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

NCT ID: NCT01655368

Last Updated: 2016-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

486 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-06-30

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.

Conditions

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Schizophrenia Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interventional: STEM modules

8 sessions of psychoeducation + 3 sessions + 1 booster session of STEM module (for schizophrenia or depression)

Group Type EXPERIMENTAL

psychotherapeutic STEM modules

Intervention Type BEHAVIORAL

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)

Group Type OTHER

Interventional control of normal psychoeducational treatment

Intervention Type BEHAVIORAL

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

Interventions

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psychotherapeutic STEM modules

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

Intervention Type BEHAVIORAL

Interventional control of normal psychoeducational treatment

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

Wolfgang Gaebel, Professor

OTHER

Sponsor Role lead

Responsible Party

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Wolfgang Gaebel, Professor

Professor Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wolfgang Gaebel, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

LVR-Klinikum Düsseldorf Kliniken der Heinrich-Heine-Universität Düsseldorf

Locations

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Klinik für Psychiatrie und Psychotherapie der RWTH

Aachen, , Germany

Site Status

Facharztpraxis Dr. Mönter

Berlin, , Germany

Site Status

Facharztpraxis Gereke

Berlin, , Germany

Site Status

Facharztpraxis Alicia Navarro Urena

Berlin, , Germany

Site Status

MediClin Bliestal Kliniken, Fachklinik für psychosomatische Medizin

Blieskastel, , Germany

Site Status

Mittelrhein-Klinik Bad Salzig der DRV

Boppard-Bad Salzig, , Germany

Site Status

Klinik für Psychiatrie und Psychotherapie, Universität zu Köln

Cologne, , Germany

Site Status

Facharztpraxis, Dr. Frosch

Düsseldorf, , Germany

Site Status

Facharztpraxis Dr. Kuhlbusch

Düsseldorf, , Germany

Site Status

LVR-Klinikum Düsseldorf - Kliniken der Heinrich-Heine Universität

Düsseldorf, , Germany

Site Status

Klinik für Psychiatrie und Psychotherapie, Uniklinik Göttingen

Göttingen, , Germany

Site Status

Klinik für Psychiatrie und Psychotherapie, UKE

Hamburg, , Germany

Site Status

Oberhavel Kliniken Hennigsdorf

Hennigsdorf, , Germany

Site Status

Berolina Klinik

Löhne, , Germany

Site Status

Klinik für Psychiatrie und Psychotherapie der Uniklinik Marburg

Marburg, , Germany

Site Status

Klinik für Psychiatrie und Psychotherapie, LMU

Munich, , Germany

Site Status

Reha-Zentrum Seehof der DRV

Teltow, , Germany

Site Status

Psychiatrisch-psychotherapeutisches Rehabilitationszentrum grund.stein

Tübingen, , Germany

Site Status

Klinik für Psychiatrie und Psychotherapie

Tübingen, , Germany

Site Status

AHG Klinik Waren

Waren (Müritz), , Germany

Site Status

Countries

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Germany

References

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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. doi: 10.1192/bjp.bp.106.021386.

Reference Type BACKGROUND
PMID: 17139037 (View on PubMed)

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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. doi: 10.1177/070674370304801003.

Reference Type BACKGROUND
PMID: 14674047 (View on PubMed)

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

Reference Type BACKGROUND

Gaebel W, Zaske H, Baumann AE, Klosterkotter J, Maier W, Decker P, Moller 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. doi: 10.1016/j.schres.2007.09.013. Epub 2007 Oct 24.

Reference Type BACKGROUND
PMID: 17961985 (View on PubMed)

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. doi: 10.1111/j.1365-2850.2006.01014.x.

Reference Type BACKGROUND
PMID: 17087669 (View on PubMed)

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

Reference Type BACKGROUND

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. doi: 10.1176/appi.ps.52.12.1621.

Reference Type BACKGROUND
PMID: 11726753 (View on PubMed)

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. doi: 10.1093/schbul/sbl016. Epub 2006 Aug 7.

Reference Type BACKGROUND
PMID: 16894025 (View on PubMed)

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

Reference Type BACKGROUND

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. doi: 10.1176/appi.ps.52.12.1627.

Reference Type BACKGROUND
PMID: 11726754 (View on PubMed)

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. doi: 10.1016/j.psychres.2003.08.008.

Reference Type BACKGROUND
PMID: 14572622 (View on PubMed)

Ritsher JB, Phelan JC. Internalized stigma predicts erosion of morale among psychiatric outpatients. Psychiatry Res. 2004 Dec 30;129(3):257-65. doi: 10.1016/j.psychres.2004.08.003.

Reference Type BACKGROUND
PMID: 15661319 (View on PubMed)

Rusch 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.

Reference Type BACKGROUND
PMID: 19949209 (View on PubMed)

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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. doi: 10.1176/appi.ps.52.12.1615.

Reference Type BACKGROUND
PMID: 11726752 (View on PubMed)

Watson AC, Corrigan P, Larson JE, Sells M. Self-stigma in people with mental illness. Schizophr Bull. 2007 Nov;33(6):1312-8. doi: 10.1093/schbul/sbl076. Epub 2007 Jan 25.

Reference Type BACKGROUND
PMID: 17255118 (View on PubMed)

Gaebel W, Zaske H, Hesse K, Klingberg S, Ohmann C, Grebe J, Kolbe H, Icks A, Schneider F, Backes V, Wolff-Menzler C, Guse B, Gallinat J, Bock T, Jockers-Scherubl MC, Kruger T, Jessen F, Bechdolf A, Kircher T, Konrad C, Falkai P, Schaub A, Rudolph M, Kollner V, Schmid-Ott G, Linden M, Lieberei B, Stuhlinger M, Sommerfeld S, Schumacher A, Krenge S, Gereke S, Monter N, Navarro-Urena A, Frosch G, Kuhlbusch FJ, Cleveland H, Riesbeck M. Promoting stigma coping and empowerment in patients with schizophrenia and depression: results of a cluster-RCT. Eur Arch Psychiatry Clin Neurosci. 2020 Aug;270(5):501-511. doi: 10.1007/s00406-019-01064-3. Epub 2019 Sep 13.

Reference Type DERIVED
PMID: 31520149 (View on PubMed)

Related Links

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http://www.rk-duesseldorf.lvr.de

homepage of the responsible party

Other Identifiers

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STEM

Identifier Type: -

Identifier Source: org_study_id

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