NCT01655368

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
486

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started May 2012

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 14, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 15, 2016

Status Verified

June 1, 2016

Enrollment Period

3.1 years

First QC Date

June 14, 2012

Last Update Submit

June 14, 2016

Conditions

SchizophreniaDepression

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • self-stigma (ISMI)

    after 6 weeks, 6 months, 12 months

  • empowerment (BUES)

    after 6 weeks, 6 months, 12 months

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

    after 6 weeks, 6 months, 12 months

Study Arms (2)

Interventional: STEM modules

EXPERIMENTAL

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

Behavioral: psychotherapeutic STEM modules

Interventional Control

OTHER

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

Behavioral: Interventional control of normal psychoeducational treatment

Interventions

psychotherapeutic STEM modulesBEHAVIORAL

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

Interventional: STEM modules
Interventional control of normal psychoeducational treatmentBEHAVIORAL

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

Interventional Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • insufficient knowledge of german language (reading, understanding and speaking not sufficient, as judged by the investigator)
  • acute psychotic or dissociative condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Klinik für Psychiatrie und Psychotherapie der RWTH

Aachen, 52074, Germany

Location

Facharztpraxis Dr. Mönter

Berlin, 10589, Germany

Location

Facharztpraxis Gereke

Berlin, 10589, Germany

Location

Facharztpraxis Alicia Navarro Urena

Berlin, 12203, Germany

Location

MediClin Bliestal Kliniken, Fachklinik für psychosomatische Medizin

Blieskastel, 66440, Germany

Location

Mittelrhein-Klinik Bad Salzig der DRV

Boppard-Bad Salzig, 56154, Germany

Location

Klinik für Psychiatrie und Psychotherapie, Universität zu Köln

Cologne, 50937, Germany

Location

Facharztpraxis, Dr. Frosch

Düsseldorf, 40211, Germany

Location

Facharztpraxis Dr. Kuhlbusch

Düsseldorf, 40227, Germany

Location

LVR-Klinikum Düsseldorf - Kliniken der Heinrich-Heine Universität

Düsseldorf, 40629, Germany

Location

Klinik für Psychiatrie und Psychotherapie, Uniklinik Göttingen

Göttingen, 37075, Germany

Location

Klinik für Psychiatrie und Psychotherapie, UKE

Hamburg, 20246, Germany

Location

Oberhavel Kliniken Hennigsdorf

Hennigsdorf, 16761, Germany

Location

Berolina Klinik

Löhne, 32584, Germany

Location

Klinik für Psychiatrie und Psychotherapie der Uniklinik Marburg

Marburg, 35039, Germany

Location

Klinik für Psychiatrie und Psychotherapie, LMU

Munich, 80336, Germany

Location

Reha-Zentrum Seehof der DRV

Teltow, 14513, Germany

Location

Psychiatrisch-psychotherapeutisches Rehabilitationszentrum grund.stein

Tübingen, 72072, Germany

Location

Klinik für Psychiatrie und Psychotherapie

Tübingen, 72076, Germany

Location

AHG Klinik Waren

Waren, 17192, Germany

Location

Related Publications (20)

  • 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.

    PMID: 17139037BACKGROUND

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

    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

    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.

    PMID: 14674047BACKGROUND

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

    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.

    PMID: 17961985BACKGROUND

  • 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.

    PMID: 17087669BACKGROUND

  • 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

    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.

    PMID: 11726753BACKGROUND

  • 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.

    PMID: 16894025BACKGROUND

  • 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

    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.

    PMID: 11726754BACKGROUND

  • 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.

    PMID: 14572622BACKGROUND

  • 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.

    PMID: 15661319BACKGROUND

  • 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.

    PMID: 19949209BACKGROUND

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

    BACKGROUND

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

    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.

    PMID: 11726752BACKGROUND

  • 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.

    PMID: 17255118BACKGROUND

  • 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.

    PMID: 31520149DERIVED

Related Links

MeSH Terms

Conditions

SchizophreniaDepression

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Wolfgang Gaebel, Prof. Dr.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor Dr.

Study Record Dates

First Submitted

June 14, 2012

First Posted

August 1, 2012

Study Start

May 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 15, 2016

Record last verified: 2016-06

Locations

DE(20)