1. The future of CBT in Psychosis: Improving Social Recovery and developments in Early Psychosis David Fowler d.fowler@uea.ac.uk

2. The future for CBT in people with psychosis We need different types of CBT to address different targets: CBT for psychotic symptoms: effective for the treatment resistant subgroup but not universally. We need to clarify suitability, readiness for therapy. (Garety et al, 2008; Dunn et al; In prep) At risk Mental States. Can CBT in the prodrome have a preventative impact on psychosis, distress and social outcome? EDIE trial (Morrison, Bentall, Birchwood, Gumley, Jones, Fowler, Dunn) Improving Social Recovery. Can we target social recovery directly as a primary target. Which types of strategies are required? Can we integrate CBT with supported employment, asertive case management. ISREP study. Social Anxiety and emotional disorders. Can approaches we know to be effective in other disorders be used to address these symptoms in people with psychosis? EI SARC.

3. What is the evidence for CBT for Psychosis?

4. Mean Weighted Effect Size No. of StudiesSample Size Target Symptom0.400331964 Positive Symptoms0.372321918 Negative Symptoms0.437231268 Functioning0.37815867 Mood0.36315953 Hopelessness-0.1904431 Social Anxiety0.353261 Outcomes of CBT for Psychosis Effect sizes (Wykes et al 2007)

5. Issue date: March 2009 NICE clinical guideline 82 Developed by the National Collaborating Centre for Mental Health Schizophrenia Core interventions in the treatment and management of schizophrenia in adults in primary and secondary care This is an update of NICE clinical guideline 1 www.nice.org.uk

6. NICE CBTp meta-analysis Summary Robust small to medium effects (≈0.2-0.4 standardised mean difference) on: 1.Total and positive symptoms up to 12 months post treatment 2.Depression 3.Social functioning –some evidence 4.Hallucinations – on specific measures 5.But not consistent evidence for delusions (0.18 smd, n.s.)

7. CBTp: the evidence  Two recent meta-analyses show robust effects on symptoms  Evidence of effects on relapse or rehospitalisation, and functioning  But effect sizes are modest  There is no consistent evidence for delusions

8. Psychological treatments - not quasi-neuroleptics  More akin to surgery than medicine - therapist competence may powerfully affect treatment outcomes (Shafran et al, 2009)  Alliance and active therapy engagement are essential – but difficult for many  Should target a range of specific problems informed by cognitive and psycho-social models– not just psychotic symptoms; but also emotional processes and distress (Birchwood and Trower 2006)

9. 0.10.20.512510 Favours TreatmentFavours Control Emerging evidence of subgroup differences in CBT for psychosis Kuipers 1997 Garety 2008 NCP Garety 2008 CP Lewis 2002 N Turkington 2002 England 2007 Lewis 2002 M Lewis 2002 L Granholm 2005 Jenner 2004 Test for overall effect: Z = 3.13 (P = 0.002)

10. SoCRATES study: evidence of subgroup differences in CBTp  SoCRATES (Lewis et al 2002) study: centre effects were marked.  New analysis found differences in treatment engagement and therapeutic alliance associated with differences in outcome; concluded they were probable sources of the treatment effect heterogeneity (Dunn and Bentall, 2007)

12. PRP trial: evidence of subgroup differences in CBTp  PRP (Garety et al 2008): no main effect of CBTp on primary outcomes of relapse and symptoms, only an effect on depression at 24 months;  Trial was also designed to examine therapist competence, therapy delivery, and patient engagement  Therapy was generally highly competent and fully adherent (90% of all tapes)  We hypothesised differences in outcome related to delivery of no, partial or full therapy

13. PRP trial: ‘The effective elements of CBT for psychosis’ (Dunn, Fowler, Rollinson et al, submitted) 1019 therapy session tapes from 102 participants rated and allocated to: 1.No or minimal therapy: 5 or fewer sessions 2.Partial therapy: Engagement and assessment techniques rated as consistently present 3.Full therapy: Engagement and assessment and/or Active therapy rated as consistently present across all sessions Two factors (Engagement and assessment and Active therapy) derived from factor analysis of R-CTPAS (Rollinson et al, 2008) Both full and partial therapy were highly competently delivered; but partial therapy lacked a number of effectively delivered active therapy techniques

14. Statistical modelling of an ITT effect amongst subgroups in a trial (CACE)  Compare CBT subgroups with identified levels of therapy: no, partial, full  With outcomes in control group where membership of the subgroups is not identified; but is estimated by modelling, using same baseline variables which predict subgroup membership in CBT group  Principal stratification analysis  Model subjected to a variety of sensitivity analyses to test robustness of findings

15. PANSS total: Estimated ITT differences between treatment group and TAU on mean change scores at 24 months (95% CI) by level of therapy * P<0.05 *

