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

Impact of Psychoeducation and Coping Impact of Psychoeducation and Coping on Compliance and Course of the Illness on Compliance and Course of the Illness in Patients with Depressionin Patients with Depression

Subproject 6.7: A. Schaub Subproject 6.7: A. Schaub E. Roth, U. Goldmann, M.Charypar, B. BehrendtE. Roth, U. Goldmann, M.Charypar, B. Behrendt

Department of Psychiatry, Department of Psychiatry, Ludwig-Maximilian-University of MunichLudwig-Maximilian-University of Munich

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

Design of the randomised controlled study (Schaub et al., 2003)Design of the randomised controlled study (Schaub et al., 2003)

All patients,

who meet

inclusion criteria

Clinical Management (CM)

CM + 12 + 4 Psychoeduca-

tional-Cognitive Group sessions

(PEC-G)

Follow-up Assess-ments: 6, 12,

18 and 24 months

Randomisation

Pre-assessment

Post-assessment

CM + 12 + 4 Psychoeduca-

tional-Cognitive Group sessions

16 Individual Sessions(PEC-GI)

++

Inclusion criteriaInclusion criteria

• Diagnosis: Depressive Episode (F32) or Recurrent Depression (F33)• Aged 18 to 69 years• Sufficiently stable and motivated to attend group sessions twice a weekSufficiently stable and motivated to attend group sessions twice a week plus

if necessary 16 individual sessions• Sufficiently stable and motivated to participate at diagnostic assessmentsSufficiently 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

Exclusion criteriaExclusion criteria

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

Assessment instrumentsAssessment 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)

Psychoeducational cognitive group to cope with Psychoeducational cognitive group to cope with depression (PEC) (Schaub 2000)depression (PEC) (Schaub 2000)

1. – 3. session Psychoeducation 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?

BehaviourBehaviour ThoughtsThoughts

MoodMood

01.09.0201.03.03

01.09.0301.03.04

01.09.0401.09.9901.03.00

01.09.0001.03.01

01.09.0101.03.02

Pilot StudyN = 53 Center I, Munich

N = 177N = 13

Subproject 6.7: Time Schedule

Calculated Sample Size: N = 218

Center II, Homburg

N = 41

Study design: status quo in the first study center Study design: status quo in the first study center

N=359N=359

N=177N=177

PEC-GIPEC-GI

invited for invited for 6-months 6-months follow upfollow up

N=60N=60

N=47N=47

ScreeningScreening

Patients includedPatients included

N=59N=59

N=46N=46

N=58N=58

N=45N=45

PEC-GPEC-GCMCM

N=35N=35 N=36N=36 N=37N=37invited for invited for 1-year 1-year follow upfollow up

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 15,9No outpatient therapy possible (residence, time) 35 19,2Not stable enough for intervention group 10 5,5Other intervention study 4 2,2other 21 11,5

Total 182 100

Drop-out after randomisation (postassessment, N = 177)Drop-out after randomisation (postassessment, N = 177)

Drop-out rate: 24,9% (n = 44)Drop-out rate: 24,9% (n = 44)

Intervention Intervention CM CM PEC-G PEC-G PEC-GI PEC-GI

nn % % n n % % nn % %

Drop outsDrop outs 13 13 22,8 22,8 12 12 20,0 20,0 1919 31,7 31,7

Drop-out after randomisation (six month follow-up, N = 177)Drop-out after randomisation (six month follow-up, N = 177)

Drop-out rate: 26,0% (n = 46)Drop-out rate: 26,0% (n = 46)

Intervention Intervention CM CM PEC-G PEC-G PEC-GI PEC-GI

nn % % n n % % nn % %

Drop outsDrop outs 14 14 24,6 24,6 13 13 21,7 21,7 1919 31,7 31,7

of these: of these: refused further participation,refused further participation,asking for more treatment (CM) asking for more treatment (CM) 66 had more individual treatment (CM)had more individual treatment (CM) 22 no motivation, no time, too muchno motivation, no time, too much (PEC-GI)(PEC-GI) 99change in diagnosis (all groups) change in diagnosis (all groups) 7 7

