NCT03218748

Brief Summary

The purpose of the study is to evaluate the feasibility and efficacy of the group-based intervention "Honest, Open, Proud" among soldiers with mental illness.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 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

First Submitted

Initial submission to the registry

July 12, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 17, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

November 15, 2017

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

6.9 years

First QC Date

July 12, 2017

Last Update Submit

December 5, 2024

Conditions

Keywords

Mental illnessDisclosurestigmasoldierssecrecy

Outcome Measures

Primary Outcomes (2)

  • Stigma Stress Scale, 8 items

    (Rüsch et al. 2009a; Rüsch et al. 2009b)

    3 weeks (T1)

  • WHOQoL BREF; Domain psychological quality of life, 6 items

    (WHOQoL Group 1998)

    6 weeks (T2)

Secondary Outcomes (11)

  • Empowerment Scale, Subscale 'Self-esteem', 9 items

    baseline, 3, 6 and 12 weeks (T3)

  • Psychological Well-Being Scale, 18 items

    baseline, 3, 6 and 12 weeks

  • Internalized Stigma of Mental Illness Inventory, Brief Version, 10 items

    baseline, 3, 6 and 12 weeks

  • Self-Stigma of Mental Illness Scale, Short Version, subscale Self-Concurrence, 5 items

    baseline, 3, 6 and 12 weeks

  • Secrecy and Social Withdrawal subscales of the Stigma Coping Orientation Scales, 12 items

    baseline, 3, 6 and 12 weeks

  • +6 more secondary outcomes

Study Arms (2)

Honest, Open, Proud

EXPERIMENTAL

The group program is about disclosure versus secrecy of one's mental illness. The groups are facilitated by two peers (soldiers with lived experience of mental illness). Each group runs for three weeks, one meeting per week, and two hours per meeting. There is one 2-hour booster session in week 6. Fidelity to manual: rated by a research assistant who is present during the group session

Behavioral: Honest, Open, Proud (HOP)

Control group

NO INTERVENTION

Treatment as usual (TAU)

Interventions

Three lessons, one for each two-hour session plus one booster session 1. Considering the pros and cons of disclosure: Discussion of one's idea of identity and mental illness, weighing the costs and benefits of (non-) disclosure 2. Different ways to disclose: Discussion of different levels of (non-) disclosure, considering costs and benefits of each level, selecting persons to disclose to and how to test them out, anticipating responses of others to one's disclosure 3. Telling one's story: Practice how to tell one's story, identifying peers who might be helpful with the coming out process 4. Booster session Reviewing previous intentions to disclose one's mental illness, discussion whether one disclosed and evaluating this experience

Also known as: Coming Out Proud (COP)
Honest, Open, Proud

Eligibility Criteria

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

You may qualify if:

  • At least one self-reported current axis I or axis II disorder according to DSM-5, which is not restricted to only substance-related disorder(s)
  • Age 18 or above
  • Ability to provide written informed consent
  • Fluent in German (needed for self-report measures)
  • At least a moderate level of self-reported disclosure-related distress/difficulty (score 4 or higher on the screening item 'In general, how distressed or worried are you in terms of secrecy or disclosure of your mental illness to others?', rated from 1, not at all, to 7, very much)
  • Current inpatient, day-clinic or outpatient treatment at the Center for Military Mental Health, Berlin, Germany
  • from April 2018 onwards we decided to also include non-military first responders (fire fighters or police officers) who are treated in the Center for Military Mental Health, Berlin, Germany

You may not qualify if:

  • Self-reported diagnosis of only a substance- or alcohol-related disorder, without non-substance related current psychiatric comorbidity. We will exclude people who only have a substance-/alcohol-related disorder because the disclosure of these disorders is not the topic of the HOP intervention
  • Intellectual disability
  • Organic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Illinois Institute of Technology

Chicago, Illinois, 60616, United States

Location

Center for Military Mental Health

Berlin, 10115, Germany

Location

Department of Psychiatry II, Section Pubic Mental Health, Ulm University, Bezirkskrankenhaus Günzburg

Ulm, 89073, Germany

Location

Related Publications (14)

  • Rogers ES, Chamberlin J, Ellison ML, Crean T. A consumer-constructed scale to measure empowerment among users of mental health services. Psychiatr Serv. 1997 Aug;48(8):1042-7. doi: 10.1176/ps.48.8.1042.

    PMID: 9255837BACKGROUND
  • Boyd JE, Otilingam PG, Deforge BR. Brief version of the Internalized Stigma of Mental Illness (ISMI) scale: psychometric properties and relationship to depression, self esteem, recovery orientation, empowerment, and perceived devaluation and discrimination. Psychiatr Rehabil J. 2014 Mar;37(1):17-23. doi: 10.1037/prj0000035.

