Honest Open Proud for Psychotic and Bipolar Disorder in Norway (HOP-NOR)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Psychotic Disorders; Bipolar Disorder; Disclosure
• Intervention / Treatment: Behavioral: Honest Open Proud program

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carmen Simonsen, PhD; Phone Number: 0047 90988741; Email: carmen.simonsen@psykologi.uio.no
• Study Contact Backup: Name: Sindre Hembre Kruse, BSc; Phone Number: 0047 46440055; Email: sikrus@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway, 0351
    • Recruiting
    • Nydalen DPS, Division of Mental Health and Addiction, Oslo University Hospital
    • Contact: Mari Husa, MD; Phone Number: 0047 95837846; Email: mahusa@ous-hf.no
    • Contact: Magnus Engen, PhD; Phone Number: 0047 41004660; Email: UXENMF@ous.hf.no
  • Oslo, Norway, 1281
    • Not yet recruiting
    • Søndre Oslo DPS, Division of Mental Health and Addiction, Oslo University Hospital
    • Contact: Marit Haram, PhD; Phone Number: 0047 21077000; Email: mharam@ous.hf.no
    • Contact: Hilde Aasli Daler, MSc; Phone Number: 0047 23023100; Email: uxruhi@ous-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Coming Out Proud (COP)
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
Acceptability of HOP program participants	Semi-structured focus-group interview about acceptability with HOP program participants	Assessed after T2 = week 6
Acceptability of HOP peer facilitators	Semi-structured focus-group interview about acceptability with HOP peer facilitators	Assessed after T2 = week 6

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of Oslo
• Investigators: Principal Investigator: Carmen Simonsen, PhD, Department of Psychology, University of Oslo

Publications and helpful links

Helpful Links

• Description of the project in Norwegian

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Estimated): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Honest Open Proud program; Psychotic and Bipolar disorders
• Additional Relevant MeSH Terms: Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Psychotic Disorders; Mental Disorders; Bipolar Disorder
• Other Study ID Numbers: 645788 (Other Identifier: Regional Ethics Committee (REK), South-East Norway); 2022_HE2_409659 (Other Grant/Funding Number: The Dam Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study protocol can be shared, but not the the actual data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No