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Honest, Open, Proud for Soldiers With Mental Illness

Primary Purpose

Mental Illness

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Honest, Open, Proud (HOP)
Sponsored by
University of Ulm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Illness focused on measuring Mental illness, Disclosure, stigma, soldiers, secrecy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • 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

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

Sites / Locations

  • Illinois Institute of Technology
  • Center for Military Mental HealthRecruiting
  • Department of Psychiatry II, Section Pubic Mental Health, Ulm University, Bezirkskrankenhaus Günzburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Honest, Open, Proud

Control group

Arm Description

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

Treatment as usual (TAU)

Outcomes

Primary Outcome Measures

Stigma Stress Scale, 8 items
(Rüsch et al. 2009a; Rüsch et al. 2009b)
WHOQoL BREF; Domain psychological quality of life, 6 items
(WHOQoL Group 1998)

Secondary Outcome Measures

Empowerment Scale, Subscale 'Self-esteem', 9 items
(Rogers et al. 1997)
Psychological Well-Being Scale, 18 items
(Ryff 1989)
Internalized Stigma of Mental Illness Inventory, Brief Version, 10 items
(Boyd et al. 2014)
Self-Stigma of Mental Illness Scale, Short Version, subscale Self-Concurrence, 5 items
(Corrigan et al. 2012)
Secrecy and Social Withdrawal subscales of the Stigma Coping Orientation Scales, 12 items
(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)
(Rüsch et al. 2014a)
WHOQoL-BREF, 26 items
(WHOQOL Group 1998)
Patient Health Questionnaire (PHQ-9), 9 items
(Kroenke et al. 2001)
Shame about having a mental illness, 1 item
(Rüsch et al. 2014b)
Attitudes to help-seeking, 2 items
(Rüsch et al. 2013)
Attitudes to disclosure, 2 items
(Rüsch et al. 2011)

Full Information

First Posted
July 12, 2017
Last Updated
December 1, 2020
Sponsor
University of Ulm
Collaborators
Center for Military Mental Health, Berlin, Germany, Illinois Institute of Technology, Chicago, USA
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1. Study Identification

Unique Protocol Identification Number
NCT03218748
Brief Title
Honest, Open, Proud for Soldiers With Mental Illness
Official Title
Adaptation and Evaluation of the Honest, Open, Proud Program for Soldiers With Mental Illness
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulm
Collaborators
Center for Military Mental Health, Berlin, Germany, Illinois Institute of Technology, Chicago, USA

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Illness
Keywords
Mental illness, Disclosure, stigma, soldiers, secrecy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Honest, Open, Proud
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Treatment as usual (TAU)
Intervention Type
Behavioral
Intervention Name(s)
Honest, Open, Proud (HOP)
Other Intervention Name(s)
Coming Out Proud (COP)
Intervention Description
Three lessons, one for each two-hour session plus one booster session 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 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 Telling one's story: Practice how to tell one's story, identifying peers who might be helpful with the coming out process Booster session Reviewing previous intentions to disclose one's mental illness, discussion whether one disclosed and evaluating this experience
Primary Outcome Measure Information:
Title
Stigma Stress Scale, 8 items
Description
(Rüsch et al. 2009a; Rüsch et al. 2009b)
Time Frame
3 weeks (T1)
Title
WHOQoL BREF; Domain psychological quality of life, 6 items
Description
(WHOQoL Group 1998)
Time Frame
6 weeks (T2)
Secondary Outcome Measure Information:
Title
Empowerment Scale, Subscale 'Self-esteem', 9 items
Description
(Rogers et al. 1997)
Time Frame
baseline, 3, 6 and 12 weeks (T3)
Title
Psychological Well-Being Scale, 18 items
Description
(Ryff 1989)
Time Frame
baseline, 3, 6 and 12 weeks
Title
Internalized Stigma of Mental Illness Inventory, Brief Version, 10 items
Description
(Boyd et al. 2014)
Time Frame
baseline, 3, 6 and 12 weeks
Title
Self-Stigma of Mental Illness Scale, Short Version, subscale Self-Concurrence, 5 items
Description
(Corrigan et al. 2012)
Time Frame
baseline, 3, 6 and 12 weeks
Title
Secrecy and Social Withdrawal subscales of the Stigma Coping Orientation Scales, 12 items
Description
(Link et al. 1991)
Time Frame
baseline, 3, 6 and 12 weeks
Title
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)
Description
(Rüsch et al. 2014a)
Time Frame
baseline, 3, 6 and 12 weeks
Title
WHOQoL-BREF, 26 items
Description
(WHOQOL Group 1998)
Time Frame
3, 6 and 12 weeks
Title
Patient Health Questionnaire (PHQ-9), 9 items
Description
(Kroenke et al. 2001)
Time Frame
baseline, 3, 6 and 12 weeks
Title
Shame about having a mental illness, 1 item
Description
(Rüsch et al. 2014b)
Time Frame
baseline, 3, 6 and 12 weeks
Title
Attitudes to help-seeking, 2 items
Description
(Rüsch et al. 2013)
Time Frame
baseline, 3, 6 and 12 weeks
Title
Attitudes to disclosure, 2 items
Description
(Rüsch et al. 2011)
Time Frame
baseline, 3, 6 and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas Rüsch, Dr.
Phone
+49 731 500-62300
Email
nicolas.ruesch@uni-ulm.de
First Name & Middle Initial & Last Name or Official Title & Degree
Gerd-Dieter Willmund, Dr.
Phone
+49 30 2841-1690
Email
GerdDieterWillmund@bundeswehr.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Rüsch, Dr.
Organizational Affiliation
Department of Psychiatry II, Section Public Mental Health, Ulm University, Bezirkskrankenhaus Günzburg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerd-Dieter Willmund, Dr.
Organizational Affiliation
Center for Military Mental Health, Berlin, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Zimmermann, Dr.
Organizational Affiliation
Center for Military Mental Health, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Illinois Institute of Technology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Center for Military Mental Health
City
Berlin
ZIP/Postal Code
10115
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerd-Dieter Willmund, Dr.
Phone
+49 30 2841-1690
Email
GerdDieterWillmund@bundeswehr.org
Facility Name
Department of Psychiatry II, Section Pubic Mental Health, Ulm University, Bezirkskrankenhaus Günzburg
City
Ulm
ZIP/Postal Code
89073
Country
Germany
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9255837
Citation
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.
Results Reference
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24660946
Citation
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Results Reference
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22578819
Citation
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.
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Citation
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Citation
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Citation
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Citation
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Honest, Open, Proud for Soldiers With Mental Illness

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