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Trial record 2 of 20581 for:    mental illness

Honest, Open, Proud for Soldiers With Mental Illness

This study is currently recruiting participants.
Verified November 2017 by Nicolas Rüsch, University of Ulm
Sponsor:
ClinicalTrials.gov Identifier:
NCT03218748
First Posted: July 17, 2017
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Center for Military Mental Health, Berlin, Germany
Illinois Institute of Technology, Chicago, USA
Information provided by (Responsible Party):
Nicolas Rüsch, University of Ulm
  Purpose
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.

Condition Intervention
Mental Illness Behavioral: Honest, Open, Proud (HOP)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adaptation and Evaluation of the Honest, Open, Proud Program for Soldiers With Mental Illness

Resource links provided by NLM:


Further study details as provided by Nicolas Rüsch, University of Ulm:

Primary Outcome Measures:
  • Stigma Stress Scale, 8 items [ Time Frame: 3 weeks (T1) ]
    (Rüsch et al. 2009a; Rüsch et al. 2009b)

  • WHOQoL BREF; Domain psychological quality of life, 6 items [ Time Frame: 6 weeks (T2) ]
    (WHOQoL Group 1998)


Secondary Outcome Measures:
  • Empowerment Scale, Subscale 'Self-esteem', 9 items [ Time Frame: baseline, 3, 6 and 12 weeks (T3) ]
    (Rogers et al. 1997)

  • Psychological Well-Being Scale, 18 items [ Time Frame: baseline, 3, 6 and 12 weeks ]
    (Ryff 1989)

  • Internalized Stigma of Mental Illness Inventory, Brief Version, 10 items [ Time Frame: baseline, 3, 6 and 12 weeks ]
    (Boyd et al. 2014)

  • Self-Stigma of Mental Illness Scale, Short Version, subscale Self-Concurrence, 5 items [ Time Frame: baseline, 3, 6 and 12 weeks ]
    (Corrigan et al. 2012)

  • Secrecy and Social Withdrawal subscales of the Stigma Coping Orientation Scales, 12 items [ Time Frame: baseline, 3, 6 and 12 weeks ]
    (Link et al. 1991)

  • Disclosure related distress ("In general, how distressed or worried are you in terms of secrecy or disclosure of your mental illness to others?', from 1, not at all, to 7, very much) [ Time Frame: baseline, 3, 6 and 12 weeks ]
    (Rüsch et al. 2014a)

  • WHOQoL-BREF, 26 items [ Time Frame: 3, 6 and 12 weeks ]
    (WHOQOL Group 1998)

  • Patient Health Questionnaire (PHQ-9), 9 items [ Time Frame: baseline, 3, 6 and 12 weeks ]
    (Kroenke et al. 2001)

  • Shame about having a mental illness, 1 item [ Time Frame: baseline, 3, 6 and 12 weeks ]
    (Rüsch et al. 2014b)

  • Attitudes to help-seeking, 2 items [ Time Frame: baseline, 3, 6 and 12 weeks ]
    (Rüsch et al. 2013)

  • Attitudes to disclosure, 2 items [ Time Frame: baseline, 3, 6 and 12 weeks ]
    (Rüsch et al. 2011)


Estimated Enrollment: 100
Anticipated Study Start Date: November 2017
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Honest, Open, Proud

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)

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
Other Name: Coming Out Proud (COP)
No Intervention: Control group
Treatment as usual (TAU)

Detailed Description:

Soldiers with mental illness typically face a two-fold problem. On the one hand, they have to cope with the symptoms of their mental illness; on the other hand, they often have to deal with stigma and discrimination. Both due to fear of public stigma and due to self-stigma or shame, soldiers with mental illness may decide to keep their condition a secret or even to withdraw from other people altogether in order to minimize the risk of being labeled. Secrecy can help on the short term to protect individuals from public stigma, but usually it has negative long-term consequences such as social isolation, distress and avoidance of help-seeking. Disclosure, on the other hand, carries the risk to be discriminated by others, but can reduce the burden of secrecy, lead to support by others and reduce public stigma.

In this study investigators aim to test the efficacy (see our outcomes above) of Honest, Open, Proud run by soldiers with lived experience of mental illness.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218748


Contacts
Contact: Nicolas Rüsch, Dr. +49 731 500-62300 nicolas.ruesch@uni-ulm.de
Contact: Gerd-Dieter Willmund, Dr. +49 30 2841-1690 GerdDieterWillmund@bundeswehr.org

Locations
United States, Illinois
Illinois Institute of Technology Active, not recruiting
Chicago, Illinois, United States, 60616
Germany
Center for Military Mental Health Recruiting
Berlin, Germany, 10115
Contact: Gerd-Dieter Willmund, Dr.    +49 30 2841-1690    GerdDieterWillmund@bundeswehr.org   
Department of Psychiatry II, Section Pubic Mental Health, Ulm University, Bezirkskrankenhaus Günzburg Active, not recruiting
Ulm, Germany, 89073
Sponsors and Collaborators
University of Ulm
Center for Military Mental Health, Berlin, Germany
Illinois Institute of Technology, Chicago, USA
Investigators
Principal Investigator: 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
  More Information

Publications:
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.

Responsible Party: Nicolas Rüsch, Professor, University of Ulm
ClinicalTrials.gov Identifier: NCT03218748     History of Changes
Other Study ID Numbers: HOP Soldiers
First Submitted: July 12, 2017
First Posted: July 17, 2017
Last Update Posted: November 8, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nicolas Rüsch, University of Ulm:
Mental illness
Disclosure
stigma
soldiers
secrecy

Additional relevant MeSH terms:
Mental Disorders