Evidence base of schema therapy current studies and challenges. Klaus Lieb, Jutta Stoffers-Winterling

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1 Evidence base of schema therapy current studies and challenges Klaus Lieb, Jutta Stoffers-Winterling Universitätsmedizin Mainz, Germany

2 13. Auflage Nov Ca. 39,99 Euro Most important slides will be available from: unter Klinische Partner/Veranstaltungen

3 Agenda What does evidence-based psychotherapy mean? What are the effects of SFT in the treatment of borderline personality disorder/other disorders? Conclusions and recommendations for research and treatment

4 Efficacy and effectiveness Efficacy studies: homogeneous samples Randomised controlled trials (RCTs) Randomised treatment allocation Control group (TAU, waiting list, alternate treatment) (blinding) SR/meta-analyses Study sample Population efficacy effectiveness implementation consumer interersts costs and benefits Effectiveness studies: reallife health care settings 4

5 Effect sizes: SMDs = standardised mean differences Effect estimates 0.2: small 0.5: moderate 0.8: large

6 Conflicts of interest in psychotherapy: risk of bias Royalties for talks, courses and seminars Researcher allegiance Publication bias Lieb et al., BMJ Open 2016; Lieb et al.,

7 Declarations of conflicts of interest K. Lieb Since 2007 no payments or other gratifications from the pharmaceutical industry Cooperation with the pharmaceutical industrie in conducting clinical studies via the clinic research centre ( ): Kendle Inc., Essex, Norgine, Lilly, Pfizer, Novartis and Hoffmann La Roche (DRM-Konten)

8 Declarations of conflicts of interest K. Lieb (ctd.) Cognitive behaviour therapy, schema-focused therapy Chair of the Committee on Transparency and Independence of the Arzneimittelkommission der dt. Ärzteschaft (AkdÄ) ; founding member of MEZIS e.v. ( no free lunch )

9 Agenda What does evidence-based psychotherapy mean? What are the effects of SFT in the treatment of borderline personality disorder/other disorders? Conclusions and recommendations for research and treatment

10 SR RCTs cohort studies case control studies case series, case reports editorials, expert opinion Klinik für Psychiatrie und 10

11 Evidence of SFT in Borderline Personality Disorder 11

12 Stoffers et al. 2012: DBT and SFT in BPD (SMDs) BPD severity affective impulsiv e interperso nel cognitiv general functioni ning drop-outs DBT anger suicid. depress RR parasuic anxiety (vs. CTBE) I-SFT vs TFP (pro SFT) RR 0.52 (pro SFT) G-SFT group vs. WL RR 0.11 Stoffers et al.,

13 N=52 BPD patients 1 year of SFT- and DBT-based psychoeducational group integrated into available individual therapy (CTBE) vs. TAU BPD symptoms and overall severity did not differ sig. at post-treatment, but sig. difference for health-related QoL 13

14 international multicentre trial (NL, D, AUS, US, UK, G) Study sample calculation: N= 448 men and women with BPD GSFT vs. GFST+ISFT vs. TAU observation period: 24 months outcomes: BPDSI-IV, BSI, GAF, SOFAS, WSAS, WHOQOL 14

15 Evidence of SFT in mixed PDs 15

16 SFT vs. clarification-oriented PT (COPT) vs. TAU (May 2006 January 2011) PD: Cluster C (mostly), paranoid, histrionic, narcissistic 50 indiv. sessions (40 during first year, 10 booster sessions during second year) 624 Pat. screened, 323 Pat. randomised (SFT: N=147; TAU: N=135, COPT: N=41) Primary outcome: recovery-rate at 3 years Bamelis et al.,

17 Bamelis et al. 2014: findings Klinik für Psychiatrie und Smallest drop-out rate in SFT Highest recovery rate in SFT at 3 years 17

18 Preliminary findings of ongoing RCT N=30 male, forensic patients with PDs (87% aspd, 30%BPD) 3 years of inpatient ST vs. TAU No sig. post-treatment group differences, though a tendency of better outcomes (recidivism risk, re-entry into society as measured in time up to first unsupervised leave) in the ST group 18

