Impact of Psychoeducation and Coping on Compliance and Course of the Illness

1. Impact of Psychoeducation and Coping on Compliance and Course of the Illness in Patients with Depression Subproject 6.7: A. Schaub E. Roth, U. Goldmann, M.Charypar, B. Behrendt Department of Psychiatry, Ludwig-Maximilian-University of Munich

2. Randomised controlled studies for Cognitive Behavioural Therapy (CBT), Interpersonal Psychotherapy (IPT) and Psychopharmacotherapy Elkin et al. (1989) - CBT vs. IPT vs. Imipramine + CM vs. Placebo + CM (N=162) - Imipramine + CM > CBT and IPT > Placebo + CM Frank et al. (1990) - Imipramine + CM vs. Imipramine + IPT vs. Placebo + CM vs. IPT vs. Placebo + IPT (N = 106) - Imipramine + CM and Imipramine + IPT > Placebo + IPT > Placebo + CM De Jong-Meyer et al. - Antidepressiva + CBT vs. Antidepressivants + supportive counseling (N=155) (1996) - In both conditions symptoms improved significantly, no signif. differences Hautzinger et al. - CBT vs. Antidepressivants + CBT vs. Antidepressivants + supportive (1996) counseling (N=191); - In both conditions symptoms improved significantly, no significant differences between the conditions Paykel et al. (1999) - Imipramine + CM vs. Imipramine + CM + CBT (N=127) - Significant better results in the combined treatment Keller et al. (2000) - CBAT vs. Nefazodone vs. combination of both (N = 681) - Significant better results in the combined treatment

3. Design of the randomised controlled study (Schaub et al., 2003) Pre- assessment Post- assessment Clinical Management (CM) Follow-up Assess- ments: 6, 12, 18 and 24 months All patients, who meet inclusion criteria CM + 12 + 4 Psychoeduca- tional-Cognitive Group sessions (PEC-G) Randomisation CM + 12 + 4 Psychoeduca- tional-Cognitive Group sessions 16 Individual Sessions (PEC-GI) +

4. Inclusion criteria • Diagnosis: Depressive Episode (F32) or Recurrent Depression (F33) • Aged 18 to 69 years • Sufficiently stable and motivated to attend group sessions twice a week plus • if necessary 16 individual sessions • Sufficiently stable and motivated to participate at diagnostic assessments • Sufficient intellectual abilities and fluent in German • Living in the surroundings of Munich (max. 1h hours drive) • Informed-consent

5. Exclusion criteria • Bipolar disorder • Borderline personality disorder • Compulsive disorder • Substance abuse (except teetotalism for at least six months) • Organic brain syndrome • Fatal diseases • Suicidal attempt within the last two weeks • Participation at another psychotherapy study • Being involved in inpatient psychotherapy

6. Assessment instruments Rating: Hamilton Depression Scale (HAMD) Montgomery Asperg Scale (MADRS) Global Assessment Functioning Scale (GAF) Compliance Scale (CS), Social Adjustment Scale (SAS) Anamnestic and follow-up schedule (incl. quality of life) Self rating: Beck Depression Inventar (BDI) Automatic Thoughts Questionnaire (ATQ) Dysfunctional Attitude Scale (DAS) Subscales of the Frankfurter Selbstkonzept Scales (FSKN) and Freiburg Questionnaire for Coping (FKK) Locus of control with regard to illness and to health (KKG) Eysenck Personality Inventory (EPQ) Medication Adherence Rating Sheet (MARS) Questionnaire about treatment expectation and satisfaction Subjective Attribution of Aetiology in depression (SUD) Knowledge test about depression Cog. Tests: Wisconsin Card Sorting Test (WCST), Trail Making Test (TMT) Verbal Learning Memory Test (VLMT), Verbal Fluency Test (MWTB) Blood level control (no specific pharmacological treatment regime in this study)

