Depression Clinical Trial
— STEMOfficial title:
Group Intervention for Improving Stigma Coping and Empowerment of People With Mental Illness (STEM)
Verified date | June 2016 |
Source | Heinrich-Heine University, Duesseldorf |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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) |
Lead Sponsor | Collaborator |
---|---|
Wolfgang Gaebel, Professor | German Federal Ministry of Education and Research |
Germany,
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
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 |
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