Secrecy Versus Disclosure Among Adolescents With Mental IllnessPhase 2NCT02751229
Honest Open Proud for Adolescents With Mental Illness
A Phase 2 study testing Honest Open Proud (HOP) in people with Secrecy Versus Disclosure Among Adolescents With Mental Illness, run by University of Ulm at 5 sites in 2 countries.
Trial summary
The purpose of the study is to evaluate the efficacy of the group-based intervention 'Honest Open Proud' among adolescents with mental illness. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Secrecy Versus Disclosure Among Adolescents With 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
- 100 participants
- Where
- 5 sitesin 2 countries
- Study dates
- May 2016to May 2017
- Phase
- Phase 2
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- At least one self-reported current axis I or axis II disorder according to DSM-5 (American Psychiatric Association, 2013), which is not restricted to only substance-related disorder(s)
- Age 13 to 18
- Ability to provide written informed consent
- Fluid 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)
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
5 sites in 2 countries.
5 sites in 2 countries
Germany4 sites
Josefinum, Child and Adolescent Psychiatry and Psychotherapy
Augsburg
Department of Psychiatry II, Section Public Mental Health, Ulm University, Bezirkskrankenhaus Günzburg
Ulm, 89073
Child and Adolescent Psychiatry and Psychotherapy, University of Ulm
Ulm
Child and Adolescent Psychiatry Weissenau, Centre for Psychiatry in South-Württemberg
Weißenau
About this study
Official title: Adaptation and Evaluation of the Honest Open Proud Program for Adolescents With Mental Illness
The purpose of the study is to evaluate the efficacy of the group-based intervention 'Honest Open Proud' among adolescents with mental illness.
Read the detailed description
Both due to fear of public stigma and due to self-stigma or shame, people with mental illness may decide to keep their condition a secret or even to withdraw from other people altogether in order to minimise the risk of being labelled. Secrecy can help on the short term to protect individuals from public stigma, but often it has negative long-term consequences such as social isolation, distress and unemployment. 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 evaluate whether a group program run both by people with mental illness (peers) and professionals helps to reduce self-stigma and makes it easier for adolescents to handle the necessary choices related to secrecy versus disclosure.
- Being tested
- Honest Open Proud (HOP)
- Keywords
- Mental illness, adolescents, intervention, stigma, disclosure, 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)
five lessons in three modules, two for each two-hour session
- Considering pros and cons of disclosing:
- hurtful and helpful attitudes about mental illness
- identify beliefs participants hold about themselves
- explore five-step process to challenge their personally hurtful beliefs
- weigh pros and cons of coming out in order to facilitate a decision on whether to disclose
- Different ways to disclose:
- different levels of (non-) disclosure and how to weigh the cons and pros
- disclosure via social media versus disclosing face to face
- how to find people that are better to disclose to than others and how to 'test them out'
- participants will discuss how others might respond to their disclosure and how that will affect them
- Telling your story:
- how to tell one's story in a personally meaningful way, how to identify peers who might help with the coming out process, to review how telling one's story felt
| Study group | Role | What they receive |
|---|---|---|
| Honest Open Proud | Experimental | The group program is about disclosure ('coming out') versus secrecy of one's mental illness. The groups are facilitated by peers (young adults with mental illness) and mental health professionals. Each group runs for three weeks, one meeting per week, and two hours per meeting.
