Clinical trial NCT06384755: Honest Open Proud for Psychotic and Bipolar Disorder in Norway
Official title: Evaluation of a Norwegian Adaptation of the Honest Open Proud Program for Adults With Psychotic and Bipolar Disorders in an Outpatient Setting
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychotic Disorders
Bipolar Disorder
Disclosure
Keywords: Honest Open Proud program
Psychotic and Bipolar disorders
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2024-04-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Stigma Stress Scale (Rüsch, Corrigan, Wassel et al., 2009; Rüsch, Corrigan, Powell et al., 2009)
timeFrame: Change from T0 to T1 and T2 (assessed at T0 = week 0; T1 =week 3; T2 = week 6)
Secondary outcomes:
measure: Disclosure Distress (Rüsch et al., 2014a)
timeFrame: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)
measure: Warwick and Edinburgh Wellbeing Scale (WEMWBS) (Tennant et al 2007)
timeFrame: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)
measure: Satisfaction with life (Lehman, 1988)
timeFrame: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)
measure: The Questionnaire about the Process of Recovery - 15 (QPR-15) (Niel et al 2007)
timeFrame: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)
measure: Internalised Stigma of Mental Illness Inventory (ISMI-10) (Boyd, Otilingam, & Deforge, 2014)
timeFrame: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)
measure: Patient Health Questionnaire-4 (PHQ-9) (Kroenke et al 2009)
timeFrame: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)
measure: Generalized Anxiety disorder (GAD-7) (Spitzer et al, 2006)
timeFrame: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)
Other outcomes:
measure: Disclosure
timeFrame: Assessed at T1 and T2 (T1= week 3 and T2 = week 6)
measure: Feasibility of HOP program
timeFrame: Tracked during trial and evaluated after completion (T2 = week 6)
measure: Acceptability of HOP program participants
timeFrame: Assessed after T2 = week 6
measure: Acceptability of HOP peer facilitators
timeFrame: Assessed after T2 = week 6
Locations:
city: Oslo
country: Norway
facility: Nydalen DPS, Division of Mental Health and Addiction, Oslo University Hospital
city: Oslo
country: Norway
facility: Søndre Oslo DPS, Division of Mental Health and Addiction, Oslo University Hospital
Study officials:
affiliation: Department of Psychology, University of Oslo
name: Carmen Simonsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: