Mindfulness Based Cognitive Therapy for Depressed Patients with Coronary Heart Disease:

1. Mindfulness Based Cognitive Therapy for Depressed Patients with Coronary Heart Disease: Results of a Controlled Trial James O. O’Neill UCD, RCSI & Connolly Hospital Siobhan Dinan Tallaght Hospital Ian Graham TCD & Tallaght Hospital Vincent Maher TCD & Tallaght Hospital Veronica O’Doherty UCD and Tallaght Hospital Alan Carr UCD Alison McGrann Connolly Hospital

2. AIM • The aim of the study was to evaluate the effectiveness of mindfulness based cognitive therapy (MBCT) for treating depression in coronary heart disease (CHD) patients

3. Mindfulness Based Cognitive Therapy • Mindfulness Based Cognitive Therapy was developed by Zindel Segal, Mark Williams and John Teasdale. • It is described in the treatment manual • Mindfulness Based Cognitive Therapy for Depression • and a self-help book • The Mindful Way Through Depression Zindel Segal Mark Williams John Teasdale

4. Mindfulness Based Stress Reduction • MBCT is based on CBT and Jon Kabat Zinn’s Mindfulness-Based Stress Reduction (MBSR) programme which is described in his book • Full Catastrophe Living Jon Kabat Zinn

5. Evidence for the Effectiveness of Mindfulness-Based Interventions • Meta-analyses show that MBCT prevents relapse in chronic recurring depression (e.g., Piet and Hougaard, 2011) • Meta-analyses show that mindfulness-based programmes (including MBCT & MBSR) lead to improvements in symptoms of depression and anxiety in a wide range of mental health problems (e.g., Klainin-Yobas et al., 2012)and chronic medical conditions (e.g., Bohlmeijer et al., 2010)

6. Previous Studies of Mindfulness Based Interventions for CHD Patients • Three studies of mindfulness-based interventions for CHD patients have been published • Sullivan et al. (2009) in a trial involving 208 CHD patients found that compared to a control group MBSR led to improvements in depression, anxiety, and cardiac symptoms at 12 months follow-up. • Tacon et al., (2003) in a pilot of 20 female CHD patients found that compared to a control group, MBSR led to improvements in anxiety, the tendency to supress negative emotion, and the tendency to cope reactively or impulsively with stresses • Griffiths et al., (2009) in a qualitative study of depressed CHD patients’ experiences of MBCT, found that the development of awareness, commitment, within-group experiences, relating to the material and acceptance as central experiential themes

7. Tallaght Hospital • The MBCT programme evaluated in our study was run between March 2007 and October 2011at the Psychology Department of Tallaght Hospital, also known as the Adelaide & Meath Hospital Incorporating the National Children’s Hospital. This is a major university teaching hospital in west Dublin, Ireland

8. Design • This was a controlled trial in which 32 consecutive depressed CHD patients were assigned to an MBCT treatment group and 30 similar cases were consecutively assigned to a waiting-list control group • They were assessed at baseline (Time 1), 8 weeks later (Time 2) and at 6 months follow-up (Time 3) • A power analysis showed that a trial completer sample size of 60 (30 cases in each of two trial arms) was required for this study in order for statistical tests with a p value of .05 and a power value of .80 to be able to detect moderate intergroup differences • Participants had a hospital diagnosis of CHD and met the criteria for a current DSM IV major depressive episode assessed with the SCID • Cases under 18 with other major psychological or physical disorders, or CHD patients in other psychosocial interventions were excluded

9. Design Design MBCT Treatment Group N=32 Waiting List Control Group N=30 Time 1 Assessment Baseline Time 1 Assessment Baseline MINDFULNESS BASED COGNITIVE THERAPY NO PSYCHOSOCIAL TREATMENT Time 2 Assessment 8 weeks later Time 2 Assessment 8 weeks later Time 3 Assessment 6 months later Time 3 Assessment 6 months later

10. Dropouts • The dropout rate from the trial was 47% • 62 of 117 cases that entered the trial completed assessments at Times 1,2 and 3. • Trial completers and dropouts had similar profiles, so completers were probably representative of all cases who entered the trial • The next diagram shows the flow of cases through the study

11. Flow of Patients Through the Study

12. Group differences at Time 1 • At Time 1, trial completers in the treatment and control groups were very similar on demographic and clinical variables • Baseline differences were unlikely to account for the large improvements shown by the treatment group compared with the control group at Times 2 and 3 • At Time 1, treatment and control groups did not differ significantly in terms of gender distribution, age, socioeconomic status, number of children, and psychological adjustment as assessed by the HADS, BSI, and POMS. • At Time 1, the treatment group contained more married participants and they showed more problems with health-related quality of life on the PAIS and less mindfulness on the MAAS than the control group. • Ancillary analyses showed these Time 1 differences had negligible effects on outcome at Times 2 and 3

13. Demographic and Clinical characteristics at Time 1

14. Mindfulness Based Cognitive Therapy Group Programme • The MBCT group programme at Tallaght Hospital included 8 consecutive 2-hour weekly sessions, and followed Segal, Williams and Teasdale’s manual • Participants practiced mindfulness meditation exercises, learned how to use these exercises to cope with negative mood states and developed a conceptual understanding of mindfulness meditation and depression, using a CBT framework. • Within this framework, negative mood states are viewed as deriving, not from life events, but from the way a person thinks interprets these events. • From this perspective, negative moods may be altered by acknowledging that negative thoughts about challenging life events and related moods are not facts, but merely transient mental states to which people prone to depression react as if they were objective facts, and it is this that is the proximal cause of low mood

15. Mindfulness Based Cognitive Therapy Group Programme • In the first half of the MBCT group programme participants learned the body scan meditation and the mindfulness of breath meditation • In the second part of the programme participants were helped to identify high-risk situations in which to use meditation as a relapse prevention skill. • Between sessions participants completed daily meditation and mood management homework • They were given audio recordings and hand-outs to guide them through homework • Participants viewed a documentary (Healing from Within) on Jon Kabat Zinn’s (1990) MBSR for chronic pain patients which is described in his book Full Catastrophe Living

16. Mindfulness Based Cognitive Therapy Group Programme • The MBCT group programme was run on 9 occasions and participants attended the programme in groups of 4-7 • 90% (29 participants) completed 5 or more of the 8 MBCT sessions • On each occasion the MBCT group programme was facilitated by an experienced psychologist trained in the MBCT protocol (VO’D), and co-facilitated by an assistant psychologist • All sessions were audio taped and a sample of these was checked against an integrity checklist by two independent raters, who reached 100% agreement on session the integrity checklist

17. Assessment Protocol • SCID-D Depression module of the Structured Clinical Interview for DSM-IV • HADS Hospital Anxiety and depression Scale • BSI Brief Symptom Inventory • POMS Profile of Mood States – brief form • PAIS Psychosocial Adjustment to Illness Scale – self report form • MAAS Mindful Attention Awareness Scale • MCSDS Marlow Crowne Social Desirability Scale – short form • CSQ Client Satisfaction Questionnaire • PQ Post-session Questionnaire • All instruments have strong psychometric properties and the HADS, BSI, POMS, PAIS, & MAAS had alphas above .7 and correlations less than .4 with the MCSDS

18. Recruitment and Assessment • Participants were recruited into the trial from cardiology departments at Tallaght and Connolly hospitals • At Times 1, 2 and 3 participants completed the following instruments (which are explained on the previous slide): • SCID-D • HADS • BSI • POMS • PAIS • MAAS • At Time 1 they also competed a demographic questionnaire and the MCSDS • At Time 2 they completed the CSQ • After each session they completed the PQ

19. Clinical Recovery Rate • Cases were classified as clinically recovered from depression at Times 2 and 3 if they if • they no longer met the DSM IV criteria for depression, and • scored below 8 on the HADS depression scale • At Times 2 and 3, the clinical recovery rate in the treatment group was significantly higher than that of the control group

20. 100 90 80 70 60 50 40 30 20 10 0 Clinical Recovery Rates 81% 72% 50% 50% Clinical recovery rate MBCT Waiting List Treatment Control Group Group Time 3 MBCT Waiting List Treatment Control Group Group Time 2

21. Improvements in group means • A series of 2 X 3, Groups X Time, ANOVAs were conducted to examine the effect of treatment and control group membership and change over Times 1, 2 and 3 on HADS, BSI, POMS, PAIS and MAAS mean scores. • To reduce the risk of Type 1 error, the p value for each of these ANOVAs was reduced to .03 using the rough false discovery rate, to keep the study-wise p value at .05 • Statistically significant Group X Time interactions occurred for all dependent variables. • Tests of simple effects showed that, for all variables, the treatment group improved more than the control group • The following graphs show the patterns of improvement in mean scores

22. HADS - Depression 11 10 9 8 7 6 5 0 WL Control Group Clinical cut-off is 8 HADS-Depression MBCT Treatment Group Time 1 Time 2 Time 3

23. 13 12 11 10 9 8 7 6 0 HADS -Anxiety WL Control Group HADS-Anxiety Clinical cut-off is 8 MBCT Treatment Group Time 1 Time 2 Time 3

24. 28 25 22 19 16 13 0 BSI – Global Severity Index WL Control Group 90th Percentile is 20 BSI-Global Severity Index MBCT Treatment Group Time 1 Time 2 Time 3

