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Идёт набор NCT06384755

Honest Open Proud for Psychotic and Bipolar Disorder in Norway

Без фазы С лечением Psychotic Disorders Bipolar Disorder Disclosure

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Honest Open Proud program.
Кому может быть актуально
Состояния в реестре: Psychotic Disorders, Bipolar Disorder, Disclosure. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Норвегия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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.

Первичные конечные точки

  • Stigma Stress Scale (Rüsch, Corrigan, Wassel et al., 2009; Rüsch, Corrigan, Powell et al., 2009) [Срок оценки: Change from T0 to T1 and T2 (assessed at T0 = week 0; T1 =week 3; T2 = week 6)]
Вторичные конечные точки (7)
  • Disclosure Distress (Rüsch et al., 2014a) [Срок оценки: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)]
  • Warwick and Edinburgh Wellbeing Scale (WEMWBS) (Tennant et al 2007) [Срок оценки: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)]
  • Satisfaction with life (Lehman, 1988) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)]
  • Patient Health Questionnaire-4 (PHQ-9) (Kroenke et al 2009) [Срок оценки: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)]
  • Generalized Anxiety disorder (GAD-7) (Spitzer et al, 2006) [Срок оценки: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • Intellectual disability
  • Organic disorders

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Норвегия · 2 центра
  • Nydalen DPS, Division of Mental Health and Addiction, Oslo University Hospital — Oslo
  • Søndre Oslo DPS, Division of Mental Health and Addiction, Oslo University Hospital — Oslo

Идентификаторы

NCT: NCT06384755 · 645788 · 2022_HE2_409659 · 645788

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