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Group Intervention for Improving Stigma Coping and Empowerment of People With Mental Illness (STEM) (STEM)

Primary Purpose

Schizophrenia, Depression

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
psychotherapeutic STEM modules
Interventional control of normal psychoeducational treatment
Sponsored by
Wolfgang Gaebel, Professor
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 - 65 years
  • ICD-10 diagnosis of F2, F31.3-31.5, F32-34, F34.2, F43.2
  • patients who would participate in a psychoeducational group therapy in their regular treatment
  • written informed consent of the patient willing to participate
  • capacity of giving consent (as diagnosed by the investigator)

Exclusion Criteria:

  • insufficient knowledge of german language (reading, understanding and speaking not sufficient, as judged by the investigator)
  • acute psychotic or dissociative condition

Sites / Locations

  • Klinik für Psychiatrie und Psychotherapie der RWTH
  • Facharztpraxis Dr. Mönter
  • Facharztpraxis Gereke
  • Facharztpraxis Alicia Navarro Urena
  • MediClin Bliestal Kliniken, Fachklinik für psychosomatische Medizin
  • Mittelrhein-Klinik Bad Salzig der DRV
  • Klinik für Psychiatrie und Psychotherapie, Universität zu Köln
  • Facharztpraxis, Dr. Frosch
  • Facharztpraxis Dr. Kuhlbusch
  • LVR-Klinikum Düsseldorf - Kliniken der Heinrich-Heine Universität
  • Klinik für Psychiatrie und Psychotherapie, Uniklinik Göttingen
  • Klinik für Psychiatrie und Psychotherapie, UKE
  • Oberhavel Kliniken Hennigsdorf
  • Berolina Klinik
  • Klinik für Psychiatrie und Psychotherapie der Uniklinik Marburg
  • Klinik für Psychiatrie und Psychotherapie, LMU
  • Reha-Zentrum Seehof der DRV
  • Psychiatrisch-psychotherapeutisches Rehabilitationszentrum grund.stein
  • Klinik für Psychiatrie und Psychotherapie
  • AHG Klinik Waren

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Interventional: STEM modules

Interventional Control

Arm Description

8 sessions of psychoeducation + 3 sessions + 1 booster session of STEM module (for schizophrenia or depression)

11 sessions + 1 booster session of psychoeducation for schizophrenia or depression)

Outcomes

Primary Outcome Measures

subjective quality of life
subjective quality of life 12 months after intervention determined by WHOQOL-BREF total score. To impart coping-strategies in handling stigmatization and to develop empowerment by embedding a psychotherapeutic module in psychoeducational groups.

Secondary Outcome Measures

self-stigma (ISMI)
empowerment (BUES)
health care utilization (CSSRI, EQ5-D, SF-36)

