Honest, Open, Proud for Soldiers With Mental Illness

Mental Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03218748
• Other study ID #: HOP Soldiers
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2017
• Est. completion date: June 1, 2024

Study information

• Verified date: November 2023
• Source: University of Ulm
• Contact: Nicolas Rüsch, Dr.
• Phone: +49 731 500-62300
• Email: nicolas.ruesch[@]uni-ulm.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Mental Illness

Intervention

Behavioral:
• Honest, Open, Proud (HOP)
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

Locations

Country	Name	City	State
Germany	Center for Military Mental Health	Berlin
Germany	Department of Psychiatry II, Section Pubic Mental Health, Ulm University, Bezirkskrankenhaus Günzburg	Ulm
United States	Illinois Institute of Technology	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Ulm	Center for Military Mental Health, Berlin, Germany, Illinois Institute of Technology, Chicago, USA

Countries where clinical trial is conducted

United States,  Germany, 

References & Publications (13)

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stigma Stress Scale, 8 items	(Rüsch et al. 2009a; Rüsch et al. 2009b)	3 weeks (T1)
Primary	WHOQoL BREF; Domain psychological quality of life, 6 items	(WHOQoL Group 1998)	6 weeks (T2)
Secondary	Empowerment Scale, Subscale 'Self-esteem', 9 items	(Rogers et al. 1997)	baseline, 3, 6 and 12 weeks (T3)
Secondary	Psychological Well-Being Scale, 18 items	(Ryff 1989)	baseline, 3, 6 and 12 weeks
Secondary	Internalized Stigma of Mental Illness Inventory, Brief Version, 10 items	(Boyd et al. 2014)	baseline, 3, 6 and 12 weeks
Secondary	Self-Stigma of Mental Illness Scale, Short Version, subscale Self-Concurrence, 5 items	(Corrigan et al. 2012)	baseline, 3, 6 and 12 weeks
Secondary	Secrecy and Social Withdrawal subscales of the Stigma Coping Orientation Scales, 12 items	(Link et al. 1991)	baseline, 3, 6 and 12 weeks
Secondary	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)	baseline, 3, 6 and 12 weeks
Secondary	WHOQoL-BREF, 26 items	(WHOQOL Group 1998)	3, 6 and 12 weeks
Secondary	Patient Health Questionnaire (PHQ-9), 9 items	(Kroenke et al. 2001)	baseline, 3, 6 and 12 weeks
Secondary	Shame about having a mental illness, 1 item	(Rüsch et al. 2014b)	baseline, 3, 6 and 12 weeks
Secondary	Attitudes to help-seeking, 2 items	(Rüsch et al. 2013)	baseline, 3, 6 and 12 weeks
Secondary	Attitudes to disclosure, 2 items	(Rüsch et al. 2011)	baseline, 3, 6 and 12 weeks