Group Intervention for Improving Stigma Coping and Empowerment of People With Mental Illness (STEM)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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) |
- 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.
- 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 |
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| Contact: Wolfgang Gaebel, Prof. Dr. | 0049 211 922 20 00 | wolfgang.gaebel@uni-duesseldorf.de |
| Contact: Stefanie Sauter | 0049 211 922 277 4 | stefanie.sauter@lvr.de |
| 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 | Recruiting |
| Berlin, Germany, 10589 | |
| Contact: Stephanie Gereke | |
| Facharztpraxis Dr. Mönter | Completed |
| Berlin, Germany, 10589 | |
| Facharztpraxis Alicia Navarro Urena | Recruiting |
| Berlin, Germany, 12203 | |
| Contact: Alicia Navarro Urena | |
| MediClin Bliestal Kliniken, Fachklinik für psychosomatische Medizin | Not yet recruiting |
| Blieskastel, Germany, 66440 | |
| Contact: Volker Köllner, Prof. Dr. | |
| Mittelrhein-Klinik Bad Salzig der DRV | Not yet recruiting |
| Boppard-Bad Salzig, Germany, 56154 | |
| Contact: Matthias Rudolph, Dr. | |
| Klinik für Psychiatrie und Psychotherapie, Universität zu Köln | Recruiting |
| Cologne, Germany, 50937 | |
| Contact: Andreas Bechdolf, Dr. | |
| Facharztpraxis, Dr. Frosch | Recruiting |
| Düsseldorf, Germany, 40211 | |
| Contact: Günther Frosch, Dr. | |
| LVR-Klinikum Düsseldorf - Kliniken der Heinrich-Heine Universität | Recruiting |
| Düsseldorf, Germany, 40629 | |
| Contact: Wolfgang Gaebel, Prof. Dr. | |
| Facharztpraxis Dr. Kuhlbusch | Recruiting |
| Düsseldorf, Germany, 40227 | |
| Contact: Franz-Josef Kuhlbusch | |
| Klinik für Psychiatrie und Psychotherapie, Uniklinik Göttingen | Recruiting |
| Göttingen, Germany, 37075 | |
| Contact: Claus Wolff-Menzler, Dr. | |
| Klinik für Psychiatrie und Psychotherapie, UKE | Completed |
| Hamburg, Germany, 20246 | |
| Oberhavel Kliniken Hennigsdorf | Recruiting |
| Hennigsdorf, Germany, 16761 | |
| Contact: Timo Krüger | |
| Berolina Klinik | Not yet recruiting |
| Löhne, Germany, 32584 | |
| Contact: Gerhard Schmid-Ott, Prof. Dr. | |
| Klinik für Psychiatrie und Psychotherapie der Uniklinik Marburg | Recruiting |
| Marburg, Germany, 35039 | |
| Contact: Tilo Kircher, Prof. Dr. | |
| Klinik für Psychiatrie und Psychotherapie, LMU | Recruiting |
| Munich, Germany, 80336 | |
| Contact: Anette Schaub, Dr. | |
| Reha-Zentrum Seehof der DRV | Completed |
| Teltow, Germany, 14513 | |
| Psychiatrisch-psychotherapeutisches Rehabilitationszentrum grund.stein | Completed |
| Tübingen, Germany, 72072 | |
| Klinik für Psychiatrie und Psychotherapie | Recruiting |
| Tübingen, Germany, 72076 | |
| Contact: Stefan Klingberg, Prof. Dr. | |
| AHG Klinik Waren | Completed |
| Waren (Müritz), Germany, 17192 | |
More Information
Additional Information:
Publications:
| 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: | May 8, 2013 |
| 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 June 17, 2013