Full Information

First Posted
June 14, 2012
Last Updated
June 14, 2016
Sponsor
Wolfgang Gaebel, Professor
Collaborators
German Federal Ministry of Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT01655368
Brief Title
Group Intervention for Improving Stigma Coping and Empowerment of People With Mental Illness (STEM)
Acronym
STEM
Official Title
Group Intervention for Improving Stigma Coping and Empowerment of People With Mental Illness (STEM)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wolfgang Gaebel, Professor
Collaborators
German Federal Ministry of Education and Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This multi-center, 2-arm interventional study within different mental health care settings (psychiatry: in-patient, day-unit and out-patient, as well as psychiatric rehabilitation) evaluates a psychotherapeutic group intervention to improve stigma coping and empowerment using a psychotherapeutic module embedded in a psychoeducational group therapy.
Detailed Description
People with mental illness suffer both from the burden of disease itself and from the social stigma related to mental illness, hence impeding their treatment (Sartorius et al. 2005, Link et al. 1999). Negative attitudes towards and discriminating behavior against people with mental illness negatively affect health care utilization, the course of disease, compliance, self-esteem, and social functioning (Sirey et al. 2001, Link et al. 2001, Perlick et al. 2001). Internalizing negative social stereotypes (self-stigmatization; Ritsher et al. 2003, Watson et al. 2007) impairs the quality of life and leads to social withdrawal (Rüesch 2005). Furthermore, self stigma is associated with lower empowerment (Ritsher et al. 2004), a poorer social network (Lysaker et al. 2007), lower compliance (Fung et al. 2008) and a higher extent of symptoms (Corrigan et al. 2006). The stigma of mental illness leads to an impaired pursuance of individual life goals, as job-related ambitions or living in a relationship (Rüesch 2005). Current approaches targeting the stigma of mental illness primarily focus on education about mental illness in different target groups (e.g. Gaebel et al. 2003, 2004) and can be successful, if appropriately implemented (Gaebel et al. 2008). Yet there is a lack of RCT-tested psychotherapeutic approaches which directly address patients with mental illness improving their skills of coping with stigma and discrimination. Therefore it is intended to develop, manualise, and to evaluate such a psychotherapeutic group intervention within a randomized clinical control group design. In this context, group-based cognitive-behavioral psychotherapy has been proved as efficient therapeutic approach for patients with depression (cf. McDermut et al. 2006) and with schizophrenia (cf. Lawrence et al. 2006, Barrowclough et al. 2006) in different settings. Patients can serve each other as role models and will modify negative self-related cognitions, thus developing new cognitions supporting self-esteem (Corrigan et al. 2001). The following interventional effects should improve the patients' quality of life and also result in a reduction of frequency and length of inpatient stays and sickness-related absenteeism: improved skills to cope with negative stigmatizing experiences, a reduced burden through of self-stigmatizing cognitions, a better utilization of resources for disease managing in coherence with reduced self-stigmatization, and an improved coping with stigma-related conflicts at work.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
486 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional: STEM modules
Arm Type
Experimental
Arm Description
8 sessions of psychoeducation + 3 sessions + 1 booster session of STEM module (for schizophrenia or depression)
Arm Title
Interventional Control
Arm Type
Other
Arm Description
11 sessions + 1 booster session of psychoeducation for schizophrenia or depression)
Intervention Type
Behavioral
Intervention Name(s)
psychotherapeutic STEM modules
Intervention Description
psychoeducational and psychotherapeutical group intervention. 8 sessions of psychoeducation + 3 sessions + 1 booster session of STEM module for schizophrenia or depression)
Intervention Type
Behavioral
Intervention Name(s)
Interventional control of normal psychoeducational treatment
Intervention Description
11 sessions + 1 booster session of psychoeducation (for schizophrenia or depression)
Primary Outcome Measure Information:
Title
subjective quality of life
Description
subjective quality of life 12 months after intervention determined by WHOQOL-BREF total score. To impart coping-strategies in handling stigmatization and to develop empowerment by embedding a psychotherapeutic module in psychoeducational groups.
