1. Staying well after depression (SWAD) CI Professor Mark Williams PI Professor Ian Russell Sholto Radford Research Officer s.radford@bangor.ac.uk

2. Depression a prevalent Condition Risk of recurrence 90% for individuals with 3 or more previous episodes. Suicide ideation is one of the most consistently recurring symptoms of depression. 80% of suicide would not occur without depression. Mindfulness-Based Cognitive Therapy (MBCT) is a promising approach to preventing relapse. Depression and suicide

3. MBCT for preventing relapse 3 centre study (Teasdale et al, 2000) Single centre replication study (Ma & Teasdale, 2004) Summary of results of both trials: MBCT approximately halved (70% to 39%) the likelihood of depressive relapse in patients who had had three of more episodes of depression MBCT now recommended by NICE as a treatment for prevention of depression.

4. MBCT vs Antidepressants (ADs) 123 patients with a history of recurrent depression MBCT (with or without ADs) was equal if not slightly better at preventing relapse than maintenance antidepressant treatment alone, and better at improving quality of life. MBCT is more expensive than maintenance ADs in first 12 mths; then MBCT becomes more cost effective (Kuyken et al 2008)

5. Research questions MBCT - effective relapse prevention of major depression and incidence of suicidal symptoms. Comparison with equally plausible treatment without meditation (CPE) “dismantling”. Understand potential moderators and mediators of treatment outcome.

6. Design Multi centre trial (Bangor Oxford) RCT – Participants randomised to three conditions:- Treatment as usual (TAU) Mindfulness-Based Cognitive Therapy (MBCT) + TAU Cognitive Psycho Education (CPE) + TAU Stratification - Centre, cohort, history of suicidality (none, ideation, attempt), antidepressants in past 7 days

7. Interventions Both 8 week courses, 2 hour sessions, 2 MBCT – manualised treatment combines training in mindfulness with cognitive therapy – 1 hour per day home practice (meditation + smaller tasks to cultivate mindfulness. CPE – Includes all elements of MBCT except experiential cultivation of mindfulness. Learn psychological process involved in relapse, mood monitoring, disengaging from unhelpful patterns of processing.

8. Assessment Assessment – treatment effects monitored Pre intervention T0, Post intervention T1, 3 months T2, six months T3, nine months T4, twelve months T5. Blind assessors – SCID + battery of questionnaires and cognitive tasks

9. Sample and recruitment Using 2:2:1 ratio – 5% significance level 300 participants 99% power for detection of difference CPE –MBCT with 20% attrition 375 target. Referral – advertisements in community, clinics + GP surgeries, referral from GP’s and mental health clinicians, talks a t professional meetings. Preliminary phone screening - recruiters Detailed assessment (SCID) - assessors

10. Inclusion criteriaExclusion criteria Age 18 - 70History of, schizophrenia, Schizoaffective disorder, Bipolar 1, current severe substance abuse, primary diagnosis of OCD or eating disorder, regular self harm. DSM-IV criteria major depression >3 episodes (2 in past 5 years 1 in past 2 years Positive continuing response to CBT NIMH guidelines for recovery (1 week in past 8 of core symptom or suicidal feelings + 1 other symptom. Psychotherapy of counselling more than once per month. Giving informed consent + Consent from GP Cannot complete baseline assessment

11. Participants randomised n = 274 did not attend at least one follow up n =19 VariableBreakdown GenderFemale =198 (72%) Male =76 (28%) Age FemaleMean = 42.40 Minimum = 18 Maximum = 68 Age MaleMean = 46.12 Minimum = 18 Maximum 66 Antidepressants used at baseline No = 154 (56%) Yes 120 ( 44%) Suicidality – historyNone = 53 (20%) Ideation =138 (50%) Attempt =83 (30%) Number of previous episodes MDD (n= 240) Mean = 7 Minimum = 3 Maximum =45

12. Analysis Intention to treat analysis (ITT) Primary outcome – time to relapse or recurrence of MDD in weeks. Continuous quantitative measure of outcome also used (HRSD) for severity and to strengthen the dichotomised outcome. Other quantitative measures used include BDI-II, BHS,BSS, EQ5D. Secondary outcome- recurrence of suicidal ideation. Firstly - in participants who relapse Secondly - severity of suicidal symptoms for all participants Beck scale for suicide ideation (BSS) + MINNI suicide-tracking measure Thirdly – suicidal cognitions between groups with AnCova. T1 and T5 with T0 as covariate

13. Mediation Assessing cognitive measures Mindfulness, suppression, self compassion, rumination, autobiographical memory and executive capacity Regression on both the dichotomous outcome (binary logisitc) of relapse and on worst HRSD score (linear) during follow up.

14. Summary Recurrent depression is common and serious particularly for those who become suicidal when depressed. Urgent need to develop treatments that produce sustainable reductions in risk of recurrence And to identify the critical therapeutic factors to refine the approach for the future