Honest Open Proud for Psychotic and Bipolar Disorder in Norway

NCT ID: NCT06384755

Last Updated: 2024-05-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-20
• Study Completion Date: 2026-12-31

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.

Conditions

Psychotic Disorders; Bipolar Disorder; Disclosure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

Intervention group: receives the HOP program consisting of four 2-hour sessions divided between week 1, week 2, week 3 and week 6, in groups of 4-10 participants, using a Norwegian adaptation of HOP workbook. The intervention group also receives treatment as usual, consisting of weekly or monthly appointments with a mental health care professional at an outpatient unit in the public mental health care service. The appointments can involve medication management, psychoeducation, support therapy or psychotherapy.

Group Type: EXPERIMENTAL

Honest Open Proud program

Intervention Type: 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.

Waiting list control group

Waiting list control group: receives only treatment as usual, consisting of weekly or monthly appointments with a mental health care professional at an outpatient unit in the public mental health care service. The appointments can involve medication management, psychoeducation, support therapy or psychotherapy.

They are offered the HOP program after the trial.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Coming Out Proud (COP)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Carmen Simonsen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carmen Simonsen, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychology, University of Oslo

Locations

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

Oslo, , Norway

Site Status: RECRUITING

Søndre Oslo DPS, Division of Mental Health and Addiction, Oslo University Hospital

Oslo, , Norway

Site Status: NOT_YET_RECRUITING

Countries

Norway

Central Contacts

Carmen Simonsen, PhD

Role: CONTACT

carmen.simonsen@psykologi.uio.no

0047 90988741

Sindre Hembre Kruse, BSc

Role: CONTACT

sikrus@ous-hf.no

0047 46440055

Facility Contacts

Mari Husa, MD

Role: primary

mahusa@ous-hf.no

0047 95837846

Magnus Engen, PhD

Role: backup

UXENMF@ous.hf.no

0047 41004660

Hilde Aasli Daler, MSc

Role: primary

uxruhi@ous-hf.no

0047 23023100

Marit Haram, PhD

Role: backup

mharam@ous.hf.no

0047 21077000

Related Links

https://www.oslo-universitetssykehus.no/avdelinger/klinikk-psykisk-helse-og-avhengighet/forsknings-og-innovasjonsavdelingen-i-pha/regionalt-kompetansesenter-for-tidlig-intervensjon-ved-psykoser/apen-og-varsom-om-psykose-og-bipolar-lidelse-bruker-til-bruker

Description of the project in Norwegian

Other Identifiers

2022_HE2_409659

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

645788

Identifier Type: OTHER

Identifier Source: secondary_id

645788

Identifier Type: -

Identifier Source: org_study_id