Clinical trial NCT01655368: Group Intervention for Improving Stigma Coping and Empowerment of People With Mental Illness (STEM)
Official title: Group Intervention for Improving Stigma Coping and Empowerment of People With Mental Illness (STEM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Depression
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2012-08-01
Enrollment: 486
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 criteria: 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

Primary outcomes:
measure: subjective quality of life
timeFrame: 12 months after intervention
Secondary outcomes:
measure: self-stigma (ISMI)
timeFrame: after 6 weeks, 6 months, 12 months
measure: empowerment (BUES)
timeFrame: after 6 weeks, 6 months, 12 months
measure: health care utilization (CSSRI, EQ5-D, SF-36)
timeFrame: after 6 weeks, 6 months, 12 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Klinik für Psychiatrie und Psychotherapie der RWTH
city: Berlin
country: Germany
facility: Facharztpraxis Dr. Mönter
city: Berlin
country: Germany
facility: Facharztpraxis Gereke
city: Berlin
country: Germany
facility: Facharztpraxis Alicia Navarro Urena
city: Blieskastel
country: Germany
facility: MediClin Bliestal Kliniken, Fachklinik für psychosomatische Medizin
city: Boppard-Bad Salzig
country: Germany
facility: Mittelrhein-Klinik Bad Salzig der DRV
city: Cologne
country: Germany
facility: Klinik für Psychiatrie und Psychotherapie, Universität zu Köln
city: Düsseldorf
country: Germany
facility: Facharztpraxis, Dr. Frosch
city: Düsseldorf
country: Germany
facility: Facharztpraxis Dr. Kuhlbusch
city: Düsseldorf
country: Germany
facility: LVR-Klinikum Düsseldorf - Kliniken der Heinrich-Heine Universität
city: Göttingen
country: Germany
facility: Klinik für Psychiatrie und Psychotherapie, Uniklinik Göttingen
city: Hamburg
country: Germany
facility: Klinik für Psychiatrie und Psychotherapie, UKE
city: Hennigsdorf
country: Germany
facility: Oberhavel Kliniken Hennigsdorf
city: Löhne
country: Germany
facility: Berolina Klinik
city: Marburg
country: Germany
facility: Klinik für Psychiatrie und Psychotherapie der Uniklinik Marburg
city: Munich
country: Germany
facility: Klinik für Psychiatrie und Psychotherapie, LMU
city: Teltow
country: Germany
facility: Reha-Zentrum Seehof der DRV
city: Tübingen
country: Germany
facility: Psychiatrisch-psychotherapeutisches Rehabilitationszentrum grund.stein
city: Tübingen
country: Germany
facility: Klinik für Psychiatrie und Psychotherapie
city: Waren (Müritz)
country: Germany
facility: AHG Klinik Waren
Study officials:
affiliation: LVR-Klinikum Düsseldorf Kliniken der Heinrich-Heine-Universität Düsseldorf
name: Wolfgang Gaebel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Corrigan P, Lundin R. Don´t call me nuts: Coping with the stigma of mental illness. Recovery Press, Chicago 2001
citation: 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
citation: 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.
citation: Gaebel W, Zäske H, Baumann A (2004) Stigma erschwert Behandlung und Integration. Dtsch Ärztebl 101: A3253-3255
citation: 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.
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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
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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
citation: 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.
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citation: 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.
citation: 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.
citation: Rüesch P. Soziale Netzwerke und Lebensqualität. In: Gaebel W, Möller HJ, Rössler W (Hrsg). Stigma - Diskriminierung - Bewältigung. Kohlhammer, Stuttgart 2005
citation: Sartorius N, Schulze H. Reducing the stigma of mental illness. Cambridge University Press, Cambridge 2005
citation: 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.
citation: 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.
citation: 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.