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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Schizophrenia, Depression

Intervention / Treatment
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* Behavioral: psychotherapeutic STEM modules
* Behavioral: Interventional control of normal psychoeducational treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional: STEM modules<br>8 sessions of psychoeducation + 3 sessions + 1 booster session of STEM module (for schizophrenia or depression) | Behavioral: psychotherapeutic STEM modules<br>* psychoeducational and psychotherapeutical group intervention. 8 sessions of psychoeducation + 3 sessions + 1 booster session of STEM module for schizophrenia or depression)<br>|
| Other: Interventional Control<br>11 sessions + 1 booster session of psychoeducation for schizophrenia or depression) | Behavioral: Interventional control of normal psychoeducational treatment<br>* 11 sessions + 1 booster session of psychoeducation (for schizophrenia or depression)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months after intervention | 

Secondary Outcome Measures

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