Description of the Munich sample (n = 177Description of the Munich sample (n = 177))

MM SD SD Age at index hospitalization (years) Age at index hospitalization (years) 47,9747,97 12,64 12,64 Duration of illness (years)Duration of illness (years) 9,88 10,60 9,88 10,60 Number of hospitalizations Number of hospitalizations 2,16 2,30 2,16 2,30 Total length of hospitalizations (monthsTotal length of hospitalizations (months) 2,97 2,97 7,34 7,34 Current duration of hospitalization before 3,62 4,09 Current duration of hospitalization before 3,62 4,09 study recruitment (weeks)study recruitment (weeks)

MADRSMADRS 21,89 8,4421,89 8,44HAMDHAMD 21,04 8,09 21,04 8,09 BDIBDI 23,55 11,20 23,55 11,20

Diagnosis ICD-10: Diagnosis ICD-10: F 32 depressive episode 51,1% F 32 depressive episode 51,1% F 33 recurrent depression F 33 recurrent depression 48,9%48,9%

Sex:Sex: women 55,9% women 55,9% men 44,1%men 44,1%

Description of the Homburg sample (n = 41Description of the Homburg sample (n = 41))

MM SD SD Age at index hospitalization (years) Age at index hospitalization (years) 51,8051,80 9,54 9,54 Duration of illness (years)Duration of illness (years) 12,68 11,28 12,68 11,28 Number of hospitalizations Number of hospitalizations 2,73 2,08 2,73 2,08 Total length of hospitalizations (monthsTotal length of hospitalizations (months) 3,61 3,61 3,21 3,21 Current duration of hospitalization before 3,28 2,84 Current duration of hospitalization before 3,28 2,84 study recruitment (weeks)study recruitment (weeks)

MADRSMADRS 26,39 8,8926,39 8,89HAMDHAMD 19,73 7,70 19,73 7,70 BDIBDI 26,94 11,35 26,94 11,35

Diagnosis ICD-10: Diagnosis ICD-10: F 32 depressive episode 24,4% F 32 depressive episode 24,4% F 33 recurrent depression F 33 recurrent depression 75,6%75,6%

Sex:Sex: women 58,5% women 58,5% men 38,7%men 38,7%

Feedback questionnaire for the psychoeducational-cognitive group treatment (n = 61)

Helpful Informative Applicable Increasingconfidence

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notlittledistinctvery much

Rey Auditory Verbal Learning Test as Predictor for Rey Auditory Verbal Learning Test as Predictor for Symptom Improvement Part ISymptom Improvement Part I

Scale: right answers in recall (20 minutes)Scale: right answers in recall (20 minutes)Group: Group: Patients Patients belowbelow Median Median, Treatment Takers only, Treatment Takers onlyNo significant differences in T1, regarding treatment conditionsNo significant differences in T1, regarding treatment conditions

MANOVA Symptoms T1 to T3, MANOVA Symptoms T1 to T3, Time x Group BDI Time x Group BDI N=43 p=0,808N=43 p=0,808Time x Group MADRS Time x Group MADRS N=37 p=0,688N=37 p=0,688Time x Group HAMD Time x Group HAMD N=42 p=0,981N=42 p=0,981

The scale does not predict symptom improvement in either of the treatment The scale does not predict symptom improvement in either of the treatment conditions.conditions.

Rey Auditory Verbal Learning Test as Predictor for Rey Auditory Verbal Learning Test as Predictor for Symptom Improvement Part IISymptom Improvement Part II

Scale: right answers in recall (20 minutes)Scale: right answers in recall (20 minutes)Group: Group: Patients Patients aboveabove Median Median, Treatment Takers only, Treatment Takers only

MANOVA Symptoms T1 to T3, MANOVA Symptoms T1 to T3, Time x Group BDI Time x Group BDI N=33 p=0,697N=33 p=0,697Time x Group MADRS Time x Group MADRS N=33 p=0,102N=33 p=0,102Time x Group HAMD Time x Group HAMD N=34 p=0,151N=34 p=0,151

The scale does not predict symptom improvement in either of the treatment The scale does not predict symptom improvement in either of the treatment conditions.conditions.

