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

This study is currently recruiting participants.
Verified March 2014 by Heinrich-Heine University, Duesseldorf
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Wolfgang Gaebel, Professor, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT01655368
First received: June 14, 2012
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Schizophrenia
Depression
Behavioral: psychotherapeutic STEM modules
Behavioral: Interventional control of normal psychoeducational treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Group Intervention for Improving Stigma Coping and Empowerment of People With Mental Illness (STEM)

Resource links provided by NLM:


Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • subjective quality of life [ Time Frame: 12 months after intervention ] [ Designated as safety issue: No ]

    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) [ Time Frame: after 6 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
  • empowerment (BUES) [ Time Frame: after 6 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
  • health care utilization (CSSRI, EQ5-D, SF-36) [ Time Frame: after 6 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 512
Study Start Date: May 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interventional: STEM modules
8 sessions of psychoeducation + 3 sessions + 1 booster session of STEM module (for schizophrenia or depression)
Behavioral: psychotherapeutic STEM modules
psychoeducational and psychotherapeutical group intervention. 8 sessions of psychoeducation + 3 sessions + 1 booster session of STEM module for schizophrenia or depression)
Interventional Control
11 sessions + 1 booster session of psychoeducation for schizophrenia or depression)
Behavioral: Interventional control of normal psychoeducational treatment
11 sessions + 1 booster session of psychoeducation (for schizophrenia or depression)

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655368

Contacts
Contact: Wolfgang Gaebel, Prof. Dr. 0049 211 922 20 00 wolfgang.gaebel@uni-duesseldorf.de
Contact: Andrea Siegert 0049 211 922 277 4 andrea.siegert@lvr.de

Locations
Germany
Klinik für Psychiatrie und Psychotherapie der RWTH Recruiting
Aachen, Germany, 52074
Contact: Frank Schneider, Prof. Dr.         
Reha-Zentrum Bad Frankenhausen der DRV Withdrawn
Bad Frankenhausen, Germany, 06567
Marbachtalklinik der DRV, Bad Kissingen Withdrawn
Bad Kissingen, Germany, 97688
Reha-Zentrum Bad Kissingen, Kliniken Rhön und Saale der DRV Withdrawn
Bad Kissingen, Germany, 97688
Facharztpraxis Gereke Completed
Berlin, Germany, 10589
Facharztpraxis Dr. Mönter Completed
Berlin, Germany, 10589
Facharztpraxis Alicia Navarro Urena Completed
Berlin, Germany, 12203
MediClin Bliestal Kliniken, Fachklinik für psychosomatische Medizin Completed
Blieskastel, Germany, 66440
Mittelrhein-Klinik Bad Salzig der DRV Completed
Boppard-Bad Salzig, Germany, 56154
Klinik für Psychiatrie und Psychotherapie, Universität zu Köln Completed
Cologne, Germany, 50937
Facharztpraxis, Dr. Frosch Completed
Düsseldorf, Germany, 40211
LVR-Klinikum Düsseldorf - Kliniken der Heinrich-Heine Universität Completed
Düsseldorf, Germany, 40629
Facharztpraxis Dr. Kuhlbusch Completed
Düsseldorf, Germany, 40227
Klinik für Psychiatrie und Psychotherapie, Uniklinik Göttingen Completed
Göttingen, Germany, 37075
Klinik für Psychiatrie und Psychotherapie, UKE Completed
Hamburg, Germany, 20246
Oberhavel Kliniken Hennigsdorf Completed
Hennigsdorf, Germany, 16761
Berolina Klinik Completed
Löhne, Germany, 32584
Klinik für Psychiatrie und Psychotherapie der Uniklinik Marburg Completed
Marburg, Germany, 35039
Klinik für Psychiatrie und Psychotherapie, LMU Completed
Munich, Germany, 80336
Reha-Zentrum Seehof der DRV Completed
Teltow, Germany, 14513
Psychiatrisch-psychotherapeutisches Rehabilitationszentrum grund.stein Completed
Tübingen, Germany, 72072
Klinik für Psychiatrie und Psychotherapie Completed
Tübingen, Germany, 72076
AHG Klinik Waren Completed
Waren (Müritz), Germany, 17192
Sponsors and Collaborators
Wolfgang Gaebel, Professor
German Federal Ministry of Education and Research
  More Information

Additional Information:
Publications:
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
Sartorius N, Schulze H. Reducing the stigma of mental illness. Cambridge University Press, Cambridge 2005

Responsible Party: Wolfgang Gaebel, Professor, Professor Dr., Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT01655368     History of Changes
Other Study ID Numbers: STEM
Study First Received: June 14, 2012
Last Updated: March 17, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Mental Disorders
Depression
Depressive Disorder
Schizophrenia
Behavioral Symptoms
Mood Disorders
Schizophrenia and Disorders with Psychotic Features
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014