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

Journal Article
Kuyken, Modi Alsubaie & Chris Dickens & Barnaby D. Dunn & Andy Gibson & Obioha C. Ukoumunne & Alison Evans & Rachael Vicary & Manish Gandhi & Willem . 2018
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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 depressionand cardiovascular disorders. A three-arm feasibility randomisedcontrolledtrial was conducted, comparing MBCTadapted for peoplewithcardiovasculardisorders plustreatment as usual (TAU), mindfulness-based stress reduction(MBSR)plusTAUandTAUalone.Participantscompletedasetofself-reportmeasuresofdepressionseverity,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 interviewtogathertheirviewsabouttheadaptedintervention.Threethousandfourhundredpotentiallyeligibleparticipantswere approachedwhen attending anoutpatientappointment ata cardiologyclinicor via a GPletter following a casenotesearch. 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 reportedcurrentdepressionorhadahistoryofdepressionandthetimesincetheonsetofcardiovasculardisorders(1to25years). Theadapted-MBCTinterventionwasfeasibleandacceptabletoparticipants;however,certainaspectsofthetrialdesignwerenot. 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 interventionwas unlikely to be well tailored to all the participants needs.Thissuggeststhat ifthe decisionismadetomovetoa definitivetrial,study recruitment procedures will need to be revised to recruit a target sample that optimally matches the adapted intervention.