7. Psychoeducational cognitive group to cope with depression (PEC) (Schaub 2000) 1. – 3. sessionPsychoeducation about the illness and its treatment Symptoms, aetiology, course of the illness, treatment options 4. – 6. session Activating strategies How can you make a positive impact on your mood by your own behavior? 7. – 10. session Cognitive therapy How can you make a positive impact on your mood by modifying your thoughts? (cognitive restructuring) 11. – 12. session Relapse prevention How can you prevent a relapse by an emergency plan? 13. – 16.session Generalisation How can you implement these strategies in daily living? Mood Behaviour Thoughts

8. N = 41 N = 53 Center II, Homburg Pilot Study 01.03.00 01.03.01 01.03.02 01.03.03 01.03.04 01.09.99 01.09.00 01.09.01 01.09.02 01.09.03 01.09.04 Subproject 6.7: Time Schedule Calculated Sample Size: N = 218 N = 13 N = 177 Center I, Munich

9. N=359 N=177 N=36 N=35 N=47 N=45 N=37 N=46 N=58 N=60 N=59 Study design: status quo in the first study center Screening Patients included PEC-G PEC-GI CM invited for 6-months follow up invited for 1-year follow up

10. Reasons for excluding patients- screening drop-outs (N = 182) • n % • Refusal 70 38,5 • Discharged or transferred 13 7,1 • Not eligible for treatment 99 54,4 • Diagnostical criteria not met 29 15,9 • No outpatient therapy possible (residence, time) 35 19,2 • Not stable enough for intervention group 10 5,5 • Other intervention study 4 2,2 • other 21 11,5 • Total 182 100

11. Drop-out after randomisation (postassessment, N = 177) Drop-out rate: 24,9% (n = 44) Intervention CM PEC-G PEC-GI n % n % n % Drop outs 13 22,8 12 20,0 19 31,7

12. Drop-out after randomisation (six month follow-up, N = 177) Drop-out rate: 26,0% (n = 46) Intervention CM PEC-G PEC-GI n % n % n % Drop outs 14 24,6 13 21,7 19 31,7 of these: refused further participation, asking for more treatment (CM) 6 had more individual treatment (CM) 2 no motivation, no time, too much (PEC-GI) 9 change in diagnosis (all groups) 7

13. Description of the Munich sample (n = 177) Diagnosis ICD-10: F 32 depressive episode 51,1% F 33 recurrent depression 48,9% Sex: women 55,9% men 44,1% M SD Age at index hospitalization (years) 47,97 12,64 Duration of illness (years) 9,88 10,60 Number of hospitalizations 2,16 2,30 Total length of hospitalizations (months) 2,97 7,34 Current duration of hospitalization before 3,62 4,09 study recruitment (weeks) MADRS 21,89 8,44 HAMD 21,04 8,09 BDI 23,55 11,20

14. Description of the Homburg sample (n = 41) Diagnosis ICD-10: F 32 depressive episode 24,4% F 33 recurrent depression 75,6% Sex: women 58,5% men 38,7% M SD Age at index hospitalization (years) 51,80 9,54 Duration of illness (years) 12,68 11,28 Number of hospitalizations 2,73 2,08 Total length of hospitalizations (months) 3,61 3,21 Current duration of hospitalization before 3,28 2,84 study recruitment (weeks) MADRS 26,39 8,89 HAMD 19,73 7,70 BDI 26,94 11,35

15. not little distinct very much Feedback questionnaire for the psychoeducational- cognitive group treatment (n = 61) % Increasing confidence Recommen-dable Helpful Informative Applicable

16. Rey Auditory Verbal Learning Test as Predictor for Symptom Improvement Part I Scale: right answers in recall (20 minutes) Group: Patients below Median, Treatment Takers only No significant differences in T1, regarding treatment conditions MANOVA Symptoms T1 to T3, Time x Group BDI N=43 p=0,808 Time x Group MADRS N=37 p=0,688 Time x Group HAMD N=42 p=0,981 The scale does not predict symptom improvement in either of the treatment conditions.

