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NCT Number: NCT06384755

Honest Open Proud for Psychotic and Bipolar Disorder in Norway

The purpose of this pilot study is to evaluate the feasibility, acceptability and efficacy of a Norwegian adaptation of the group-based intervention 'Honest Open Proud' among adults with psychotic and bipolar disorders in an outpatient setting.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nydalen DPS, Division of Mental Health and Addiction, Oslo University Hospital, Oslo, Norway

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About this study

Because people with mental illness experience both public and personal stigma, which is related to lower levels of recovery and wellbeing, it is common to struggle with decisions regarding potential disclosure of mental health difficulties or diagnoses. There are pros and cons with both disclosure and secrecy. Disclosure can lead to social support, followed by improved mental health and reduced public stigma, but also stigmatization and social exclusion. Secrecy can prevent stigmatization but may also lead to social isolation and thus poorer mental health and increased public stigma. Therefore, people with mental illness need help to make strategic decisions about whether, and if so, to whom, when and how they wish to disclose their mental health problems. As contact with other people with mental health difficulties is crucial to anti-stigma interventions, people with mental illness could benefit from meeting peers, especially as role models. This suggests that peer facilitators could be an important feature in a program aiming to help people with mental illness handle stigma and challenges related to disclosure. The Honest Open Proud (HOP) program was developed for this purpose. Because people with psychotic and bipolar disorders experience particularly high levels of both public and personal stigma, which negatively impacts their recovery rates, they may be especially in need of the HOP program.

The investigators aim to evaluate whether a Norwegian adaptation of the HOP group program, which is facilitated by peers, is feasible and acceptable for people with psychotic and bipolar disorders in an outpatient setting. Moreover, whether it helps them handle stigma and disclosure related decisions.

The investigators propose a pilot randomized controlled trial, comparing an intervention group receiving a 6-week Norwegian adaptation of the HOP program to a waiting list control group. Both groups receive treatment as usual. The main research question is whether this intervention is feasible and acceptable. However, efficacy measures tapping change in stigma and disclosure distress, as well as recovery and wellbeing, from before to after the intervention, were included. The aim is to find what effect sizes can be expected in future larger studies in Norway, rather than to find significant differences in effect sizes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed current psychotic (F 20) or bipolar disorder (F 30) according to International Classification of Diseases 10th Revision (ICD-10)
  • Age 18 to 65
  • Ability to provide written informed consent.
  • Fluent in Norwegian (needed for self-report measures)
  • Experience difficulties with stigma and disclosure regarding mental illness.

Exclusion criteria

  • Intellectual disability
  • Organic disorders

Treatment and study plan

Honest Open Proud program

Behavioral

The HOP program involves peer facilitated sessions, in which different stigma and disclosure related topics are introduced to the group, relevant tasks are completed individually, followed by group or two-and-two discussions related to the following topics: week 1 = pros and cons with disclosure, week 2 = different ways of disclosing, week 3 = formulating individual decisions of disclosure, week 6 = evaluating disclosure or non-disclosure in practice.

Other names: Coming Out Proud (COP)

Primary outcomes

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

    Time frame: Change from T0 to T1 and T2 (assessed at T0 = week 0; T1 =week 3; T2 = week 6)

    8 items, from 1 (strongly disagree) to 7 (strongly agree)

Secondary outcomes

  1. Disclosure Distress (Rüsch et al., 2014a)

    Time frame: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)

    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)

  2. Warwick and Edinburgh Wellbeing Scale (WEMWBS) (Tennant et al 2007)

    Time frame: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)

    14-items, from 1 (not at all) to 5 (all the time)

  3. Satisfaction with life (Lehman, 1988)

    Time frame: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)

    1 item from Lehmans Quality of Life Scale, from 1 (very dissatisfied) to 7 (very satisfied)

  4. The Questionnaire about the Process of Recovery - 15 (QPR-15) (Niel et al 2007)

    Time frame: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)

    15 items short version, from 0 (strongly disagree) to 4 (strongly agree)

  5. Internalised Stigma of Mental Illness Inventory (ISMI-10) (Boyd, Otilingam, & Deforge, 2014)

    Time frame: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)

    10-item short version, from 1 (strongly disagree ) to 4 (strongly agree )

  6. Patient Health Questionnaire-4 (PHQ-9) (Kroenke et al 2009)

    Time frame: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)

    9 items, 0 (not at all) to 3 (nearly every day)

  7. Generalized Anxiety disorder (GAD-7) (Spitzer et al, 2006)

    Time frame: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)

    7 items, from 0 (not at all) to 3 (nearly every day)

Other outcomes

  1. Disclosure

    Time frame: Assessed at T1 and T2 (T1= week 3 and T2 = week 6)

    "Have you disclosed your mental illness the last three (or six) weeks?", YES/NO "How satisfied are you with that?", from 1 (very dissatisfied) to 7 (very satisfied)

  2. Feasibility of HOP program

    Time frame: Tracked during trial and evaluated after completion (T2 = week 6)

    Recruitment rates (numbers of participants in number of weeks) and drop-out rates.

  3. Acceptability of HOP program participants

    Time frame: Assessed after T2 = week 6

    Semi-structured focus-group interview about acceptability with HOP program participants

  4. Acceptability of HOP peer facilitators

    Time frame: Assessed after T2 = week 6

    Semi-structured focus-group interview about acceptability with HOP peer facilitators

Study contacts

Contact information is provided by the study sponsor or research team.

Carmen Simonsen, PhD

CONTACT

[email protected]

0047 90988741

Sindre Hembre Kruse, BSc

CONTACT

[email protected]

0047 46440055

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • University of Oslo

Registry information

Official study title

Evaluation of a Norwegian Adaptation of the Honest Open Proud Program for Adults With Psychotic and Bipolar Disorders in an Outpatient Setting

Acronym: HOP-NOR

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Apr 25, 2024
Registry last updated
May 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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