Fidelity to manual: rated by PhD student in each session as proportion of key topics covered 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, Corrigan, Wassel et al., 2009; Rüsch, Corrigan, Powell et al., 2009)
Measured: 3 weeks (T1)
Health-Related Quality of Life Questionnaire KIDSCREEN-10 Index, 10 items (Deighton et al., 2014; Ravens-Sieberer et al., 2010)
Measured: 6 weeks (T2)
Secondary outcomes (11)
Satisfaction with intervention questionnaire (according to Keller, Konopka, Fegert, & Naumann, 2003; own development)
Measured: 3 weeks
Empowerment Scale, Subscales 'self-esteem' and 'control over the future', 13 items (Rogers, Chamberlin, Ellison, & Crean, 1997)
Measured: baseline, 3 and 6 weeks
Attitudes to disclosure, 2 items (Rüsch, Evans-Lacko, Henderson, Flach, & Thornicroft, 2011)
2 items on attitudes to disclosure, adapted from a UK Dept of Health survey (see above Rüsch et al 2011 reference for further details) with seven-point Likert scale
Measured: baseline, 3 and 6 weeks
Disclosure Distress, 1 item ("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 and 6 weeks
Shame about having a mental illness, 1 item ("Do you feel ashamed about having a mental illness?"; from 1, not at all, to 7, very much) (Rüsch et al., 2014b)
Measured: baseline, 3 and 6 weeks
General Help-Seeking Questionnaire, 1 item (Wilson et al., 2005)
Measured: baseline, 3 and 6 weeks
Beck Hopelessness Scale (BHS), 4-item short version (Yip, Paul S F & Cheung, 2006)
Measured: baseline, 3 and 6 weeks
Self-Stigma of Mental Illness Scale (SSMIS), Subscale 'self-concurrence', 5 items (Corrigan et al., 2012; Rüsch et al., 2006)
Measured: baseline, 3 and 6 weeks
Self-Identified Stage of Recovery (SISR), 5 items (Andresen, Caputi, & Oades, 2010)
brief self-rated assessment of stage of recovery; consists of two parts (A \& B): Part A reflects five statements about stages of recovery, participants have to choose one that best reflects their current experience. Part B consists of four statements reflecting recovery processes, rated on a six-point Likert scale
Measured: baseline, 3 and 6 weeks
Internalised Stigma of Mental Illness Inventory (ISMI), 10-item short version (Boyd, Otilingam, & Deforge, 2014)
Measured: baseline, 3 and 6 weeks
Social withdrawal and secrecy, 12 item-short version (Link et al., 2009)
Measured: baseline, 3 and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Secrecy Versus Disclosure Among Adolescents With 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- Child and Adolescent Psychiatry Weissenau, Centre for Psychiatry in South-Württemberg, Germany, Josefinum, Child and Adolescent Psychiatry and Psychotherapy, Augsburg, Germany, Illinois Institute of Technology
- Responsible party
- Principal investigator, Nicolas Rüsch, University of Ulm
- Investigators
- Nicolas Rüsch, Professor, Principal investigator, Department of Psychiatry II, Section Public Mental Health, Ulm University, Bezirkskrankenhaus Günzburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751229
- Sponsor's protocol ID
- HOP-Adolescents
- Status last verified
- Mar 2017
- First submitted
- 24 Mar 2016
- Last updated
- 9 May 2017
- Results posted
- No
Publications
Andresen R, Caputi P, Oades LG. Do clinical outcome measures assess consumer-defined recovery? Psychiatry Res. 2010 May 30;177(3):309-17. doi: 10.1016/j.psychres.2010.02.013. Epub 2010 Mar 15.
PubMed 20227768Boyd 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 22578819Deighton J, Croudace T, Fonagy P, Brown J, Patalay P, Wolpert M. Measuring mental health and wellbeing outcomes for children and adolescents to inform practice and policy: a review of child self-report measures. Child Adolesc Psychiatry Ment Health. 2014 Apr 29;8:14. doi: 10.1186/1753-2000-8-14. eCollection 2014.
PubMed 24834111Ravens-Sieberer U, Erhart M, Rajmil L, Herdman M, Auquier P, Bruil J, Power M, Duer W, Abel T, Czemy L, Mazur J, Czimbalmos A, Tountas Y, Hagquist C, Kilroe J; European KIDSCREEN Group. Reliability, construct and criterion validity of the KIDSCREEN-10 score: a short measure for children and adolescents' well-being and health-related quality of life. Qual Life Res. 2010 Dec;19(10):1487-500. doi: 10.1007/s11136-010-9706-5. Epub 2010 Jul 30.
PubMed 20668950Rogers 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 9255837Rusch 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, 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 19269140Rusch 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 21632739Rusch N, Holzer A, Hermann C, Schramm E, Jacob GA, Bohus M, Lieb K, Corrigan PW. Self-stigma in women with borderline personality disorder and women with social phobia. J Nerv Ment Dis. 2006 Oct;194(10):766-73. doi: 10.1097/01.nmd.0000239898.48701.dc.
