptoms in this group. Consequently, the current study aimed to examine the feasibility and acceptability of a randomised controlled trial design evaluating an adapted version of mindfulness-based cognitive therapy (MBCT) designed specifically for people with co-morbid depression and cardiovascular disorders. A 3-arm feasibility randomised controlled trial was conducted, comparing MBCT adapted for people with cardiovascular disorders plus treatment as usual (TAU), mindfulness-based stress reduction (MBSR) plus TAU, and TAU alone. Participants completed a set of self-report measures of depression severity, anxiety, quality of life, illness perceptions, mindfulness, self-compassion and affect and had their blood pressure taken immediately before, after, and three months following the intervention. Those in the adapted-MBCT arm additionally underwent a qualitative interview to gather their views about the adapted intervention. 3,400 potentially eligible participants were approached when attending an outpatient appointment at a cardiology clinic or via a GP letter following a case note search. 242 (7.1 %) were interested in taking part, 59 (1.7 %) were screened as being suitable, and 33 (<1 %) were eventually randomised to the three groups. Of 11 participants randomised to adapted MBCT, seven completed the full course, levels of home mindfulness practice were high, and positive qualitative feedback about the intervention was given. Twenty-nine out of 33 randomised participants completed all the assessment measures at all three-time points. The means PHQ-9 scores for the MBCT-HeLM group were lower at post-intervention and at the three-month follow-up compared to the MBSR and TAU groups. The sample was heterogeneous in terms of whether they reported current depression or had a history of depression and the time since the onset of cardiovascular disorders (one to 25 years). The adapted MBCT intervention was feasible and acceptable to participants, however, certain aspects of the trial design were not. In particular, low recruitment rates were achieved and there was a high withdrawal rate between screening and randomisation. Moreover, the heterogeneity in the sample was high, meaning the adapted intervention was unlikely to be well tailored to all the participants needs. This suggests that if the decision is made to move to a definitive trial, study recruitment procedures will need to be revised to recruit a target sample that optimally matches the adapted intervention.

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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Depression Meditation Anxiety