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Honest Open Proud for Adolescents With Mental Illness

Primary Purpose

Secrecy Versus Disclosure Among Adolescents With Mental Illness

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Honest Open Proud (HOP)

About this trial

This is an interventional treatment trial for Secrecy Versus Disclosure Among Adolescents With Mental Illness focused on measuring Mental illness, adolescents, intervention, stigma, disclosure, secrecy

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Honest Open Proud

Control Group

Arm Description

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

treatment as usual (TAU)

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

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

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)

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)

General Help-Seeking Questionnaire, 1 item (Wilson et al., 2005)

Beck Hopelessness Scale (BHS), 4-item short version (Yip, Paul S F & Cheung, 2006)

Self-Stigma of Mental Illness Scale (SSMIS), Subscale 'self-concurrence', 5 items (Corrigan et al., 2012; Rüsch et al., 2006)

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

Internalised Stigma of Mental Illness Inventory (ISMI), 10-item short version (Boyd, Otilingam, & Deforge, 2014)

Social withdrawal and secrecy, 12 item-short version (Link et al., 2009)

Full Information

NCT ID

NCT02751229

First Posted

March 24, 2016

Last Updated

May 8, 2017

Sponsor

University of Ulm

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, Chicago, USA

1. Study Identification

Unique Protocol Identification Number

NCT02751229

Brief Title

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

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

May 2016 (undefined)

Primary Completion Date

May 2017 (Actual)

Study Completion Date

May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Ulm

Collaborators

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Secrecy Versus Disclosure Among Adolescents With Mental Illness

Keywords

Mental illness, adolescents, intervention, stigma, disclosure, secrecy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Honest Open Proud

Arm Type

Experimental

Arm Description

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

treatment as usual (TAU)

Intervention Type

Behavioral

Intervention Name(s)

Honest Open Proud (HOP)

Other Intervention Name(s)

Coming Out Proud (COP)

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

3 weeks (T1)

Title

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)

Secondary Outcome Measure Information:

Title

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

Time Frame

3 weeks

Title

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

Time Frame

baseline, 3 and 6 weeks

Title

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

Description

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

Time Frame

baseline, 3 and 6 weeks

Title

Time Frame

baseline, 3 and 6 weeks

Title

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

Title

General Help-Seeking Questionnaire, 1 item (Wilson et al., 2005)

Time Frame

baseline, 3 and 6 weeks

Title

Beck Hopelessness Scale (BHS), 4-item short version (Yip, Paul S F & Cheung, 2006)

Time Frame

baseline, 3 and 6 weeks

Title

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

Title

Self-Identified Stage of Recovery (SISR), 5 items (Andresen, Caputi, & Oades, 2010)

Description

Time Frame

baseline, 3 and 6 weeks

Title

Internalised Stigma of Mental Illness Inventory (ISMI), 10-item short version (Boyd, Otilingam, & Deforge, 2014)

Time Frame

baseline, 3 and 6 weeks

Title

Social withdrawal and secrecy, 12 item-short version (Link et al., 2009)

Time Frame

baseline, 3 and 6 weeks

Other Pre-specified Outcome Measures:

Title

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

Time Frame

baseline, 3 and 6 weeks

Title

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

Time Frame

baseline, 3 and 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicolas Rüsch, Professor

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Illinois Institute of Technology

City

Chicago

State/Province

Illinois

Country

United States

Facility Name

Josefinum, Child and Adolescent Psychiatry and Psychotherapy

City

Augsburg

Country

Germany

Facility Name

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

City

Ulm

ZIP/Postal Code

89073

Country

Germany

Facility Name

Child and Adolescent Psychiatry and Psychotherapy, University of Ulm

City

Ulm

Country

Germany

Facility Name

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

City

Weissenau

Country

Germany

12. IPD Sharing Statement

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Honest Open Proud for Adolescents With Mental Illness

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