PubMed 17041289Wilson, CJ, Deane, FP, Ciarrochi, J, Rickwood, D. Measuring help-seeking intentions: Properties of General Help-Seeking Questionnaire. Canadian Journal of Counselling, 39(1), 15-28, 2005.
Yip PS, Cheung YB. Quick assessment of hopelessness: a cross-sectional study. Health Qual Life Outcomes. 2006 Mar 1;4:13. doi: 10.1186/1477-7525-4-13.
PubMed 16509984Keller, F, Konopka, L, Fegert, JM, Naumann, A . Prozessaspekte der Zufriedenheit von Jugendlichen in stationär-psychiatrischer Behandlung [Patient satisfaction of adolescents during in-patient psychiatric treatment: a process-oriented approach]. Nervenheilkunde 22: 40-46, 2003.
Goodman R. Psychometric properties of the strengths and difficulties questionnaire. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1337-45. doi: 10.1097/00004583-200111000-00015.
PubMed 11699809
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. 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 Adolescents With Mental Illness
- ClinicalTrials.gov ID
- NCT02751229
- Acronym / sponsor ID
- HOP-Adolescents
- Keywords
- Mental illness, adolescents, intervention, stigma, disclosure, secrecy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Collaborators
- Child and Adolescent Psychiatry Weissenau, Centre for Psychiatry in South-Württemberg, Germany, Josefinum, Child and Adolescent Psychiatry and Psychotherapy, Augsburg, Germany, Illinois Institute of Technology
- Study start
- May 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 26 Apr 2016 (estimated)
- 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 efficacy of the group-based intervention 'Honest Open Proud' among adolescents with mental illness.
Detailed description
Both due to fear of public stigma and due to self-stigma or shame, people with mental illness may decide to keep their condition a secret or even to withdraw from other people altogether in order to minimise the risk of being labelled. Secrecy can help on the short term to protect individuals from public stigma, but often it has negative long-term consequences such as social isolation, distress and unemployment. 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 evaluate whether a group program run both by people with mental illness (peers) and professionals helps to reduce self-stigma and makes it easier for adolescents to handle the necessary choices related to secrecy versus disclosure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Honest Open Proud | Experimental | Behavioral: Honest Open Proud (HOP)The group program is about disclosure ('coming out') versus secrecy of one's mental illness. The groups are facilitated by peers (young adults with mental illness) and mental health professionals. Each group runs for three weeks, one meeting per week, and two hours per meeting. Fidelity to manual: rated by PhD student in each session as proportion of key topics covered |
| Control Group | No intervention | –treatment as usual (TAU) |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- At least one self-reported current axis I or axis II disorder according to DSM-5 (American Psychiatric Association, 2013), which is not restricted to only substance-related disorder(s)
- Age 13 to 18
- Ability to provide written informed consent
- Fluid 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)five lessons in three modules, two for each two-hour session 1. Considering pros and cons of disclosing: * hurtful and helpful attitudes about mental illness * identify beliefs participants hold about themselves * explore five-step process to challenge their personally hurtful beliefs * weigh pros and cons of coming out in order to facilitate a decision on whether to disclose 2. Different ways to disclose: * different levels of (non-) disclosure and how to weigh the cons and pros * disclosure via social media versus disclosing face to face * how to find people that are better to disclose to than others and how to 'test them out' * participants will discuss how others might respond to their disclosure and how that will affect them 3. Telling your story: * how to tell one's story in a personally meaningful way, how to identify peers who might help with the coming out process, to review how telling one's story felt | Behavioural | Honest Open Proud |
Primary outcome
