跳至主要内容
临床试验/NCT06384755
NCT06384755招募中不适用

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

Oslo University Hospital4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
4
主要终点
Stigma Stress Scale (Rüsch, Corrigan, Wassel et al., 2009; Rüsch, Corrigan, Powell et al., 2009)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Intellectual disability
  • Organic disorders

结局指标

主要结局

Stigma Stress Scale (Rüsch, Corrigan, Wassel et al., 2009; Rüsch, Corrigan, Powell et al., 2009)

时间窗: Change from T0 to T1 and T2 (assessed at T0 = week 0; T1 =week 3; T2 = week 6)

8 items, from 1 (strongly disagree) to 7 (strongly agree)

次要结局

  • 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))
  • Generalized Anxiety disorder (GAD-7) (Spitzer et al, 2006)(Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6))
  • 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))
  • Patient Health Questionnaire-4 (PHQ-9) (Kroenke et al 2009)(Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6))

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carmen Simonsen

Associate Professor

Oslo University Hospital

研究点 (4)

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