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
Alsubaie M., Dickens C., Dunn BD., Gibson A., Ukoumunne OC., Evans A., Vicary R., Gandhi M., Kuyken W.
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 comorbid depression and cardiovascular disorders. A three-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 3 months following the intervention. Those in the adapted-MBCT arm additionally underwent a qualitative interview to gather their views about the adapted intervention. Three thousand four hundred potentially eligible participants were approached when attending an outpatient appointment at a cardiology clinic or via a GP letter following a case note search. Two hundred forty-two (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, 7 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 Patient Health Questionnaire (PHQ)-9 scores for the MBCT-Heart and Living Mindfully (HeLM) group were lower at post-intervention and at the 3-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 (1 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.