Illness Management and Recovery (IMR) in Danish Community Mental Health Centres: Protocol of a Randomized, Assessor-blinded Multi-centre Clinical Trial of a Recovery-oriented Program for People With Schizophrenia or Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Global Assessment of Function
研究概览
简要总结
The aim of this trial is to evaluate the effectiveness of the Illness Management and Recovery program for people diagnosed with schizophrenia or bipolar disorder in according to their level of functioning.
详细描述
Background: Illness Management and Recovery (IMR) is a curriculum-based psychosocial intervention designed as structured program with a recovery-oriented approach. The aim of IMR is to rehabilitate people with severe mental illnesses by helping them acquire knowledge and skills in managing their illness and achieve personal recovery goals. Previous randomised clinical trials indicate that IMR can be implemented with a good effect and a high fidelity though further trials are crucial to demonstrate the potential effectiveness of IMR.
Methods/Design: The trial design is a randomised, assessor-blinded, multi-centre, clinical trial of the IMR program compared with treatment as usual for 200 participants diagnosed with schizophrenia or bipolar disorder under the care of two community mental health centres in the Capital Region of Denmark. The primary outcome is level of functioning at the end of treatment and at follow-up 21 months after baseline. The secondary outcomes are disease symptoms; use of alcohol/drugs; individual meaning of recovery; hope; hospital admissions and out-patient psychiatric treatment at the end of treatment and at follow-up 21 months after baseline.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults (age 18+)
- •both sexes
- •associated with one of the two participating community mental health centres
- •diagnosed following the ICD-10 criteria of schizophrenia or bipolar disorder
- •able to speak and understand Danish
- •giving informed consent verbally and in writing
排除标准
- •have a guardian or a forensic psychiatric arrangement
- •comorbidity with the ICD-10 criteria of the diagnoses of dementia or mental retardation
- •a large-scale substance abuse - if later on the abuse is under control inclusion in the trial will be possible
- •a current home of supported housing - since the treatment as usual given to this group of patients is significant different from patients living independently
- •a current involvement in a psycho-educational course - patients are eligible for participation in the trial after the psycho-educational course has ended if they meet the inclusion criteria at this point
- •not given informed consent.
研究组 & 干预措施
IMR program
The program is organised into 11 curriculum topic areas: recovery strategies, practical facts about mental illness, the stress-vulnerability model, building social support, using medication effectively, drug and alcohol use, reducing relapses, healthy lifestyle, coping with stress, coping with problems and symptoms, and getting your needs met in the mental health system. In this Danish trial IMR will be implemented in group format with 10 patients assigned to each group and two IMR facilitators, and the IMR program will require nine months of weekly sessions to complete.
干预措施: Illness Management and Recovery (IMR) (Behavioral)
Treatment as usual
Patients randomised to the control group will get 'treatment as usual' only. This means individual adapted interdisciplinary treatment including medication, individual support, occupational therapy, psycho-education and group therapy.
结局指标
主要结局
Global Assessment of Function
时间窗: 9 months and 21 months
次要结局
- Hamilton Rating Scale for Depression(9 & 21 months)
- Personal and Social Performance(9 and 21 months)
- PANSS(9 and 21 months follow-up)
- Young Mania Rating Scale(9 & 21 months)
- The Adult State Hope Scale(9 and 21 months)
- IMR Scale(9 and 21 months follow-up)
- Mental Health Recovery Measure(9 and 21 months)
研究者
Lene Falgaard Eplov
Head of Research, Associate professor
Amager Hospital