Honest Open Proud for Adolescents With Mental Illness

May 8, 2017 updated by: Nicolas Rüsch, University of Ulm

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Augsburg, Germany
        • Josefinum, Child and Adolescent Psychiatry and Psychotherapy
      • Ulm, Germany, 89073
        • Department of Psychiatry II, Section Public Mental Health, Ulm University, Bezirkskrankenhaus Günzburg
      • Ulm, Germany
        • Child and Adolescent Psychiatry and Psychotherapy, University of Ulm
      • Weissenau, Germany
        • Child and Adolescent Psychiatry Weissenau, Centre for Psychiatry in South-Württemberg
  • United States
    • Illinois
      • Chicago, Illinois, United States
        • Illinois Institute of Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Honest Open Proud

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)

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
Other Names:
  • Coming Out Proud (COP)
No Intervention: Control Group
treatment as usual (TAU)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stigma Stress Scale, 8 items (Rüsch, Corrigan, Wassel et al., 2009; Rüsch, Corrigan, Powell et al., 2009)
Time Frame: 3 weeks (T1)
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)
6 weeks (T2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with intervention questionnaire (according to Keller, Konopka, Fegert, & Naumann, 2003; own development)
Time Frame: 3 weeks
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
baseline, 3 and 6 weeks
Attitudes to disclosure, 2 items (Rüsch, Evans-Lacko, Henderson, Flach, & Thornicroft, 2011)
Time Frame: baseline, 3 and 6 weeks
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
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
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
baseline, 3 and 6 weeks
General Help-Seeking Questionnaire, 1 item (Wilson et al., 2005)
Time Frame: baseline, 3 and 6 weeks
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
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
baseline, 3 and 6 weeks
Self-Identified Stage of Recovery (SISR), 5 items (Andresen, Caputi, & Oades, 2010)
Time Frame: baseline, 3 and 6 weeks
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
Internalised Stigma of Mental Illness Inventory (ISMI), 10-item short version (Boyd, Otilingam, & Deforge, 2014)
Time Frame: baseline, 3 and 6 weeks
baseline, 3 and 6 weeks
Social withdrawal and secrecy, 12 item-short version (Link et al., 2009)
Time Frame: baseline, 3 and 6 weeks
baseline, 3 and 6 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Center for Epidemiologic Studies Depression Scale (CES-D), 15 items (Meyer & Hautzinger, 2001)
Time Frame: baseline, 3 and 6 weeks
baseline, 3 and 6 weeks
Strengths and Difficulties Questionnaire (SDQ), Subscale 'peer relationship problems', 5 items (Goodman, 2001)
Time Frame: baseline, 3 and 6 weeks
baseline, 3 and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Collaborators

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

Investigators

  • Principal Investigator: Nicolas Rüsch, Professor, Department of Psychiatry II, Section Public Mental Health, Ulm University, Bezirkskrankenhaus Günzburg, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

March 24, 2016

First Submitted That Met QC Criteria

April 21, 2016

First Posted (Estimate)

April 26, 2016

Study Record Updates

Last Update Posted (Actual)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 8, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOP-Adolescents

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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