17. Rey Auditory Verbal Learning Test as Predictor for Symptom Improvement Part II Scale: right answers in recall (20 minutes) Group: Patients above Median, Treatment Takers only MANOVA Symptoms T1 to T3, Time x Group BDI N=33 p=0,697 Time x Group MADRS N=33 p=0,102 Time x Group HAMD N=34 p=0,151 The scale does not predict symptom improvement in either of the treatment conditions.

18. Research experiences • Possible gap in medical care:The time after hospital discharge seems to be the most sensitive period for relapse; careful preparation and continuity of treatment are essen-tial and should always be provided (someone should be in charge for the patient). • Cognitive interventions:These seem to be less useful for patients who show „concretistic“ ways of thinking: some patients seem not to be able to reflect their own behavior in terms of underlying dysfunctional patterns and name them. • • Dissemination effects • The team of the ward specialised on depression felt the need to offer a “low dose” psychoeducational group for all patients and asked for help for imple-mentation.

19. Treatment at six month follow-up Group CM PEC-G PEC-GI Meeting the 84,2% 95% 96,4% psychiatrist Individual 15,8% 50%* 70,4% Therapy * Increased need for psychotherapy in the mere group intervention.

20. Preliminary results (n = 68) at six month follow-up • The response rates are different in the three treatment conditions: CM: 50% PEC-G: 39,3% PEC-GI: 81,3% • The rehospitalisation rate (intent to treat) is not different: • CM: 16,7% PEC-G: 15,0% PEC-GI: 18,5%

21. Summary of preliminary data 218 patients were included in the psychoeducational-cognitive treatment study. There were no significant treatment gains neither in symptoms nor psychological variables between experimental and control group from pre- to postassessment. Drop-out rate: highest in clinical management as well as combination of group and individual treatment The majority of patients rates the group intervention as helpful. The level of neuropsychological functioning (AVLT, VFT) was not predictive for treatment gains in different treatment strategies. Research on illness concepts and treatment expectations is still in progress. The main outcome criteria is relapse rate. Completing one year follow-up will be due next year.

22. Sustainability After finishing the study intervention in August 2003 in Munich the psycho-educational-cognitive group treatment was integrated into the standard care of the clinic. So the intervention is accessible to a greater number of patients now. The intervention was also established in the second study center (Homburg). The project made a contribution to an improved treatment of depression in a psychiatric setting. Its treatment strategies have also been modified to bipolar disorders (to be publised in Hogrefe next year). The work on this manual is in progress. It will include a therapist manual for the group and individual intervention as well as a manual for the group intervention for relatives. There are handouts for patients and family members. Schaub A, Roth E, Goldmann U (in preparation) Cognitive-psychoducational interventions in unipolar depression. Cognitive-behavioral concepts, treatment manual and handbook for patients and relatives. Göttingen: Hogrefe

23. Acknowledgement supported by the Federal Ministry of Education and Research within the competence-network „depression, suicidality“ and SmithKline Beecham S. Amann, T. Baghai, C. Beyer, S. v. Engeström, E. Hoch, M. Jäger, M. Karsten, P. Kümmler, M. Kulzer, P. Mikhaiel, C. Minov, A. Neusser, C. Ott, M. Rosenzweig, U. Schmid, A-K. Schmidt, I. Scholler, C. Schorr, C. Schüle, K. Welsch, B. Wiese, K. Wilke Prof. M. Ackenheil, M. Schwarz

25. Session Modul Contents 1 - 3 Psycho- education ·Symptoms ·Aetiology ·Treatment options 4 - 6 Activation ·Relationship between behaviour and mood ·Planning positive activities ·Balance between requests and positive activities (Self rewarding plans) 7 - 10 Cognitive therapy ·Relationship between thoughts and mood (ABC-Schema) ·Identifying and modifying depressive thoughts ·Identifying depressive dysfunctional beliefs ·Modifying depressive dysfunctional beliefs 11 -12 Relapse prevention ·Pharmacological and psychosocial interventions ·Emergency plan ·Dealing with the illness in social contacts 13 -16 Booster sessions ·Support to transfer these contents in daily living ·Exchange of participants‘ experiences Treatment plan of the PEC