16. PANSS positive: Estimated ITT effects - mean change scores - at 24 months between treatment group and TAU (95% CI) by level of therapy * P<0.05 *

17. BDI: Estimated mean ITT effects at 24 months between treatment group and TAU (95% CI) by level of therapy * P<0.05 *

18. Estimated ITT effects on Months in remission between treatment group and TAU by level of therapy * * P<0.05

19. PRP analysis of effect of delivery of type of therapy (Dunn Fowler, Rollinson et al, submitted)  New analyses suggest outcome is related to delivery ‘no’, ‘partial’ or ‘full therapy’, with large and consistent effects on symptoms and months in remission in those who received ‘full’ therapy  Full treatment brings additional 8 months in remission compared to the control group and 12-16 point advantage on PANSS total score  These findings remain significant with multiple sensitivity tests  BUT  Only 40% had ‘full’ therapy (note quality not quantity of sessions) – engagement in therapy is a particular issue for CBTp  Some suggestion of a small detrimental effect (ns) of partial therapy

20. Clinical Implications Therapy works for those amongst whom therapists can deliver the more active therapy procedures Persisting trying to deliver therapy without succesfully moving to active techniques provides little benefit

21. What should be the primary target in CBT for Psychosis? Disability Symptoms

22. EI services improve social outcomes Fowler et al (2010) Early Intervention in Psychiatry) 54% of cohort receiving full EI service were engaged in meaningful part time or full time education or employment compared to 15% of historical controls receiving generic CMHT services Symptomatic outcomes similar to treatment groups from EI trials (e.g. Craig et al, 2004; Nordentoft et al, 2005) Social outcome comparison: EPPIC (McGorry et al, 2004) 50% Lombardy, Italy (Cocchi et al 2004) 40% Denmark (Nordentoft et al, 2004) 34% London (Garety et al, 2005) 36% London (Major et al In Press) 50%

23. Time Use Survey Modified ONS tool to make suitable for use in psychosis Detailed structured interview assessing: –Work history –Current employment, education, voluntary work –Leisure, sports, hobbies, socialising –Chores, childcare Provides good insight into all aspects of time use –Social recovery does not just mean work! Meaningful – hours per week

24. Problems at the recovery stage “I still feel ill” “Something’s wrong with me” “I’m not quite right” “I feel different to before” “Im fine” “Im ok” “don’t want help” “just want to get on with my life” Amotivation Depression and loss of hope Drug abuse social anxiety, social avoidance and withdrawal Schizotypal symptoms: anomalies of experience, voices and paranoia NB: These problems are often missed in people who may be described as doing ok

25. The case for Social Recovery oriented CBT in early psychosis We need a new treatment which promotes social opportunities focussing on promoting hope, positive possible and future selves, and self esteem while managing social anxiety and paranoia. The key may be a combination of cognitive behavioural techniques (e.g. cognitive restructuring, behavioural experiments) with assertive outreach case management (e.g. supported employment; critical time intervention)

26. Social brain, emotional processing and social recovery Social recovery in people with psychosis may be limited by social cognition abilities but is often mediated day to day by ongoing emotional processing Emotional processing: Negative emotional processing (extreme negative thoughts self and others, underpinning processing of danger and vulnerability in a social context) Positive emotional processing (hope, motivation, positive thoughts about self and others, possible selves)

27. Improving Social Recovery in Psychosis (ISREP): A randomised treatment trial of Social Recovery oriented CBT (Fowler et al, Psych Med 2009; Barton et al, Schiz Res, Online) David Fowler, Jo Hodgekins, Michelle Painter, Tony Reilly, Patrick Wymbs, Carolyn Crane, Iain Macmillan, Miranda Mugford, Tim Croudace, Peter Jones. University of East Anglia and Norfolk Early Intervention team University of Cambridge and CAMEO Funded by the Medical Research Council Supported by Eastern Region MHRN d.fowler@uea.ac.uk j.hodgekins@uea.ac.uk

28. SRCBT approach Validates the reality of barriers to recovery Acknowledges the adverse circumstances experienced by people in delayed social recovery Fosters self-image as ‘hero’ in active struggle, develops positive view of self and future Formulates specific individual goals and barriers to social recovery, and pathways to change Works “in vivo” promoting change in activity Encourages behavioural tests to establish positive sense of self and personal agency

29. Draws on repertoire of specific cognitive behavioural strategies used to address social recovery: Negative symptoms: testing expectation of feelings of lack of pleasure or mastery in social situations Social anxiety/paranoia: overcoming avoidance in response to worries about social appraisals using specific targeted behavioural experiments Schizotypal symptoms: decreases catastrophising appraisals about relapse associated with minor psychotic experiences

