Clinical trial NCT03218748: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mental Illness
Keywords: Mental illness
Disclosure
stigma
soldiers
secrecy
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: Center for Military Mental Health, Berlin, Germany
name: Illinois Institute of Technology, Chicago, USA
First posted: 2017-07-17
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Stigma Stress Scale, 8 items
timeFrame: 3 weeks (T1)
measure: WHOQoL BREF; Domain psychological quality of life, 6 items
timeFrame: 6 weeks (T2)
Secondary outcomes:
measure: Empowerment Scale, Subscale 'Self-esteem', 9 items
timeFrame: baseline, 3, 6 and 12 weeks (T3)
measure: Psychological Well-Being Scale, 18 items
timeFrame: baseline, 3, 6 and 12 weeks
measure: Internalized Stigma of Mental Illness Inventory, Brief Version, 10 items
timeFrame: baseline, 3, 6 and 12 weeks
measure: Self-Stigma of Mental Illness Scale, Short Version, subscale Self-Concurrence, 5 items
timeFrame: baseline, 3, 6 and 12 weeks
measure: Secrecy and Social Withdrawal subscales of the Stigma Coping Orientation Scales, 12 items
timeFrame: baseline, 3, 6 and 12 weeks
measure: 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)
timeFrame: baseline, 3, 6 and 12 weeks
measure: WHOQoL-BREF, 26 items
timeFrame: 3, 6 and 12 weeks
measure: Patient Health Questionnaire (PHQ-9), 9 items
timeFrame: baseline, 3, 6 and 12 weeks
measure: Shame about having a mental illness, 1 item
timeFrame: baseline, 3, 6 and 12 weeks
measure: Attitudes to help-seeking, 2 items
timeFrame: baseline, 3, 6 and 12 weeks
measure: Attitudes to disclosure, 2 items
timeFrame: baseline, 3, 6 and 12 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Illinois Institute of Technology
state: Illinois
city: Berlin
country: Germany
facility: Center for Military Mental Health
city: Ulm
country: Germany
facility: Department of Psychiatry II, Section Pubic Mental Health, Ulm University, Bezirkskrankenhaus Günzburg
Study officials:
affiliation: Department of Psychiatry II, Section Public Mental Health, Ulm University, Bezirkskrankenhaus Günzburg
name: Nicolas Rüsch, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Military Mental Health, Berlin, Germany
name: Gerd-Dieter Willmund, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Military Mental Health, Berlin, Germany
name: Peter Zimmermann, Dr.
role: PRINCIPAL_INVESTIGATOR
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