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临床试验/NCT07556575
NCT07556575尚未招募不适用

Mer Aktiv Rehabilitering - en Interventionsstudie Inom Vuxenpsykiatrin

Region Halland0 个研究点目标入组 60 人开始时间: 2026年4月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Level of daily occupations

研究概览

简要总结

The Mer aktiv rehabilitaion project aims to develop and evaluate a sustainable lifestyle intervention for individuals with mental ill health. By combining clinical experience, current evidence, and interprofessional collaboration between outpatient psychiatric services and community stakeholders, the project seeks to create conditions for a more active and balanced everyday life for individuals with mental ill health. The Mer Aktiv intervention focuses on breaking social isolation, promoting activity, and strengthening participants' empowerment through healthy lifestyle behaviours, group cohesion, and community-based activities. The aim of the intervention is to increase participation in everyday life and in society, as well as to support participants in remaining active after the intervention has ended. An increased level of activity, in which participants feel a sense of belonging within society, creates conditions for individuals to gradually move closer to the labour market over time. The project examines the feasibility and relevance of the intervention as a collaborative initiative between outpatient psychiatric care and community stakeholders, with the aim of refining the intervention and identifying potential barriers to implementation.

The aim is to develop and evaluate a multiprofessional lifestyle intervention for individuals receiving outpatient psychiatric care.

详细描述

For guidance, the framework for the evaluation of complex interventions will be used, along with the use of progression criteria to determine whether it is appropriate to move on to the next phase. To study feasibility, the group-based intervention will be evaluated in the form of a feasibility study, assessing aspects such as recruitment, adherence to the intervention, and data-collection. During Phase 1, the experiences of both staff and participants will be explored to refine the intervention based on their feedback.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Enrolled in adult outpatient psychiatric care
  • Not engaged in any form of organized occupation, such as employment, studies, or work-based rehabilitation
  • Physical exercise/structured physical activity outside the home less than once per week
  • Participation in organized leisure activities less than once per week
  • Able to walk independently without assistance
  • No need for an interpreter

排除标准

  • Inability to attend sessions twice per week (e.g., due to distance or lack of transportation)
  • Ongoing individual psychotherapy
  • Current or planned participation in another group-based intervention
  • Ongoing substance use disorder, acute suicidality, or active psychosis (assessed based on the individual's capacity to manage symptoms and ability to participate in a group setting)

研究组 & 干预措施

Multiprofessional lifestyle group-intervention

Experimental

An 11 week group intervention (20 group sessions in total), including individual asessement before and individual follow-up after intervention. Furthermore a booster goup session after 5-6 months.

干预措施: Mer aktiv rehabilitation - A group-based lifestyle intervention within psychiatric care (Behavioral)

结局指标

主要结局

Level of daily occupations

时间窗: Pre-post, 6 months, 1 year

Level of daily occupations will be collected using the occupational therapy assessment instrument Satisfaction with Daily Occupations (SDO-13) (13 questions conserning daily occupations distributed across the domains work/studies, leisure, home and maintenance, and self-care: response options Yes or No, Range 0-13)(13 indicates the highest level of activity). Data-collection with SDO-13 at Pre, Post and 6 months. Data-collection with a 5-item questionnaire "Occupational level over time" at 1 years follow up (developed by the research group with inspiration from SDO-13 and specified inclusion criteria)(response options Yes or No)(Change in daily occupations from recruitment until 1 year)(Change from No to Yes indicates an improvement) in (Q1-2) employment/studies, (Q3) structured rehabilitation (Q4) physical exercise, (Q5) leisure activiries.

Satisfaction with daily occupations

时间窗: Pre-Post, 6 months.

Satisfaction with Daily Occupations (SDO-13) will be collected using the occupational therapy assessment instrument Satisfaction with Daily Occupations (SDO-13) (13 questions conserning daily occupations distributed across the domains work/studies, leisure, home and maintenance, and self-care: response options Yes or No; satisfaction with daily occupations based on the same 13 questions: 7-point scale, 1 = worst imaginable satisfaction, 7 = best imaginable satisfaction.

Physical activity and sedentary behaviour

时间窗: Pre-Post, 6 months, 1 year.

Physical activity and sedentary behaviour (3-item Swedish National Board of Health and Welfare). To measure physical activity, the indicator questions developed by the Swedish National Board of Health and Welfare will be used (3 questions; number of minutes spent in vigorous physical activity and everyday physical activities, respectively, as well as an estimate of the time spent sitting). Increase in minutes in physical activities is better, decrease in time spent sitting is better. The three items are analysed seperatly.

次要结局

  • Occupational balance(Pre-Post, 6 months, 1 year.)
  • Anxiety(Pre-Post, 6 months, 1 year.)
  • Health / Depression(Pre-post, 6 months, 1 year.)
  • Sleep health(Pre-post, 6 months, 1 year.)
  • Recovery(Pre-post, 6 months, 1 year.)
  • Work ability(Pre-post, 6 months, 1 year.)

研究者

申办方类型
Other
责任方
Sponsor

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