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

June 14, 2016 updated by: Wolfgang Gaebel, Professor
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

486

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany, 52074
        • Klinik für Psychiatrie und Psychotherapie der RWTH
      • Berlin, Germany, 10589
        • Facharztpraxis Dr. Mönter
      • Berlin, Germany, 10589
        • Facharztpraxis Gereke
      • Berlin, Germany, 12203
        • Facharztpraxis Alicia Navarro Urena
      • Blieskastel, Germany, 66440
        • MediClin Bliestal Kliniken, Fachklinik für psychosomatische Medizin
      • Boppard-Bad Salzig, Germany, 56154
        • Mittelrhein-Klinik Bad Salzig der DRV
      • Cologne, Germany, 50937
        • Klinik für Psychiatrie und Psychotherapie, Universität zu Köln
      • Düsseldorf, Germany, 40211
        • Facharztpraxis, Dr. Frosch
      • Düsseldorf, Germany, 40227
        • Facharztpraxis Dr. Kuhlbusch
      • Düsseldorf, Germany, 40629
        • LVR-Klinikum Düsseldorf - Kliniken der Heinrich-Heine Universität
      • Göttingen, Germany, 37075
        • Klinik für Psychiatrie und Psychotherapie, Uniklinik Göttingen
      • Hamburg, Germany, 20246
        • Klinik für Psychiatrie und Psychotherapie, UKE
      • Hennigsdorf, Germany, 16761
        • Oberhavel Kliniken Hennigsdorf
      • Löhne, Germany, 32584
        • Berolina Klinik
      • Marburg, Germany, 35039
        • Klinik für Psychiatrie und Psychotherapie der Uniklinik Marburg
      • Munich, Germany, 80336
        • Klinik fur Psychiatrie und Psychotherapie, LMU
      • Teltow, Germany, 14513
        • Reha-Zentrum Seehof der DRV
      • Tübingen, Germany, 72072
        • Psychiatrisch-psychotherapeutisches Rehabilitationszentrum grund.stein
      • Tübingen, Germany, 72076
        • Klinik für Psychiatrie und Psychotherapie
      • Waren (Müritz), Germany, 17192
        • AHG Klinik Waren

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
subjective quality of life
Time Frame: 12 months after intervention

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.
12 months after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
self-stigma (ISMI)
Time Frame: after 6 weeks, 6 months, 12 months
after 6 weeks, 6 months, 12 months
empowerment (BUES)
Time Frame: after 6 weeks, 6 months, 12 months
after 6 weeks, 6 months, 12 months
health care utilization (CSSRI, EQ5-D, SF-36)
Time Frame: after 6 weeks, 6 months, 12 months
after 6 weeks, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wolfgang Gaebel, Professor

Collaborators

German Federal Ministry of Education and Research

Investigators

  • Principal Investigator: Wolfgang Gaebel, Prof. Dr., LVR-Klinikum Düsseldorf Kliniken der Heinrich-Heine-Universität Düsseldorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 14, 2012

First Submitted That Met QC Criteria

July 30, 2012

First Posted (Estimate)

August 1, 2012

Study Record Updates

Last Update Posted (Estimate)

June 15, 2016

Last Update Submitted That Met QC Criteria

June 14, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STEM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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