25. 45 40 35 30 25 20 15 0 POMS – Total Mood Disturbance WL Control Group POMS-Total Mood Disturbance MBCT Treatment Group Time 1 Time 2 Time 3

26. 45 40 35 30 25 20 0 PAIS – Health-Related QoL WL Control Group PAIS-Total Health-Related QoL MBCT Treatment Group Time 1 Time 2 Time 3

27. 4.6 4.4 4.2 4.0 3.8 3.6 3.4 3.2 0 MAAS - Mindfulness MBCT Treatment Group WL Control Group MAAS-Mindfulness Time 1 Time 2 Time 3

28. Effect sizes at Times 2 and 3 • Effect sizes were calculated to indicate the extent of differences between means of treatment and control groups at Times 2 and 3 and are shown on the next slide • At Time 2 we found moderate to large effect sizes ranging from d = 0.60 to 0.82 for • HADS anxiety and depression • POMS total mood disturbance and • MAAS mindful attention scale • At Time 2 we found small effect sizes (d < 0.2) for • BSI global severity index and • PAIS total health-related quality of life • At Time 3 effect sizes for all dependent variables were moderate to large ranging from d = 0.43 to 1.0

29. Effect Sizes on all Dependent Variables HADS - Depression HADS – Anxiety BSI - Global Severity Index POMS - Tot. Mood Disturbance PAIS - Health-Related QoL MAAS - Mindfulness Time 2 effect size Time 3 effect size .1 .2 .3 .4 .5 .6 .7 .8 .9 1.0

30. Correlations between Improvements in Mindfulness and Improvement in Depression & Adjustment • Improvements in mindfulness were correlated with improvements in depression and psychological adjustment • Time 1 to Time 3 difference scores were computed for all dependent variables, for trial completers in treatment and control groups • MAAS mindfulness had the following significant (p<.025) correlations with measures of depression and adjustment • r = 0.27, HADS – Depression • r = 0.34, HADS – Anxiety • r = 0.61, BSI - Global Severity Index • r = 0.55, POMS - Total Mood Disturbance • r = 0.29, PAIS - Health-Related QoL

31. Significant Therapeutic Events and Processes • A thematic content analysis was conducted on statements participants made in the PQ about significant therapeutic events and processes • PQs were completed after each session, so memories of therapy sessions were fresh in participants minds • Themes reflecting 12 significant therapeutic events and process were identified

32. Significant Therapeutic Events and Processes

33. Treatment Satisfaction • On the PQ significant therapeutic events were given a mean helpfulness rating of 5.97 out of 7 (SD = 0.82) indicating that on average they were rated as very helpful • On the PQ therapy sessions were given a mean helpfulness rating of 5.99 out of 7 (SD = 0.88) indicating that on average they were rated as very helpful. • On the 8 questions of the CSQ, 83-96% of participants evaluated the MBCT programme positively at Time 2.

34. Ratings of 23 MBCT Programme Completers on the Client Satisfaction Questionnaire

35. Conclusions • MBCT is an effective treatment for depression in CHD patients • MBCT has no adverse effects • Participants are very satisfied with MBCT • There is an association between increased mindfulness and improvement in depression • Particularly helpful aspects of MBCT include learning meditation, having group support and developing optimism

36. Comparison with other studies • This the first published study of MBCT for CHD patients in which DSM IV major depression was an inclusion criterion • The effect size we found for depressive symptoms of d = 0.77 after treatment and d = 0.60 at six-months follow-up compares very favourably with • the effect size of d = 0.31 found for cognitive behaviour therapy programmes for depressed CHD patients in the meta-analysis by Dickens et al. (2013) • the effect-size of d = 0.33 found for in a major trial of antidepressant medication (citalopram) for depressed CHD patients (Lesperance et al., 2007)

37. Limitations • There was a high dropout rate. • This probably did not lead to attrition bias • Completers and dropouts had similar Time 1 profiles so it may be assumed that trial completers were representative of all cases who entered the trial • Results of an ancillary intent-to-treat analysis with last observation carried forward for dropouts, were consistent with results of the main analyses • Cases were not randomly assigned to groups • This probably did not lead to selection bias • Treatment and control groups had similar Time 1 profiles • Ancillary analyses showed that variables on which treatment and control groups differed at Time 1 (marital status, PAIS and MAAS) had a negligible effects on outcome

38. The Future • A large multi-site randomized controlled trial of MBCT for depression secondary to CHD is now warranted

39. THANK YOU Mindfulness Based Cognitive Therapy for Depressed Patients with Coronary Heart Disease: Results of a Controlled Trial James O’Neill Connolly Hospital Siobhan Dinan Tallaght Hospital Ian Graham TCD & Tallaght Hospital Vincent Maher TCD & Tallaght Hospital Veronica O’Doherty UCD and Tallaght Hospital Alan Carr UCD Alison McGrann Connolly Hospital