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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02751229
Other study ID # HOP-Adolescents
Secondary ID
Status Completed
Phase Phase 2
First received March 24, 2016
Last updated May 8, 2017
Start date May 2016
Est. completion date May 2017

Study information

Verified date March 2017
Source University of Ulm
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date May 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group 13 Years to 18 Years
Eligibility Inclusion Criteria:

- 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)

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 Design


Related Conditions & MeSH terms

  • Mental Disorders
  • Secrecy Versus Disclosure Among Adolescents With Mental Illness

Intervention

Behavioral:
Honest Open Proud (HOP)
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

Locations

Country Name City State
Germany Josefinum, Child and Adolescent Psychiatry and Psychotherapy Augsburg
Germany Child and Adolescent Psychiatry and Psychotherapy, University of Ulm Ulm
Germany Department of Psychiatry II, Section Public Mental Health, Ulm University, Bezirkskrankenhaus Günzburg Ulm
Germany Child and Adolescent Psychiatry Weissenau, Centre for Psychiatry in South-Württemberg Weissenau
United States Illinois Institute of Technology Chicago Illinois

Sponsors (5)

Lead Sponsor Collaborator
University of Ulm Child and Adolescent Psychiatry and Psychotherapy, University of Ulm, Germany, Child and Adolescent Psychiatry Weissenau, Centre for Psychiatry in South-Württemberg, Germany, Illinois Institute of Technology, Chicago, USA, Josefinum, Child and Adolescent Psychiatry and Psychotherapy, Augsburg, Germany

Countries where clinical trial is conducted

United States,  Germany, 

References & Publications (17)

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. — View Citation

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, Rüsch 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

Deighton 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. Review. — View Citation

Goodman R. Psychometric properties of the strengths and difficulties questionnaire. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1337-45. — View Citation

Keller, 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.

Meyer, TD, & Hautzinger, M. Allgemeine Depressions-Skala (ADS) [Center for Epidemiological Studies - Depression Scale (CES-D) - Norms for adolescents and extension for the assessment of manic symptoms]. Diagnostica, 47(4): 208-215, 2001.

Ravens-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. — 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. — View Citation

Rüsch N, Abbruzzese E, Hagedorn E, Hartenhauer D, Kaufmann I, Curschellas J, Ventling S, Zuaboni G, Bridler R, Olschewski M, Kawohl W, Rössler 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;204:391-7. doi: 10.1192/bjp.bp.113.135772. Epub 2014 Jan 16. — View Citation

Rüsch N, Corrigan PW, Heekeren K, Theodoridou A, Dvorsky D, Metzler S, Müller M, Walitza S, Rössler 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

Rüsch 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

Rüsch 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

Rüsch 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

Rüsch N, Hölzer 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. — View Citation

Wilson, 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. — View Citation

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Center for Epidemiologic Studies Depression Scale (CES-D), 15 items (Meyer & Hautzinger, 2001) baseline, 3 and 6 weeks
Other Strengths and Difficulties Questionnaire (SDQ), Subscale 'peer relationship problems', 5 items (Goodman, 2001) baseline, 3 and 6 weeks
Primary Stigma Stress Scale, 8 items (Rüsch, Corrigan, Wassel et al., 2009; Rüsch, Corrigan, Powell et al., 2009) 3 weeks (T1)
Primary Health-Related Quality of Life Questionnaire KIDSCREEN-10 Index, 10 items (Deighton et al., 2014; Ravens-Sieberer et al., 2010) 6 weeks (T2)
Secondary Satisfaction with intervention questionnaire (according to Keller, Konopka, Fegert, & Naumann, 2003; own development) 3 weeks
Secondary Empowerment Scale, Subscales 'self-esteem' and 'control over the future', 13 items (Rogers, Chamberlin, Ellison, & Crean, 1997) baseline, 3 and 6 weeks
Secondary 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 RĂ¼sch et al 2011 reference for further details) with seven-point Likert scale baseline, 3 and 6 weeks
Secondary 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) baseline, 3 and 6 weeks
Secondary 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) baseline, 3 and 6 weeks
Secondary General Help-Seeking Questionnaire, 1 item (Wilson et al., 2005) baseline, 3 and 6 weeks
Secondary Beck Hopelessness Scale (BHS), 4-item short version (Yip, Paul S F & Cheung, 2006) baseline, 3 and 6 weeks
Secondary Self-Stigma of Mental Illness Scale (SSMIS), Subscale 'self-concurrence', 5 items (Corrigan et al., 2012; Rüsch et al., 2006) baseline, 3 and 6 weeks
Secondary 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 baseline, 3 and 6 weeks
Secondary Internalised Stigma of Mental Illness Inventory (ISMI), 10-item short version (Boyd, Otilingam, & Deforge, 2014) baseline, 3 and 6 weeks
Secondary Social withdrawal and secrecy, 12 item-short version (Link et al., 2009) baseline, 3 and 6 weeks