    PMID: 24660946BACKGROUND
  • Corrigan PW, Michaels PJ, Vega E, Gause M, Watson AC, Rusch N. Self-stigma of mental illness scale--short form: reliability and validity. Psychiatry Res. 2012 Aug 30;199(1):65-9. doi: 10.1016/j.psychres.2012.04.009. Epub 2012 May 10.

    PMID: 22578819BACKGROUND
  • Rusch N, Abbruzzese E, Hagedorn E, Hartenhauer D, Kaufmann I, Curschellas J, Ventling S, Zuaboni G, Bridler R, Olschewski M, Kawohl W, Rossler W, Kleim B, Corrigan PW. Efficacy of Coming Out Proud to reduce stigma's impact among people with mental illness: pilot randomised controlled trial. Br J Psychiatry. 2014;204(5):391-7. doi: 10.1192/bjp.bp.113.135772. Epub 2014 Jan 16.

    PMID: 24434073BACKGROUND
  • Link BG, Mirotznik J, Cullen FT. The effectiveness of stigma coping orientations: can negative consequences of mental illness labeling be avoided? J Health Soc Behav. 1991 Sep;32(3):302-20.

    PMID: 1940212BACKGROUND
  • Rusch N, Corrigan PW, Heekeren K, Theodoridou A, Dvorsky D, Metzler S, Muller M, Walitza S, Rossler W. Well-being among persons at risk of psychosis: the role of self-labeling, shame, and stigma stress. Psychiatr Serv. 2014 Apr 1;65(4):483-9. doi: 10.1176/appi.ps.201300169.

    PMID: 24382666BACKGROUND
  • Rusch N, Heekeren K, Theodoridou A, Dvorsky D, Muller M, Paust T, Corrigan PW, Walitza S, Rossler W. Attitudes towards help-seeking and stigma among young people at risk for psychosis. Psychiatry Res. 2013 Dec 30;210(3):1313-5. doi: 10.1016/j.psychres.2013.08.028. Epub 2013 Sep 4.

    PMID: 24012162BACKGROUND
  • Rusch N, Evans-Lacko SE, Henderson C, Flach C, Thornicroft G. Knowledge and attitudes as predictors of intentions to seek help for and disclose a mental illness. Psychiatr Serv. 2011 Jun;62(6):675-8. doi: 10.1176/ps.62.6.pss6206_0675.

    PMID: 21632739BACKGROUND
  • Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.

    PMID: 9626712BACKGROUND
  • Rusch N, Corrigan PW, Powell K, Rajah A, Olschewski M, Wilkniss S, Batia K. A stress-coping model of mental illness stigma: II. Emotional stress responses, coping behavior and outcome. Schizophr Res. 2009 May;110(1-3):65-71. doi: 10.1016/j.schres.2009.01.005. Epub 2009 Feb 23.

    PMID: 19237266BACKGROUND
  • Rusch N, Corrigan PW, Wassel A, Michaels P, Olschewski M, Wilkniss S, Batia K. A stress-coping model of mental illness stigma: I. Predictors of cognitive stress appraisal. Schizophr Res. 2009 May;110(1-3):59-64. doi: 10.1016/j.schres.2009.01.006. Epub 2009 Mar 6.

    PMID: 19269140BACKGROUND
  • Ryff, C. D. (1989): Happiness is everything, or is it? Explorations on the meaning of psychological well-being. Journal of Personality and Social Psychology (57): 1069-1081.

    BACKGROUND
  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PMID: 11556941BACKGROUND
  • Rusch N, Helms C, Horger J, Hohle B, Bernert H, Muschner P, Rose C, Corrigan PW, Mulfinger N, Zimmermann P, Willmund GD. The peer-led Honest, Open, Proud program to decrease the impact of mental illness stigma among German military personnel: randomized controlled trial. Soc Psychiatry Psychiatr Epidemiol. 2025 Jul 22. doi: 10.1007/s00127-025-02960-x. Online ahead of print.

MeSH Terms

Conditions

Mental DisordersSocial Stigma

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Nicolas Rüsch, Dr.

    Department of Psychiatry II, Section Public Mental Health, Ulm University, Bezirkskrankenhaus Günzburg

    PRINCIPAL INVESTIGATOR
  • Gerd-Dieter Willmund, Dr.

    Center for Military Mental Health, Berlin, Germany

    PRINCIPAL INVESTIGATOR
  • Peter Zimmermann, Dr.

    Center for Military Mental Health, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 12, 2017

First Posted

July 17, 2017

Study Start

November 15, 2017

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

December 11, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations