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临床试验/NCT03963245
NCT03963245已完成不适用

Project Meaningful Activities and Recovery (MA&R)

Amager Hospital4 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2018年9月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
139
试验地点
4
主要终点
Profiles of occupational engagement in people with severe mental illness (POES-S).

研究概览

简要总结

Occupational therapy interventions are often part of the treatment and rehabilitation services offered to people with mental illnesses. Occupational therapy can be an important contribution when the purpose is to promote participation in everyday activities that are meaningful for the individual. (1-3) There is limited evidence to support whether occupational therapy interventions for people with mental illnesses have an effect. (2,3) Based on principles from Lifestyle Redesign®, which is an evidence-based occupational therapy intervention for older people, a comparative qualitative study with participant experiences from various psychosocial rehabilitation efforts, and a dialogue-based collaboration with experienced occupational therapists and peer staff from community mental health centers, we developed a new recovery oriented occupational therapy intervention to people with disabilities due to mental illness.

The intervention "Meaningful activities and recovery" (MA&R) - is an eight-month rehabilitation program. The aim of MA&R is to enable participation in activities that are meaningful to the individual.

Project Meaningful Activities and Recovery (MA&R) is a clinical trial where the purpose is to compare the effects of: 1) "Meaningful activities and Recovery" (MA&R) in addition to standard care and 2) standard care as it is now offered to people with psychiatric disabilities.

The design is a randomized clinical trial with self-reported assessments. Based on sample size calculation, 128 participants will be included in the trials. The primary endpoint is activity engagement, and the secondary effect goals are personal recovery, functioning and quality of life. Participants are followed up at the end of the intervention, after eight months.

详细描述

Participants Participants are people, diagnosed with mental illness and who uses services in either community mental health centres in Copenhagen, or live in supported accommodations, or receive psychiatric rehabilitation services in Copenhagen, Odense or Svendborg, three Danish cities.

Recruitment The initial contact with the participants is done by staff at the community mental health centres, supported housings or rehabilitation services in Copenhagen, Odense and Svendborg, talking with relevant candidates based on the research project's inclusion and exclusion criteria and informing them orally and in writing about the research project. This is supplemented, with the approval of the sites, by hanging posters in common rooms and possibly. presentation by researcher to the resident group / patients / citizen group at joint meeting to encourage self-referral. People who are interested in participating in the research project (hereinafter referred to as potential participants) contact the researcher or notify this to staff who communicate contact with researcher on behalf of citizens. An appointment is made for information interviews and pre-screening. Potential participants are invited to bring relatives or a contact person to the appointment. The oral information is given before the written one, and it is ensured that the information conversation takes place undisturbed. The participant information is provided in the form of a folder with adequate information about the experiment. The potential participant is informed that participation in the trial is voluntary and should not have any side effects, and that at any time they may exit the trial, without consequence for future support and the right to psychiatric treatment or rehabilitation services.

If the prospective participant, after being informed of the research project, is still interested in participating in the research project, the researcher conducts a functional level assessment at Mini-ICF-APP and asks the potential participant whether he or she is diagnosed with a mental illness. Based on this, it is decided whether the potential participant can be included.

Then, a consent form is handed out. Three-day reflection time (at least 24 hours) is offered. The written consent will be dated and numbered with the participant number. The participant will receive a copy while the original will be archived in a locked cabinet and scanned electronically and stored on a logged drive.

When written consent is given, the researcher obtains data by asking the participant, ie. self-reporting socio-demographic data and information on the mental illness. The researcher sends questionnaires to the participant, either electronically or as a letter, depending on what the participant prefers.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >18 years old
  • Has disability assessment assessed by researcher at Mini-ICF Rating for Limitations of Activities and Participation in Psychological Disorders (Mini-ICF-APP) (28)
  • Be diagnosed with a mental disorder and have been associated with the psychiatric treatment system, either by admission or outpatient contact.
  • Has given informed consent

排除标准

  • Diagnosed with dementia
  • Have abuse as a main diagnosis, or an abuse that stands in the way of participation in MA&R
  • A forensic psychiatric status
  • Need for translator assistance
  • Do not want to give informed consent

研究组 & 干预措施

Intervention group

Experimental

MA&R - an eight months rehabilitation intervention in addition to standard care and treatment in Community Mental Health Centres in Copenhagen, and psychiatric rehabilitation services in Copenhagen, Odense and Svendborg, Denmark

干预措施: Meaningful Activities and Recovery (Behavioral)

Intervention group

Experimental

MA&R - an eight months rehabilitation intervention in addition to standard care and treatment in Community Mental Health Centres in Copenhagen, and psychiatric rehabilitation services in Copenhagen, Odense and Svendborg, Denmark

干预措施: Standard Care and Treatment (Behavioral)

Control group

Active Comparator

Standard care and treatment in Community Mental Health Centres in Copenhagen, and psychiatric rehabilitation services in Copenhagen, Odense and Svendborg, Denmark

干预措施: Standard Care and Treatment (Behavioral)

结局指标

主要结局

Profiles of occupational engagement in people with severe mental illness (POES-S).

时间窗: Eight months

Activity Engagement (engagement in meaningful daily activities, social roles, and connection to the community). rating is made on nine items expressing activity engagement, for example balance between rest and activity, being able to move between places, and taking initiatives. A four-point rating schedule is used. The range is 9-36, where higher values indicate better outcome

次要结局

  • WHODAS 2.0(Eight months)
  • Manchester Short Assessment of Quality of Life (MANSA).(Eight months)
  • Questionnaire about Process of Recovery (QPR)(Eight months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lene Falgaard Eplov

Head of Research, Associate professor

Amager Hospital

研究点 (4)

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