Honest Open Proud for Psychotic and Bipolar Disorder in Norway

NCT06384755 | Recruiting

• 2 other identifiers: 6457882022_HE2_409659
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Psychotic Disorders; Bipolar Disorder; Disclosure

Keywords

Honest Open Proud program; Psychotic and Bipolar disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

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

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

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

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

• Satisfaction with life (Lehman, 1988)

  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)

  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)

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

Other Outcomes (4)

• Disclosure

  Assessed at T1 and T2 (T1= week 3 and T2 = week 6)

• Feasibility of HOP program

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

• Acceptability of HOP program participants

  Assessed after T2 = week 6

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Waiting list control group

NO INTERVENTION

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.

Interventions

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.

Also known as: Coming Out Proud (COP)

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Intellectual disability
• Organic disorders

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator

Study Sites (2)

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

Oslo, 0351, Norway

RECRUITING

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

Oslo, 1281, Norway

NOT YET RECRUITING

Related Links

• Description of the project in Norwegian

MeSH Terms

Conditions

Psychotic Disorders; Bipolar Disorder; Mental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Mood Disorders

Study Officials

• Carmen Simonsen, PhD

  Department of Psychology, University of Oslo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carmen Simonsen, PhD

CONTACT

0047 90988741; carmen.simonsen@psykologi.uio.no

Sindre Hembre Kruse, BSc

CONTACT

0047 46440055; sikrus@ous-hf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: April 20, 2024
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)