Clinical trial NCT02751229: Honest Open Proud for Adolescents With Mental Illness
Official title: Adaptation and Evaluation of the Honest Open Proud Program for Adolescents With Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Secrecy Versus Disclosure Among Adolescents With Mental Illness
Keywords: Mental illness
adolescents
intervention
stigma
disclosure
secrecy
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: Child and Adolescent Psychiatry Weissenau, Centre for Psychiatry in South-Württemberg, Germany
name: Josefinum, Child and Adolescent Psychiatry and Psychotherapy, Augsburg, Germany
name: Illinois Institute of Technology, Chicago, USA
First posted: 2016-04-26
Enrollment: 100
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stigma Stress Scale, 8 items (Rüsch, Corrigan, Wassel et al., 2009; Rüsch, Corrigan, Powell et al., 2009)
timeFrame: 3 weeks (T1)
measure: Health-Related Quality of Life Questionnaire KIDSCREEN-10 Index, 10 items (Deighton et al., 2014; Ravens-Sieberer et al., 2010)
timeFrame: 6 weeks (T2)
Secondary outcomes:
measure: Satisfaction with intervention questionnaire (according to Keller, Konopka, Fegert, & Naumann, 2003; own development)
timeFrame: 3 weeks
measure: Empowerment Scale, Subscales 'self-esteem' and 'control over the future', 13 items (Rogers, Chamberlin, Ellison, & Crean, 1997)
timeFrame: baseline, 3 and 6 weeks
measure: Attitudes to disclosure, 2 items (Rüsch, Evans-Lacko, Henderson, Flach, & Thornicroft, 2011)
timeFrame: baseline, 3 and 6 weeks
measure: 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)
timeFrame: baseline, 3 and 6 weeks
measure: 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)
timeFrame: baseline, 3 and 6 weeks
measure: General Help-Seeking Questionnaire, 1 item (Wilson et al., 2005)
timeFrame: baseline, 3 and 6 weeks
measure: Beck Hopelessness Scale (BHS), 4-item short version (Yip, Paul S F & Cheung, 2006)
timeFrame: baseline, 3 and 6 weeks
measure: Self-Stigma of Mental Illness Scale (SSMIS), Subscale 'self-concurrence', 5 items (Corrigan et al., 2012; Rüsch et al., 2006)
timeFrame: baseline, 3 and 6 weeks
measure: Self-Identified Stage of Recovery (SISR), 5 items (Andresen, Caputi, & Oades, 2010)
timeFrame: baseline, 3 and 6 weeks
measure: Internalised Stigma of Mental Illness Inventory (ISMI), 10-item short version (Boyd, Otilingam, & Deforge, 2014)
timeFrame: baseline, 3 and 6 weeks
measure: Social withdrawal and secrecy, 12 item-short version (Link et al., 2009)
timeFrame: baseline, 3 and 6 weeks
Other outcomes:
measure: Center for Epidemiologic Studies Depression Scale (CES-D), 15 items (Meyer & Hautzinger, 2001)
timeFrame: baseline, 3 and 6 weeks
measure: Strengths and Difficulties Questionnaire (SDQ), Subscale 'peer relationship problems', 5 items (Goodman, 2001)
timeFrame: baseline, 3 and 6 weeks
Locations:
city: Chicago
country: United States
facility: Illinois Institute of Technology
state: Illinois
city: Augsburg
country: Germany
facility: Josefinum, Child and Adolescent Psychiatry and Psychotherapy
city: Ulm
country: Germany
facility: Department of Psychiatry II, Section Public Mental Health, Ulm University, Bezirkskrankenhaus Günzburg
city: Ulm
country: Germany
facility: Child and Adolescent Psychiatry and Psychotherapy, University of Ulm
city: Weissenau
country: Germany
facility: Child and Adolescent Psychiatry Weissenau, Centre for Psychiatry in South-Württemberg
Study officials:
affiliation: Department of Psychiatry II, Section Public Mental Health, Ulm University, Bezirkskrankenhaus Günzburg, Germany
name: Nicolas Rüsch, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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