Stigma Stress Scale, 8 items (Rüsch, Corrigan, Wassel et al., 2009; Rüsch, Corrigan, Powell et al., 2009)
Time frame: 3 weeks (T1)
Health-Related Quality of Life Questionnaire KIDSCREEN-10 Index, 10 items (Deighton et al., 2014; Ravens-Sieberer et al., 2010)
Time frame: 6 weeks (T2)
11 secondary outcomes
Satisfaction with intervention questionnaire (according to Keller, Konopka, Fegert, & Naumann, 2003; own development)
Time frame: 3 weeks
Empowerment Scale, Subscales 'self-esteem' and 'control over the future', 13 items (Rogers, Chamberlin, Ellison, & Crean, 1997)
Time frame: baseline, 3 and 6 weeks
Attitudes to disclosure, 2 items (Rüsch, Evans-Lacko, Henderson, Flach, & Thornicroft, 2011)
Time frame: baseline, 3 and 6 weeks
Disclosure Distress, 1 item ("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)
Time frame: baseline, 3 and 6 weeks
Shame about having a mental illness, 1 item ("Do you feel ashamed about having a mental illness?"; from 1, not at all, to 7, very much) (Rüsch et al., 2014b)
Time frame: baseline, 3 and 6 weeks
General Help-Seeking Questionnaire, 1 item (Wilson et al., 2005)
Time frame: baseline, 3 and 6 weeks
Beck Hopelessness Scale (BHS), 4-item short version (Yip, Paul S F & Cheung, 2006)
Time frame: baseline, 3 and 6 weeks
Self-Stigma of Mental Illness Scale (SSMIS), Subscale 'self-concurrence', 5 items (Corrigan et al., 2012; Rüsch et al., 2006)
Time frame: baseline, 3 and 6 weeks
Self-Identified Stage of Recovery (SISR), 5 items (Andresen, Caputi, & Oades, 2010)
Time frame: baseline, 3 and 6 weeks
Internalised Stigma of Mental Illness Inventory (ISMI), 10-item short version (Boyd, Otilingam, & Deforge, 2014)
Time frame: baseline, 3 and 6 weeks
Social withdrawal and secrecy, 12 item-short version (Link et al., 2009)
Time frame: baseline, 3 and 6 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 9 May 2017.
- Background: PubMed 20227768Andresen R, Caputi P, Oades LG. Do clinical outcome measures assess consumer-defined recovery? Psychiatry Res. 2010 May 30;177(3):309-17. doi: 10.1016/j.psychres.2010.02.013. Epub 2010 Mar 15.
- 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 24834111Deighton J, Croudace T, Fonagy P, Brown J, Patalay P, Wolpert M. Measuring mental health and wellbeing outcomes for children and adolescents to inform practice and policy: a review of child self-report measures. Child Adolesc Psychiatry Ment Health. 2014 Apr 29;8:14. doi: 10.1186/1753-2000-8-14. eCollection 2014.
- Background: PubMed 20668950Ravens-Sieberer U, Erhart M, Rajmil L, Herdman M, Auquier P, Bruil J, Power M, Duer W, Abel T, Czemy L, Mazur J, Czimbalmos A, Tountas Y, Hagquist C, Kilroe J; European KIDSCREEN Group. Reliability, construct and criterion validity of the KIDSCREEN-10 score: a short measure for children and adolescents' well-being and health-related quality of life. Qual Life Res. 2010 Dec;19(10):1487-500. doi: 10.1007/s11136-010-9706-5. Epub 2010 Jul 30.
- 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 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 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.
- 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 17041289Rusch N, Holzer A, Hermann C, Schramm E, Jacob GA, Bohus M, Lieb K, Corrigan PW. Self-stigma in women with borderline personality disorder and women with social phobia. J Nerv Ment Dis. 2006 Oct;194(10):766-73. doi: 10.1097/01.nmd.0000239898.48701.dc.
- BackgroundWilson, CJ, Deane, FP, Ciarrochi, J, Rickwood, D. Measuring help-seeking intentions: Properties of General Help-Seeking Questionnaire. Canadian Journal of Counselling, 39(1), 15-28, 2005.
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, Professor principal investigator
Department of Psychiatry II, Section Public Mental Health, Ulm University, Bezirkskrankenhaus Günzburg, Germany
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Honest Open Proud (HOP) in people with Secrecy Versus Disclosure Among Adolescents With Mental Illness, run by University of Ulm at 5 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 5 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 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (Rüsch, Corrigan, Wassel et al., 2009; Rüsch, Corrigan, Powell et al., 2009) (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 NCT02751229, which also lists 18 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 9 May 2017.