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

Depression Clinical Trial

— STEM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01655368
• Other study ID #: STEM
• Status: Completed
• Phase: N/A
• First received: June 14, 2012
• Last updated: June 14, 2016
• Start date: May 2012
• Est. completion date: June 2015

Study information

• Verified date: June 2016
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 486
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Mental Disorders
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
Germany	Klinik für Psychiatrie und Psychotherapie der RWTH	Aachen
Germany	Facharztpraxis Alicia Navarro Urena	Berlin
Germany	Facharztpraxis Dr. Mönter	Berlin
Germany	Facharztpraxis Gereke	Berlin
Germany	MediClin Bliestal Kliniken, Fachklinik für psychosomatische Medizin	Blieskastel
Germany	Mittelrhein-Klinik Bad Salzig der DRV	Boppard-Bad Salzig
Germany	Klinik für Psychiatrie und Psychotherapie, Universität zu Köln	Cologne
Germany	Facharztpraxis Dr. Kuhlbusch	Düsseldorf
Germany	Facharztpraxis, Dr. Frosch	Düsseldorf
Germany	LVR-Klinikum Düsseldorf - Kliniken der Heinrich-Heine Universität	Düsseldorf
Germany	Klinik für Psychiatrie und Psychotherapie, Uniklinik Göttingen	Göttingen
Germany	Klinik für Psychiatrie und Psychotherapie, UKE	Hamburg
Germany	Oberhavel Kliniken Hennigsdorf	Hennigsdorf
Germany	Berolina Klinik	Löhne
Germany	Klinik für Psychiatrie und Psychotherapie der Uniklinik Marburg	Marburg
Germany	Klinik für Psychiatrie und Psychotherapie, LMU	Munich
Germany	Reha-Zentrum Seehof der DRV	Teltow
Germany	Klinik für Psychiatrie und Psychotherapie	Tübingen
Germany	Psychiatrisch-psychotherapeutisches Rehabilitationszentrum grund.stein	Tübingen
Germany	AHG Klinik Waren	Waren (Müritz)

Sponsors (2)

Lead Sponsor	Collaborator
Wolfgang Gaebel, Professor	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

References & Publications (19)

Barrowclough C, Haddock G, Lobban F, Jones S, Siddle R, Roberts C, Gregg L. Group cognitive-behavioural therapy for schizophrenia. Randomised controlled trial. Br J Psychiatry. 2006 Dec;189:527-32. — View Citation

Corrigan P, Lundin R. Don´t call me nuts: Coping with the stigma of mental illness. Recovery Press, Chicago 2001

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

Gaebel W, Baumann AE. Interventions to reduce the stigma associated with severe mental illness: experiences from the open the doors program in Germany. Can J Psychiatry. 2003 Nov;48(10):657-62. — View Citation

Gaebel W, Zäske H, Baumann A (2004) Stigma erschwert Behandlung und Integration. Dtsch Ärztebl 101: A3253-3255

Gaebel W, Zäske H, Baumann AE, Klosterkötter J, Maier W, Decker P, Möller HJ. Evaluation of the German WPA "program against stigma and discrimination because of schizophrenia--Open the Doors": results from representative telephone surveys before and after three years of antistigma interventions. Schizophr Res. 2008 Jan;98(1-3):184-93. Epub 2007 Oct 24. — View Citation

Lawrence R, Bradshaw T, Mairs H. Group cognitive behavioural therapy for schizophrenia: a systematic review of the literature. J Psychiatr Ment Health Nurs. 2006 Dec;13(6):673-81. Review. — View Citation

Link BG, Phelan JC. Labeling and stigma. In: The Handbook of the Sociology of Mental Health, Hrsg. CS Aneshensel, JC Phelan. Plenum, New York 1999

Link BG, Struening EL, Neese-Todd S, Asmussen S, Phelan JC. Stigma as a barrier to recovery: The consequences of stigma for the self-esteem of people with mental illnesses. Psychiatr Serv. 2001 Dec;52(12):1621-6. — View Citation

Lysaker PH, Roe D, Yanos PT. Toward understanding the insight paradox: internalized stigma moderates the association between insight and social functioning, hope, and self-esteem among people with schizophrenia spectrum disorders. Schizophr Bull. 2007 Jan;33(1):192-9. Epub 2006 Aug 7. — View Citation

McDermut W, Miller IW, Brown RA (2006) The Efficacy of Group Psychotherapy for Depression: A Meta-analysis and Review of the Empirical Research. Clinical Psychol: Science and Practice 8: 98-116

Perlick DA, Rosenheck RA, Clarkin JF, Sirey JA, Salahi J, Struening EL, Link BG. Stigma as a barrier to recovery: Adverse effects of perceived stigma on social adaptation of persons diagnosed with bipolar affective disorder. Psychiatr Serv. 2001 Dec;52(12):1627-32. — View Citation

Ritsher JB, Otilingam PG, Grajales M. Internalized stigma of mental illness: psychometric properties of a new measure. Psychiatry Res. 2003 Nov 1;121(1):31-49. — View Citation

Ritsher JB, Phelan JC. Internalized stigma predicts erosion of morale among psychiatric outpatients. Psychiatry Res. 2004 Dec 30;129(3):257-65. — View Citation

Rüesch P. Soziale Netzwerke und Lebensqualität. In: Gaebel W, Möller HJ, Rössler W (Hrsg). Stigma - Diskriminierung - Bewältigung. Kohlhammer, Stuttgart 2005

Rüsch N, Corrigan PW, Wassel A, Michaels P, Larson JE, Olschewski M, Wilkniss S, Batia K. Self-stigma, group identification, perceived legitimacy of discrimination and mental health service use. Br J Psychiatry. 2009 Dec;195(6):551-2. doi: 10.1192/bjp.bp.109.067157. — View Citation

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

Sirey JA, Bruce ML, Alexopoulos GS, Perlick DA, Friedman SJ, Meyers BS. Stigma as a barrier to recovery: Perceived stigma and patient-rated severity of illness as predictors of antidepressant drug adherence. Psychiatr Serv. 2001 Dec;52(12):1615-20. — View Citation

Watson AC, Corrigan P, Larson JE, Sells M. Self-stigma in people with mental illness. Schizophr Bull. 2007 Nov;33(6):1312-8. Epub 2007 Jan 25. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	self-stigma (ISMI)		after 6 weeks, 6 months, 12 months	No
Secondary	empowerment (BUES)		after 6 weeks, 6 months, 12 months	No
Secondary	health care utilization (CSSRI, EQ5-D, SF-36)		after 6 weeks, 6 months, 12 months	No

External Links

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