Honest Open Proud for Psychotic and Bipolar Disorder in Norway

Bipolar Disorder Clinical Trial

— HOP-NOR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06384755
• Other study ID #: 645788
• Secondary ID: 2022_HE2_4096596
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Oslo University Hospital
• Contact: Carmen Simonsen, PhD
• Phone: 0047 90988741
• Email: carmen.simonsen[@]psykologi.uio.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Disclosure
• Mental Disorders
• Psychotic Disorders

Intervention

Behavioral:
• Honest Open Proud program
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.

Locations

Country	Name	City	State
Norway	Nydalen DPS, Division of Mental Health and Addiction, Oslo University Hospital	Oslo
Norway	Søndre Oslo DPS, Division of Mental Health and Addiction, Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Disclosure	"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)	Assessed at T1 and T2 (T1= week 3 and T2 = week 6)
Other	Feasibility of HOP program	Recruitment rates (numbers of participants in number of weeks) and drop-out rates.	Tracked during trial and evaluated after completion (T2 = week 6)
Other	Acceptability of HOP program participants	Semi-structured focus-group interview about acceptability with HOP program participants	Assessed after T2 = week 6
Other	Acceptability of HOP peer facilitators	Semi-structured focus-group interview about acceptability with HOP peer facilitators	Assessed after T2 = week 6
Primary	Stigma Stress Scale (Rüsch, Corrigan, Wassel et al., 2009; Rüsch, Corrigan, Powell et al., 2009)	8 items, from 1 (strongly disagree) to 7 (strongly agree)	Change from T0 to T1 and T2 (assessed at T0 = week 0; T1 =week 3; T2 = week 6)
Secondary	Disclosure Distress (Rüsch et al., 2014a)	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)	Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)
Secondary	Warwick and Edinburgh Wellbeing Scale (WEMWBS) (Tennant et al 2007)	14-items, from 1 (not at all) to 5 (all the time)	Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)
Secondary	Satisfaction with life (Lehman, 1988)	1 item from Lehmans Quality of Life Scale, from 1 (very dissatisfied) to 7 (very satisfied)	Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)
Secondary	The Questionnaire about the Process of Recovery - 15 (QPR-15) (Niel et al 2007)	15 items short version, from 0 (strongly disagree) to 4 (strongly agree)	Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)
Secondary	Internalised Stigma of Mental Illness Inventory (ISMI-10) (Boyd, Otilingam, & Deforge, 2014)	10-item short version, from 1 (strongly disagree ) to 4 (strongly agree )	Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)
Secondary	Patient Health Questionnaire-4 (PHQ-9) (Kroenke et al 2009)	9 items, 0 (not at all) to 3 (nearly every day)	Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)
Secondary	Generalized Anxiety disorder (GAD-7) (Spitzer et al, 2006)	7 items, from 0 (not at all) to 3 (nearly every day)	Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)

External Links

•   Description of the project in Norwegian