Time Frame
12 months after intervention
Secondary Outcome Measure Information:
Title
self-stigma (ISMI)
Time Frame
after 6 weeks, 6 months, 12 months
Title
empowerment (BUES)
Time Frame
after 6 weeks, 6 months, 12 months
Title
health care utilization (CSSRI, EQ5-D, SF-36)
Time Frame
after 6 weeks, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 - 65 years ICD-10 diagnosis of F2, F31.3-31.5, F32-34, F34.2, F43.2 patients who would participate in a psychoeducational group therapy in their regular treatment written informed consent of the patient willing to participate capacity of giving consent (as diagnosed by the investigator) Exclusion Criteria: insufficient knowledge of german language (reading, understanding and speaking not sufficient, as judged by the investigator) acute psychotic or dissociative condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Gaebel, Prof. Dr.
Organizational Affiliation
LVR-Klinikum Düsseldorf Kliniken der Heinrich-Heine-Universität Düsseldorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Psychiatrie und Psychotherapie der RWTH
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Facharztpraxis Dr. Mönter
City
Berlin
ZIP/Postal Code
10589
Country
Germany
Facility Name
Facharztpraxis Gereke
City
Berlin
ZIP/Postal Code
10589
Country
Germany
Facility Name
Facharztpraxis Alicia Navarro Urena
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
MediClin Bliestal Kliniken, Fachklinik für psychosomatische Medizin
City
Blieskastel
ZIP/Postal Code
66440
Country
Germany
Facility Name
Mittelrhein-Klinik Bad Salzig der DRV
City
Boppard-Bad Salzig
ZIP/Postal Code
56154
Country
Germany
Facility Name
Klinik für Psychiatrie und Psychotherapie, Universität zu Köln
City
Cologne
ZIP/Postal Code
50937
Country
Germany
Facility Name
Facharztpraxis, Dr. Frosch
City
Düsseldorf
ZIP/Postal Code
40211
Country
Germany
Facility Name
Facharztpraxis Dr. Kuhlbusch
City
Düsseldorf
ZIP/Postal Code
40227
Country
Germany
Facility Name
LVR-Klinikum Düsseldorf - Kliniken der Heinrich-Heine Universität
City
Düsseldorf
ZIP/Postal Code
40629
Country
Germany
Facility Name
Klinik für Psychiatrie und Psychotherapie, Uniklinik Göttingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Klinik für Psychiatrie und Psychotherapie, UKE
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Oberhavel Kliniken Hennigsdorf
City
Hennigsdorf
ZIP/Postal Code
16761
Country
Germany
Facility Name
Berolina Klinik
City
Löhne
ZIP/Postal Code
32584
Country
Germany
Facility Name
Klinik für Psychiatrie und Psychotherapie der Uniklinik Marburg
City
Marburg
ZIP/Postal Code
35039
Country
Germany
Facility Name
Klinik für Psychiatrie und Psychotherapie, LMU
City
Munich
ZIP/Postal Code
80336
Country
Germany
Facility Name
Reha-Zentrum Seehof der DRV
City
Teltow
ZIP/Postal Code
14513
Country
Germany
Facility Name
Psychiatrisch-psychotherapeutisches Rehabilitationszentrum grund.stein
City
Tübingen
ZIP/Postal Code
72072
Country
Germany
Facility Name
Klinik für Psychiatrie und Psychotherapie
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
AHG Klinik Waren
City
Waren (Müritz)
ZIP/Postal Code
17192
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
17139037
Citation
Barrowclough C, Haddock G, Lobban F, Jones S, Siddle R, Roberts C, Gregg L. Group cognitive-behavioural therapy for schizophrenia. Randomised controlled trial. Br J Psychiatry. 2006 Dec;189:527-32. doi: 10.1192/bjp.bp.106.021386.
Results Reference
background
Citation
Corrigan P, Lundin R. Don´t call me nuts: Coping with the stigma of mental illness. Recovery Press, Chicago 2001
Results Reference
background
Citation
Corrigan PW, Watson AC, Barr L (2006) The Self-Stigma of Mental Illness: Implications for Self-Esteem and Self-Efficacy. J Soc Clin Psychol 25: 875-884
Results Reference
background
PubMed Identifier
14674047
Citation
Gaebel W, Baumann AE. Interventions to reduce the stigma associated with severe mental illness: experiences from the open the doors program in Germany. Can J Psychiatry. 2003 Nov;48(10):657-62. doi: 10.1177/070674370304801003.
Results Reference
background
Citation
Gaebel W, Zäske H, Baumann A (2004) Stigma erschwert Behandlung und Integration. Dtsch Ärztebl 101: A3253-3255
Results Reference
background
PubMed Identifier
17961985
Citation
Gaebel W, Zaske H, Baumann AE, Klosterkotter J, Maier W, Decker P, Moller HJ. Evaluation of the German WPA "program against stigma and discrimination because of schizophrenia--Open the Doors": results from representative telephone surveys before and after three years of antistigma interventions. Schizophr Res. 2008 Jan;98(1-3):184-93. doi: 10.1016/j.schres.2007.09.013. Epub 2007 Oct 24.