19 n=8 patients (mostly avoidant PD and comorbid axis-i disorders) 20 sessions, 2 drop-outs, no control large pre-post effects for avoidant PD severity, depression, anxiety n=4 didn t meet criteria for their respective PD at post-treatment, n=5 at follow-up n=6 didn t meet criteria for depression at post-treatment and 6 months follow-up clinically significant effects on GSI. adaptive modes, maladaptive modes at follow-up Skewes et al.,

20 N=35 patients, 79% with any PD, 25% BPD 12 months of inpatient ST in treatment non-responders (3 months of conventional treatment; primarily mood disorders, SUD) Sig. pre-post changes on general psychopathology, overall mental health; also ST-specific outcomes ( Changes mostly maintained at 6-months follow-up 20

21 Schema Therapy in axis I disorders 21

22 N = 100 outpatients with MDD SFT vs. CBT 6 months weekly, 6 months monthly sessions Response: at least 60% amelioration on MADRS Remission: MADRS < 10 and BDI-II < 13 for 2 weeks Recovery: MADRS < 10 and BDI-II < 13 for 8 weeks Baseline, 6 and 12 months 22

23 Carter et al. 2013: No differences between SFT and CBT No sig. post-treatment group differences (MADRS, BDI-II) Pre-post effect sizes at post-treamtent: (MADRS), 0.08 (BDI-II), no difference between groups Responders: SFT 46%, CBT: 52%, n.s. Remission: SFT 50%, CBT 40%, n.s. Recovery: ST 56%, CBT 50%, n.s. at post-treatment Patients with and without PD did not differ significantly in MADRS change Both treatments seem to have similar effects SFT may be an alternate treatment option to CBT 23

24 N=25 patients with chronic (>2 years) major depressive disorder, 68% with comorbid PD Multiple baseline single case series 6-24 weeks no treatment baseline 12 weeks exploration/attention control phase up to 65 sessions IST Large sig. effects on depressive pathology 67% recovery (absence of depression diagnosis) 35% remission (mean BDI score 6 or lower), 24

25 N=12 patients with chronic depression A-B-C design 8 weeks WL sessions introduction to ST and bonding to therapist up to 60 sessions (including introductory sessions) 16% response (50% reduction on HRDS + HRDS score between 8 and 15) 42% remission (HRDS 8 or less) 25

26 RCT N=112 women with transdiagnostic binge eating SFT versus CBT versus CBT/appetite focus (transdiagnostic binge eating 6 months weekly followed by 6 months monthly sessions Large pre-post effects of eating disorder symptoms in all groups No sig. differences between groups at post-treatment 26

27 N=10 patients with OCD who failed to respond to CBT ST plus exposure and response prevention (STERP) 12-week inpatient programme: 3 weeks introduction 6 weeks change phase 3 weeks final phase sig. pre-post effects on OCD symptoms, depression and overlal functioning 27

28 Agenda What does evidence-based psychotherapy mean? What are the effects of SFT in the treatment of borderline personality disorder/other disorders? Conclusions and recommendations for research and treatment

29 Summary Schema therapy in (B)PD I Klinik für Psychiatrie und Evidence is not robust, additional studies are necessary Psychotherapy trials are prone to allegiance bias No dismantling studies so far (except from SFT vs. SFT+therapist telephone availability, with no sif. effects) 29

30 Summary Schema therapy in (B)PD II DBT has a far more robust evidence base than SFT in BPD: Klinik für Psychiatrie und Cautious conclusion: try DBT first, then other approaches like SFT RCT of DBT vs. SFT is timely and necessary As of yet, there is no evidence on a certain sequence of therapies (future research is needed) Results of the study of Wetzelaer, Arntz and colleagues will be essential Individual vs. group SFT First comparison of SFT to TAU in BPD at all 30

31 Summary Schema therapy in axis-i disorders Chronic depression: large pre-post effects (2 case series); but no sig. difference if compared to CBT (1 RCT) Eating disorders (binge eating): no sig. post-treatment group effects as compared to CBT and CBT with appetite focus (1 RCT) Obsessive-compulsive disorder: pre-post effects on OCD, PD pathology, depression and functioning (1 case series) 31