NCT02751229

Brief Summary

The purpose of the study is to evaluate the efficacy of the group-based intervention 'Honest Open Proud' among adolescents with mental illness.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2016

Shorter than P25 for phase_2

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 9, 2017

Status Verified

March 1, 2017

Enrollment Period

1 year

First QC Date

March 24, 2016

Last Update Submit

May 8, 2017

Conditions

Keywords

Mental illnessadolescentsinterventionstigmadisclosuresecrecy

Outcome Measures

Primary Outcomes (2)

  • Stigma Stress Scale, 8 items (Rüsch, Corrigan, Wassel et al., 2009; Rüsch, Corrigan, Powell et al., 2009)

    3 weeks (T1)

  • Health-Related Quality of Life Questionnaire KIDSCREEN-10 Index, 10 items (Deighton et al., 2014; Ravens-Sieberer et al., 2010)

    6 weeks (T2)

Secondary Outcomes (11)

  • Satisfaction with intervention questionnaire (according to Keller, Konopka, Fegert, & Naumann, 2003; own development)

    3 weeks

  • Empowerment Scale, Subscales 'self-esteem' and 'control over the future', 13 items (Rogers, Chamberlin, Ellison, & Crean, 1997)

    baseline, 3 and 6 weeks

  • Attitudes to disclosure, 2 items (Rüsch, Evans-Lacko, Henderson, Flach, & Thornicroft, 2011)

    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)

    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)

    baseline, 3 and 6 weeks

  • +6 more secondary outcomes

Other Outcomes (2)

  • Center for Epidemiologic Studies Depression Scale (CES-D), 15 items (Meyer & Hautzinger, 2001)

    baseline, 3 and 6 weeks

  • Strengths and Difficulties Questionnaire (SDQ), Subscale 'peer relationship problems', 5 items (Goodman, 2001)

    baseline, 3 and 6 weeks

Study Arms (2)

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

Behavioral: Honest Open Proud (HOP)

Control Group

NO INTERVENTION

treatment as usual (TAU)

Interventions

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

Also known as: Coming Out Proud (COP)
Honest Open Proud

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Illinois Institute of Technology

Chicago, Illinois, United States

Location

Josefinum, Child and Adolescent Psychiatry and Psychotherapy

Augsburg, Germany

Location

Department of Psychiatry II, Section Public Mental Health, Ulm University, Bezirkskrankenhaus Günzburg

Ulm, 89073, Germany

Location

Child and Adolescent Psychiatry and Psychotherapy, University of Ulm

Ulm, Germany

Location

Child and Adolescent Psychiatry Weissenau, Centre for Psychiatry in South-Württemberg

Weißenau, Germany

Location

Related Publications (18)

  • 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.

    PMID: 20227768BACKGROUND
  • 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.

    PMID: 24660946BACKGROUND
  • 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.

    PMID: 22578819BACKGROUND
  • 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.

    PMID: 24834111BACKGROUND
  • 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.

    PMID: 20668950BACKGROUND
  • 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.

    PMID: 9255837BACKGROUND
  • 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.

    PMID: 24382666BACKGROUND
  • 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.

    PMID: 19237266BACKGROUND
  • 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.

    PMID: 19269140BACKGROUND
  • 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.

    PMID: 21632739BACKGROUND
  • Rusch 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.

    PMID: 17041289BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 16509984BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 11699809BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 24434073BACKGROUND
  • Mulfinger N, Muller S, Boge I, Sakar V, Corrigan PW, Evans-Lacko S, Nehf L, Djamali J, Samarelli A, Kempter M, Ruckes C, Libal G, Oexle N, Noterdaeme M, Rusch N. Honest, Open, Proud for adolescents with mental illness: pilot randomized controlled trial. J Child Psychol Psychiatry. 2018 Jun;59(6):684-691. doi: 10.1111/jcpp.12853. Epub 2017 Dec 5.

MeSH Terms

Conditions

Mental DisordersSocial Stigma

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Nicolas Rüsch, Professor

    Department of Psychiatry II, Section Public Mental Health, Ulm University, Bezirkskrankenhaus Günzburg, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 24, 2016

First Posted

April 26, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 9, 2017

Record last verified: 2017-03

Locations