Results Reference
background
PubMed Identifier
17087669
Citation
Lawrence R, Bradshaw T, Mairs H. Group cognitive behavioural therapy for schizophrenia: a systematic review of the literature. J Psychiatr Ment Health Nurs. 2006 Dec;13(6):673-81. doi: 10.1111/j.1365-2850.2006.01014.x.
Results Reference
background
Citation
Link BG, Phelan JC. Labeling and stigma. In: The Handbook of the Sociology of Mental Health, Hrsg. CS Aneshensel, JC Phelan. Plenum, New York 1999
Results Reference
background
PubMed Identifier
11726753
Citation
Link BG, Struening EL, Neese-Todd S, Asmussen S, Phelan JC. Stigma as a barrier to recovery: The consequences of stigma for the self-esteem of people with mental illnesses. Psychiatr Serv. 2001 Dec;52(12):1621-6. doi: 10.1176/appi.ps.52.12.1621.
Results Reference
background
PubMed Identifier
16894025
Citation
Lysaker PH, Roe D, Yanos PT. Toward understanding the insight paradox: internalized stigma moderates the association between insight and social functioning, hope, and self-esteem among people with schizophrenia spectrum disorders. Schizophr Bull. 2007 Jan;33(1):192-9. doi: 10.1093/schbul/sbl016. Epub 2006 Aug 7.
Results Reference
background
Citation
McDermut W, Miller IW, Brown RA (2006) The Efficacy of Group Psychotherapy for Depression: A Meta-analysis and Review of the Empirical Research. Clinical Psychol: Science and Practice 8: 98-116
Results Reference
background
PubMed Identifier
11726754
Citation
Perlick DA, Rosenheck RA, Clarkin JF, Sirey JA, Salahi J, Struening EL, Link BG. Stigma as a barrier to recovery: Adverse effects of perceived stigma on social adaptation of persons diagnosed with bipolar affective disorder. Psychiatr Serv. 2001 Dec;52(12):1627-32. doi: 10.1176/appi.ps.52.12.1627.
Results Reference
background
PubMed Identifier
14572622
Citation
Ritsher JB, Otilingam PG, Grajales M. Internalized stigma of mental illness: psychometric properties of a new measure. Psychiatry Res. 2003 Nov 1;121(1):31-49. doi: 10.1016/j.psychres.2003.08.008.
Results Reference
background
PubMed Identifier
15661319
Citation
Ritsher JB, Phelan JC. Internalized stigma predicts erosion of morale among psychiatric outpatients. Psychiatry Res. 2004 Dec 30;129(3):257-65. doi: 10.1016/j.psychres.2004.08.003.
Results Reference
background
PubMed Identifier
19949209
Citation
Rusch N, Corrigan PW, Wassel A, Michaels P, Larson JE, Olschewski M, Wilkniss S, Batia K. Self-stigma, group identification, perceived legitimacy of discrimination and mental health service use. Br J Psychiatry. 2009 Dec;195(6):551-2. doi: 10.1192/bjp.bp.109.067157.
Results Reference
background
Citation
Rüesch P. Soziale Netzwerke und Lebensqualität. In: Gaebel W, Möller HJ, Rössler W (Hrsg). Stigma - Diskriminierung - Bewältigung. Kohlhammer, Stuttgart 2005
Results Reference
background
Citation
Sartorius N, Schulze H. Reducing the stigma of mental illness. Cambridge University Press, Cambridge 2005
Results Reference
background
PubMed Identifier
11726752
Citation
Sirey JA, Bruce ML, Alexopoulos GS, Perlick DA, Friedman SJ, Meyers BS. Stigma as a barrier to recovery: Perceived stigma and patient-rated severity of illness as predictors of antidepressant drug adherence. Psychiatr Serv. 2001 Dec;52(12):1615-20. doi: 10.1176/appi.ps.52.12.1615.
Results Reference
background
PubMed Identifier
17255118
Citation
Watson AC, Corrigan P, Larson JE, Sells M. Self-stigma in people with mental illness. Schizophr Bull. 2007 Nov;33(6):1312-8. doi: 10.1093/schbul/sbl076. Epub 2007 Jan 25.
Results Reference
background
PubMed Identifier
31520149
Citation
Gaebel W, Zaske H, Hesse K, Klingberg S, Ohmann C, Grebe J, Kolbe H, Icks A, Schneider F, Backes V, Wolff-Menzler C, Guse B, Gallinat J, Bock T, Jockers-Scherubl MC, Kruger T, Jessen F, Bechdolf A, Kircher T, Konrad C, Falkai P, Schaub A, Rudolph M, Kollner V, Schmid-Ott G, Linden M, Lieberei B, Stuhlinger M, Sommerfeld S, Schumacher A, Krenge S, Gereke S, Monter N, Navarro-Urena A, Frosch G, Kuhlbusch FJ, Cleveland H, Riesbeck M. Promoting stigma coping and empowerment in patients with schizophrenia and depression: results of a cluster-RCT. Eur Arch Psychiatry Clin Neurosci. 2020 Aug;270(5):501-511. doi: 10.1007/s00406-019-01064-3. Epub 2019 Sep 13.
Results Reference
derived
Links:
URL
http://www.rk-duesseldorf.lvr.de
Description
homepage of the responsible party

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Group Intervention for Improving Stigma Coping and Empowerment of People With Mental Illness (STEM)

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