Transcript n = 177 - Stiftung Deutsche Depressionshilfe

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
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.
(1996)
- Antidepressiva + CBT vs. Antidepressivants + supportive counseling (N=155)
- In both conditions symptoms improved significantly, no signif. differences
Hautzinger et al.
(1996)
- CBT vs. Antidepressivants + CBT vs. Antidepressivants + supportive
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)
Preassessment
Postassessment
Clinical Management
(CM)
All
patients,
who
meet
inclusion
criteria
CM +
Randomisation 12 + 4 Psychoeducational-Cognitive
Group sessions
(PEC-G)
CM +
12 + 4 Psychoeduca- +
tional-Cognitive
Group sessions
Follow-up
Assessments:
6, 12,
18 and 24
months
16 Individual
Sessions
(PEC-GI)
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
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
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),
Verbal Learning Memory Test (VLMT),
Trail Making Test (TMT)
Verbal Fluency Test (MWTB)
Blood level control (no specific pharmacological treatment regime in this study)
Psychoeducational cognitive group to cope with
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?
Mood
Behaviour
Thoughts
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?
Subproject 6.7: Time Schedule
Calculated Sample Size:
N = 218
N = 41
Center II, Homburg
N = 13
N = 53
Pilot Study
N = 177
Center I, Munich
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
Study design: status quo in the first study center
CM
N=58
N=45
N=35
N=359
Screening
N=177
Patients included
PEC-G
N=59
N=46
N=36
PEC-GI
N=60
N=47
N=37
invited for
6-months
follow up
invited for
1-year
follow 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
29
35
10
4
21
15,9
19,2
5,5
2,2
11,5
Diagnostical criteria not met
No outpatient therapy possible (residence, time)
Not stable enough for intervention group
Other intervention study
other
Total
182
100
Drop-out after randomisation (postassessment, N = 177)
Drop-out rate: 24,9% (n = 44)
Intervention
Drop outs
CM
PEC-G
PEC-GI
n
%
n
%
n
%
13
22,8
12
20,0
19
31,7
Drop-out after randomisation (six month follow-up, N = 177)
Drop-out rate: 26,0% (n = 46)
Intervention
Drop outs
CM
PEC-G
PEC-GI
n
%
n
%
n
%
14
24,6
13
21,7
19
31,7
of these:
refused further participation,
asking for more treatment (CM)
had more individual treatment (CM)
no motivation, no time, too much (PEC-GI)
change in diagnosis (all groups)
6
2
9
7
Description of the Munich sample (n = 177)
Diagnosis ICD-10: F 32
F 33
Sex:
depressive episode
recurrent depression
51,1%
48,9%
women 55,9%
men
44,1%
M
SD
Age at index hospitalization (years)
Duration of illness (years)
Number of hospitalizations
Total length of hospitalizations (months)
Current duration of hospitalization before
study recruitment (weeks)
47,97
9,88
2,16
2,97
3,62
12,64
10,60
2,30
7,34
4,09
MADRS
HAMD
BDI
21,89
21,04
23,55
8,44
8,09
11,20
Description of the Homburg sample (n = 41)
Diagnosis ICD-10: F 32
F 33
Sex:
depressive episode
recurrent depression
24,4%
75,6%
women 58,5%
men
38,7%
M
SD
Age at index hospitalization (years)
Duration of illness (years)
Number of hospitalizations
Total length of hospitalizations (months)
Current duration of hospitalization before
study recruitment (weeks)
51,80
12,68
2,73
3,61
3,28
9,54
11,28
2,08
3,21
2,84
MADRS
HAMD
BDI
26,39
19,73
26,94
8,89
7,70
11,35
Feedback questionnaire for the psychoeducationalcognitive group treatment (n = 61)
%
90
80
70
60
50
not
little
distinct
very much
40
30
20
10
0
Helpful
Informative
Applicable
Increasing
confidence
Recommendable
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.
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.
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 implementation.
Treatment at six month follow-up
Group
CM
PEC-G
PEC-GI
Meeting the
psychiatrist
84,2%
95%
96,4%
Individual
Therapy
15,8%
50%*
70,4%
* Increased need for psychotherapy in the mere group intervention.
Preliminary results (n = 68) at six month follow-up
• The response rates are different in the three treatment
conditions:
CM:
PEC-G:
PEC-GI:
50%
39,3%
81,3%
• The rehospitalisation rate (intent to treat) is not different:
CM:
PEC-G:
PEC-GI:
16,7%
15,0%
18,5%
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.
Sustainability
After finishing the study intervention in August 2003 in Munich the psychoeducational-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
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
Treatment plan of the PEC
Session
Modul
Contents
1-3
Psychoeducation

4-6
Activation

7 - 10
Cognitive
therapy
11 -12
Relapse
prevention

13 -16
Booster
sessions
 Support to transfer these contents in daily living
Symptoms
 Aetiology
 Treatment options
Relationship between behaviour and mood
 Planning positive activities
 Balance between requests and positive activities (Self
rewarding
plans)
 Relationship between thoughts and mood (ABC-Schema)
 Identifying and modifying depressive thoughts
 Identifying depressive dysfunctional beliefs
 Modifying depressive dysfunctional beliefs
Pharmacological and psychosocial interventions
 Emergency plan
 Dealing with the illness in social contacts
 Exchange of participants‘ experiences