Research experiencesResearch experiences

• Possible gap in medical care:Possible gap in medical care:The time after hospital discharge seems to be the most sensitive period for The time after hospital discharge seems to be the most sensitive period for relapse; careful preparation and continuity of treatment are essen-tial and relapse; careful preparation and continuity of treatment are essen-tial and should always be provided (someone should be in charge for the patient).should always be provided (someone should be in charge for the patient).

• Cognitive interventions:Cognitive interventions:These seem to be less useful for patients who show „concretistic“ ways of 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 thinking: some patients seem not to be able to reflect their own behavior in terms of underlying dysfunctional patterns and name them. terms of underlying dysfunctional patterns and name them.

• • Dissemination effectsDissemination effectsThe team of the ward specialised on depression felt the need to offer a “low 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-dose” psychoeducational group for all patients and asked for help for imple-mentation.mentation.

Treatment at six month follow-upTreatment at six month follow-up

GroupGroup CMCM PEC-GPEC-G PEC-GIPEC-GI

Meeting theMeeting the 84,2%84,2% 95%95% 96,4%96,4%psychiatristpsychiatrist

IndividualIndividual 15,8%15,8% 50%*50%* 70,4%70,4%TherapyTherapy

* Increased need for psychotherapy in the mere group intervention.* Increased need for psychotherapy in the mere group intervention.

Preliminary results (n = 68) at six month follow-upPreliminary results (n = 68) at six month follow-up

• The response rates are different in the three treatment The response rates are different in the three treatment conditions: conditions:

CM: CM: 50% 50% PEC-G: PEC-G: 39,3%39,3%PEC-GI: PEC-GI: 81,3% 81,3%

• The rehospitalisation rate (intent to treat) is not different:The rehospitalisation rate (intent to treat) is not different:

CM: CM: 16,7%16,7%PEC-G:PEC-G: 15,0%15,0%PEC-GI:PEC-GI: 18,5%18,5%

Summary of preliminary dataSummary of preliminary data

218 patients were included in the psychoeducational-cognitive treatment study. 218 patients were included in the psychoeducational-cognitive treatment study.

There were no significant treatment gains neither in symptoms nor psychologicalThere were no significant treatment gains neither in symptoms nor psychologicalvariables between experimental and control group from pre- to postassessment.variables between experimental and control group from pre- to postassessment.

Drop-out rate: highest in clinical management as well as combination of group Drop-out rate: highest in clinical management as well as combination of group and individual treatmentand individual treatment

The majority of patients rates the group intervention as helpful.The majority of patients rates the group intervention as helpful.

The level of neuropsychological functioning (AVLT, VFT) was not predictive for The level of neuropsychological functioning (AVLT, VFT) was not predictive for treatment gains in different treatment strategies. Research on illness concepts treatment gains in different treatment strategies. Research on illness concepts and treatment expectations is still in progress. and treatment expectations is still in progress.

The main outcome criteria is relapse rate. Completing one year follow-up will be The main outcome criteria is relapse rate. Completing one year follow-up will be due next year.due next year.

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

SustainabilitySustainability

supported by the Federal Ministry of Education and Research supported by the Federal Ministry of Education and Research within the competence-network „depression, suicidality“ and 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

Acknowledgement

Treatment plan of the PECTreatment plan of the PEC

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 Relapseprevention

        Pharmacological and psychosocial interventions   Emergency plan   Dealing with the illness in social contacts

13 -16 Boostersessions

       Support to transfer these contents in daily living   Exchange of participants‘ experiences