Mental IllnessNCT03218748
Honest, Open, Proud for Soldiers with Mental Illness
A study testing Honest, Open, Proud (HOP) in people with Mental Illness, run by University of Ulm at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Illness
- What is being tested?
- Honest, Open, Proud (HOP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 15 Nov 2017to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Center for Military Mental Health
Berlin, 10115
Department of Psychiatry II, Section Pubic Mental Health, Ulm University, Bezirkskrankenhaus Günzburg
Ulm, 89073
United States1 site
Illinois Institute of Technology
Chicago, Illinois, 60616
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Illness
- Being tested
- Honest, Open, Proud (HOP)
- Keywords
- Mental illness, Disclosure, stigma, soldiers, secrecy
- Medical subject headings
- Mental Disorders, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Honest, Open, Proud (HOP)Behavioural
Also called Coming Out Proud (COP)
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
| Study group | Role | What they receive |
|---|---|---|
| Honest, Open, Proud | Experimental | 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 Receives: Behavioral: Honest, Open, Proud (HOP) |
| Control group | No intervention | Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stigma Stress Scale, 8 items
(Rüsch et al. 2009a; Rüsch et al. 2009b)
Measured: 3 weeks (T1)
WHOQoL BREF; Domain psychological quality of life, 6 items
(WHOQoL Group 1998)
Measured: 6 weeks (T2)
Secondary outcomes (11)
Empowerment Scale, Subscale 'Self-esteem', 9 items
(Rogers et al. 1997)
Measured: baseline, 3, 6 and 12 weeks (T3)
Psychological Well-Being Scale, 18 items
(Ryff 1989)
Measured: baseline, 3, 6 and 12 weeks
Internalized Stigma of Mental Illness Inventory, Brief Version, 10 items
(Boyd et al. 2014)
Measured: baseline, 3, 6 and 12 weeks
Self-Stigma of Mental Illness Scale, Short Version, subscale Self-Concurrence, 5 items
(Corrigan et al. 2012)
Measured: baseline, 3, 6 and 12 weeks
Secrecy and Social Withdrawal subscales of the Stigma Coping Orientation Scales, 12 items
(Link et al. 1991)
Measured: 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)
(Rüsch et al. 2014a)
Measured: baseline, 3, 6 and 12 weeks
WHOQoL-BREF, 26 items
(WHOQOL Group 1998)
Measured: 3, 6 and 12 weeks
Patient Health Questionnaire (PHQ-9), 9 items
(Kroenke et al. 2001)
Measured: baseline, 3, 6 and 12 weeks
Shame about having a mental illness, 1 item
(Rüsch et al. 2014b)
Measured: baseline, 3, 6 and 12 weeks
Attitudes to help-seeking, 2 items
(Rüsch et al. 2013)
Measured: baseline, 3, 6 and 12 weeks
Attitudes to disclosure, 2 items
(Rüsch et al. 2011)
Measured: baseline, 3, 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start15 Nov 2017
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Mental IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Military Mental Health, Berlin, Germany, Illinois Institute of Technology
- Responsible party
- Principal investigator, Nicolas Rüsch, University of Ulm
- Investigators
- Nicolas Rüsch, Dr., Principal investigator, Department of Psychiatry II, Section Public Mental Health, Ulm University, Bezirkskrankenhaus GünzburgGerd-Dieter Willmund, Dr., Principal investigator, Center for Military Mental Health, Berlin, GermanyPeter Zimmermann, Dr., Principal investigator, Center for Military Mental Health, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218748
- Sponsor's protocol ID
- HOP Soldiers
- Status last verified
- Dec 2024
- First submitted
- 12 Jul 2017
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9255837Boyd 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.
PubMed 24660946Corrigan 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.
PubMed 22578819Rusch 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.
PubMed 24434073Link 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.
PubMed 1940212Rusch 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.
PubMed 24382666Rusch 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.
PubMed 24012162Rusch 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.
PubMed 21632739Development 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.
PubMed 9626712Rusch 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.
PubMed 19237266Rusch 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.
PubMed 19269140Ryff, 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.
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.
PubMed 11556941Rusch N, Helms C, Horger J, Hohle B, Bernert H, Muschner P, Rose C, Corrigan PW, Mulfinger N, Zimmermann P, Willmund GD. The peer-led Honest, Open, Proud program to decrease the impact of mental illness stigma among German military personnel: randomized controlled trial. Soc Psychiatry Psychiatr Epidemiol. 2026 May;61(5):791-801. doi: 10.1007/s00127-025-02960-x. Epub 2025 Jul 22.
PubMed 40696200
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Evaluation of the Honest, Open, Proud Program for Soldiers with Mental Illness
- ClinicalTrials.gov ID
- NCT03218748
- Acronym / sponsor ID
- HOP Soldiers
- Conditions
- Mental Illness
- Keywords
- Mental illness, Disclosure, stigma, soldiers, secrecy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Collaborators
- Center for Military Mental Health, Berlin, Germany, Illinois Institute of Technology
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 17 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Honest, Open, Proud | Experimental | Behavioral: Honest, Open, Proud (HOP)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 |
| Control group | No intervention | –Treatment as usual (TAU) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Honest, Open, Proud (HOP)Also: Coming Out Proud (COP)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 | Behavioural | Honest, Open, Proud |
Primary outcome
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)
11 secondary outcomes
Empowerment Scale, Subscale 'Self-esteem', 9 items
Time frame: baseline, 3, 6 and 12 weeks (T3)
Psychological Well-Being Scale, 18 items
Time frame: baseline, 3, 6 and 12 weeks
Internalized Stigma of Mental Illness Inventory, Brief Version, 10 items
Time frame: 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
Secrecy and Social Withdrawal subscales of the Stigma Coping Orientation Scales, 12 items
Time frame: 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
WHOQoL-BREF, 26 items
Time frame: 3, 6 and 12 weeks
Patient Health Questionnaire (PHQ-9), 9 items
Time frame: baseline, 3, 6 and 12 weeks
Shame about having a mental illness, 1 item
Time frame: baseline, 3, 6 and 12 weeks
Attitudes to help-seeking, 2 items
Time frame: baseline, 3, 6 and 12 weeks
Attitudes to disclosure, 2 items
Time frame: baseline, 3, 6 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Background: PubMed 9255837Rogers 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.
- Background: PubMed 24660946Boyd 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.
- Background: PubMed 22578819Corrigan 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.
- Background: PubMed 24434073Rusch 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.
- Background: PubMed 1940212Link 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.
- Background: PubMed 24382666Rusch 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.
- Background: PubMed 24012162Rusch 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.
- Background: PubMed 21632739Rusch 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.
- Background: PubMed 9626712Development 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.
- Background: PubMed 19237266Rusch 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.
- Background: PubMed 19269140Rusch 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.
- BackgroundRyff, 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Rüsch, Dr. principal investigator
Department of Psychiatry II, Section Public Mental Health, Ulm University, Bezirkskrankenhaus Günzburg
Gerd-Dieter Willmund, Dr. principal investigator
Center for Military Mental Health, Berlin, Germany
Peter Zimmermann, Dr. principal investigator
Center for Military Mental Health, Berlin, Germany
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Honest, Open, Proud (HOP) in people with Mental Illness, run by University of Ulm at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stigma Stress Scale, 8 items (time frame: 3 weeks (T1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03218748, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.