Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384755
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-22
Brief Title:
Honest Open Proud for Psychotic and Bipolar Disorder in Norway
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Evaluation of a Norwegian Adaptation of the Honest Open Proud Program for Adults With Psychotic and Bipolar Disorders in an Outpatient Setting
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOP-NOR
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 645788 | OTHER | Regional Ethics Committee REK South-East Norway | None |
| 2022_HE2_409659 | OTHER_GRANT | None | None |