30. ISREP (MRC funded trial platform study) Grantholders: Fowler, Jones, Macmillan, Mugford Inclusion criteria: People with psychosis early in episode with delayed social recovery problems (unemployed within 8 years of onset of psychosis with a history of failed social recovery interventions e.g. supported employment) Excluding >PANSS 4 psychosis Norfolk and Cambridge Centres N=77 recruited 35 treatment 42 controls Assessed at baseline and 9mths Pilot – feasibility and effect sizes

31. Active TAU control condition Treatment as usual: active social recovery keyworking and supported employment Social recovery interventions provided by keyworkers (mean 15 sessions) 10% supported employment keyworkers 23% vol sector keyworkers 50% NHS case managers 3% Self help groups

32. Assessments Primary outcome: Time use (Weekly hours in structured activity adapted from ONS) Secondary outcomes: Hopelessness (BHI), Depression (BDI), PANSS Mediators: Positive and negative beliefs about self and others (BCSS), Paranoia, social anxiety ((SSI)

33. ISREP hypotheses 1.ISREP strategies would lead to an increase in structured and economic activity and hope, without an increase in psychosis 2.People with affective psychosis may have better overall recovery than non-affective psychosis 3.Activity gains will be mediated by positive beliefs about self and others and social anxiety

34. Eligible referrals N = 200 Randomised N = 77 SRCBT N = 35 TAU N = 42 9mth N = 33 9mth N = 38 2yrs N = 29 2yrs N = 37 Allocation Post- intervention Follow-up Lost to follow-up N = 4 Lost to follow-up N = 1 Lost to follow-up N = 2 Lost to follow-up N = 4

35. Demographics Control (N = 42) Treatment (N = 35) Mean Age in yrs (SD)29.95 (7.15)27.80 (6.12) Gender (%) - Male - Female 30 (71.4%) 12 (28.6%) 25 (71.4%) 10 (28.6%) Diagnosis (%) - Non-Affective - Affective 27 (64.3%) 15 (35.7%) 23 (65.7%) 12 (34.3%) Mean illness length in yrs (SD) 4.8 (2.4)4.9 (2.2) Mean unemployment length in wks (SD) 214.8 (209.2)202.4 (146.0)

36. Findings – Combined affective and non-affective sample Hypothesis 1: ISREP strategies would lead to an increase in structured and economic activity and hope without an increase in psychosis Treatment group had mean unit gain of 5.5 hours per week over and above TAU (CI -5.6 – 16 hrs) –Effect size of 0.2 Health economic analysis showed gains to be cost effective below the £20000 per QALY level (EQol- 5D) Significant effects on positive beliefs about self

37. Mean difference in Positive Beliefs about Self (T2-T1) between Control and Treatment groups for whole sample

38. Mean difference in Positive Beliefs about Others (T2-T1) between Control and Treatment groups for whole sample

39. Findings – Differential effect of affective vs non-affective psychosis Hypothesis 2: Affective psychosis may have better overall recovery than non-affective psychosis Affective sample seem to have better outcome in general, regardless of intervention –Consistent with our previous findings in EI (Macmillan et al, Early Intervention, 2007) SRCBT had a more specific effect amongst the non-affective sample

41. Mean difference in time spend in Structured Activity (T2-T1) between Control and Treatment groups for non-affective sample

42. Mean difference in Hopelessness (T2-T1) between Control and Treatment groups for non-affective sample

43. Mean difference in PANSS Total (T2-T1) between Control and Treatment groups for the non-affective sample

44. ISREP findings on employment at 2 year follow up in combined group (affective and non-affective psychosis ) 32% CBT vs 17% controls engaged in paid work at 2 years. CBt group had mean 98.2 hours (SD 233) versus controls 31.2 hours (SD 92) in work. Effect size = 0.41.

45. ISREP findings on employment in non- affective psychosis group at 2 years 26% of people with non affective psychosis in CBT group had worked compared to none (0%) in control group Those in CBT group had worked mean 43 hours (SD 95) Effect size 0.45

46. Can we improve social recovery in psychosis? It looks promising !! Focussing on social recovery in cases with complex delayed recovery syndromes may be an effective strategy Thanks for listening

47. Early Psychosis Social Anxiety Research Clinic (SARC) Fowler, Gega, Hodgekins, Mackintosh, Turner, Hoppitt NIHR RISC Pilot trial of CBT for social anxiety in early psychosis using graduate level mental health workers following standard CBT manuals (n=50) Early findings are interesting showing possibilities of important gains from short term treatments focussing on behavioural experiments Also exploring the development of computer based methods of delivery (psychoeducation, cognitive bias modification training, virtual environments)

48. Thankyou for listening….