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NCT Number: NCT01655368

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik für Psychiatrie und Psychotherapie der RWTH, Aachen, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

psychotherapeutic STEM modules

Behavioral

psychoeducational and psychotherapeutical group intervention. 8 sessions of psychoeducation + 3 sessions + 1 booster session of STEM module for schizophrenia or depression)

Interventional control of normal psychoeducational treatment

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. self-stigma (ISMI)

    Time frame: after 6 weeks, 6 months, 12 months

  2. empowerment (BUES)

    Time frame: after 6 weeks, 6 months, 12 months

  3. health care utilization (CSSRI, EQ5-D, SF-36)

    Time frame: after 6 weeks, 6 months, 12 months

Sponsors and collaborators

Lead sponsor

Wolfgang Gaebel, Professor

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Acronym: STEM

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 1, 2012
Registry last updated
Jun 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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