Honest, Open, Proud for Soldiers with Mental Illness

December 5, 2024 updated by: Nicolas Rüsch, University of Ulm

Adaptation and Evaluation of the Honest, Open, Proud Program for Soldiers with Mental Illness

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
99

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Berlin, Germany, 10115
        • Center for Military Mental Health
      • Ulm, Germany, 89073
        • Department of Psychiatry II, Section Pubic Mental Health, Ulm University, Bezirkskrankenhaus Günzburg
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Illinois Institute of Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Coming Out Proud (COP)
No Intervention: Control group
Treatment as usual (TAU)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stigma Stress Scale, 8 items
Time Frame: 3 weeks (T1)
(Rüsch et al. 2009a; Rüsch et al. 2009b)
3 weeks (T1)
WHOQoL BREF; Domain psychological quality of life, 6 items
Time Frame: 6 weeks (T2)
(WHOQoL Group 1998)
6 weeks (T2)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Empowerment Scale, Subscale 'Self-esteem', 9 items
Time Frame: baseline, 3, 6 and 12 weeks (T3)
(Rogers et al. 1997)
baseline, 3, 6 and 12 weeks (T3)
Psychological Well-Being Scale, 18 items
Time Frame: baseline, 3, 6 and 12 weeks
(Ryff 1989)
baseline, 3, 6 and 12 weeks
Internalized Stigma of Mental Illness Inventory, Brief Version, 10 items
Time Frame: baseline, 3, 6 and 12 weeks
(Boyd et al. 2014)
baseline, 3, 6 and 12 weeks
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)
baseline, 3, 6 and 12 weeks
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)
baseline, 3, 6 and 12 weeks
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)
baseline, 3, 6 and 12 weeks
WHOQoL-BREF, 26 items
Time Frame: 3, 6 and 12 weeks
(WHOQOL Group 1998)
3, 6 and 12 weeks
Patient Health Questionnaire (PHQ-9), 9 items
Time Frame: baseline, 3, 6 and 12 weeks
(Kroenke et al. 2001)
baseline, 3, 6 and 12 weeks
Shame about having a mental illness, 1 item
Time Frame: baseline, 3, 6 and 12 weeks
(Rüsch et al. 2014b)
baseline, 3, 6 and 12 weeks
Attitudes to help-seeking, 2 items
Time Frame: baseline, 3, 6 and 12 weeks
(Rüsch et al. 2013)
baseline, 3, 6 and 12 weeks
Attitudes to disclosure, 2 items
Time Frame: baseline, 3, 6 and 12 weeks
(Rüsch et al. 2011)
baseline, 3, 6 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Ulm

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Center for Military Mental Health, Berlin, Germany
Illinois Institute of Technology, Chicago, USA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HOP Soldiers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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