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| ID | Type | Description | Link |
|---|---|---|---|
| 2022_HE2_409659 | Other Grant/Funding Number | The Dam Foundation | |
| 645788 | Other Identifier | Regional Ethics Committee (REK), South-East Norway |
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| Name | Class |
|---|---|
| University of Oslo | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carmen Simonsen, PhD | Contact | 0047 90988741 | carmen.simonsen@psykologi.uio.no | |
| Sindre Hembre Kruse, BSc | Contact | 0047 46440055 | sikrus@ous-hf.no |
| Name | Affiliation | Role |
|---|---|---|
| Carmen Simonsen, PhD | Department of Psychology, University of Oslo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nydalen DPS, Division of Mental Health and Addiction, Oslo University Hospital | Recruiting | Oslo | 0351 | Norway |
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| Label | URL |
|---|---|
| Description of the project in Norwegian | View source |
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The study protocol can be shared, but not the the actual data.
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D001714 | Bipolar Disorder |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
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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) |
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 |
| Søndre Oslo DPS, Division of Mental Health and Addiction, Oslo University Hospital | Not yet recruiting | Oslo | 1281 | Norway |
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