Braining Study - Implementation of Physical Activity for Patients and Staff in Specialist Psychiatry, Feasibility on Pilot Unit and Effect Evaluation in Randomized Controlled Multi-center Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- The Client Satisfaction Questionnaire-8 (CSQ-8)
研究概览
简要总结
Physical exercise (PE) shows beneficial effects on somatic and psychiatric symptoms. "Braining" is a clinical invention where psychiatric staff exercise together with patients to help patients start and execute PE regularly. In the present study the feasibility of the intervention will be evaluated, how Braining is perceived, and preliminary effects on health and physical activity among patients. The investigators hypothesize that patients' health and physical activity will increase after participation in Braining at the unit. Braining will be implemented at two psychiatric pilot units in Region Stockholm, Sweden. During 6 months patients will be included and treated in 12 weeks PE intervention periods. To measure feasibility patients will answer self-rating questionnaires and be invited to semi structured interviews after receiving the intervention. Health will be measured by physical examination and blood test as well as self-ratings of depression, anxiety, sleep, hypomania, and quality of life before the intervention, every 4 weeks during the intervention, post the intervention, and at follow-up 12 months post the intervention. Physical activity will be rated before, during, after the intervention and at follow-up 12 months post the intervention using International Physical Activity Questionnaires (IPAQ) and Actigraph. All patients that fulfill inclusion criteria at the units will be invited to participate in the study, approximately 50 individuals in total.
详细描述
"Braining" is a clinical invention that helps patients in psychiatry to start and execute physical exercise (PE) regularly in psychiatric care. The core components are basic moderate to vigorous aerobic group training sessions and motivational work led by the psychiatric staff. Braining is used as add-on treatment to regular psychiatric care and is included in the patient care plan. Braining is unique in that it:
- Includes trained psychiatric clinical staff exercising together with patients from both out- and inpatient ward units in daily, moderate to vigorous aerobic group training sessions
- is included in regular healthcare fee, (free of charge)
- includes a motivational and educational visit (as a group seminar or as an individual visit) at the start and end of a twelve-week exercise intervention
- includes regular measurements (self-assessment questionnaires, blood samples, physical and mental health examination and education before and after the twelve-week exercise intervention)
- offers short individual motivating visits before every training session, including assessment of day shape and fitness to participate.
In the present study focus is on the feasibility of the intervention, how Braining is perceived, and preliminary effects on health and physical activity among patients. The research questions are:
- How do patients experience Braining in regards such as feasibility, acceptability, credibility, and effects on health and quality of life?
- How do patients comply to Braining regarding completed training sessions and measurements?
- What preliminary effect does Braining have on mental and physical health, quality of life and level of function in participating patients before compared to after short- and long-term exposure?
Examined from the following points of view:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient at the psychiatric unit
排除标准
- •Severe mental disorder such as ongoing mania, psychosis, and conditions when high risk of suicide or high risk of violence available according to the assessment of psychiatric staff at the unit.
- •Medical conditions such as heart or lung disease, infection, abstinence where heart rate-increasing physical activity is considered contraindicated due to Medical reasons.
- •Physical disability that makes it impossible to move independently to the gym and performing the indicated exercise in the training sessions.
- •Mental disability which means that you can not participate in group training.
- •Difficulty speaking or understanding the Swedish language.
- •Ongoing heavy substance use.
结局指标
主要结局
The Client Satisfaction Questionnaire-8 (CSQ-8)
时间窗: post treatment, 12 weeks after enrollment
Self rated satisfaction of treatment. Minimum value 8, maximum value 32 where higher values indicate greater satisfaction with the treatment.
Alcohol Use Disorders Identification Test AUDIT
时间窗: At follow up 12 months after intervention.
Self rated alcohol use. Minimum value 0, maximum value 32, where higher values indicate higher alcohol use.
Brunnsviken Brief Quality of Life Questionnaire (BBQ)
时间窗: At follow up 12 months after intervention.
Self rated quality of life. Minimum value 0, maximum value 96, where higher values indicate higher quality of life satisfaction.
The Credibility/Expectancy Questionnaire (CEQ)
时间窗: Week 1 of treatment
Self rated Credibility of treatment. Minimum value 3, maximum value 27 for each factor, where higher values indicate greater Credibility/Expectancy of the treatment.
Actigraph GT3x
时间窗: At follow up 12 months after intervention.
Objectively measured physical activity and sedentary time: Total physical activity as counts/day and time spent in sedentary, low, moderate and vigorous intensity as min/day.
International Physical Activity Questionnaires (IPAQ)
时间窗: At follow up 12 months after intervention.
Self-reported physical activity: Total physical activity as Metabolic Energy Turnover (MET)hours/week and three level categories (low, moderate and high).
Patient Health Questionnaire 9 (PHQ-9)
时间窗: At follow up 12 months after intervention.
Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.
Drug Use Disorders Identification Test DUDIT
时间窗: At follow up 12 months after intervention.
Self rated drug use. Minimum value 0, maximum value 44, where higher values indicate higher drug use.
Acceptability of treatment among patients
时间窗: At follow up 3-5 months after inclusion
Semi-structured interviews
次要结局
- Insomnia Severity Index (ISI)(At follow up 12 months after intervention.)
- Negative effects questionnaire (NEQ 20)(post treatment, 12 weeks after enrollment)
- fasting blood sugar (FBS)(At follow up 12 months after intervention.)
- Heart rate (HR)(At follow up 12 months after intervention.)
- Thyroid releasing hormone (TSH)(At follow up 12 months after intervention.)
- World health organization disability assessment schedule (WHODAS 2.0)(At follow up 12 months after intervention.)
- Affective Self Rating Scale (AS-18)(At follow up 12 months after intervention.)
- Blood pressure(At follow up 12 months after intervention.)
- Hemoglobin A1c (HbA1c)(Change from inclusion to follow up 3 months after inclusion)
- Treatment Inventory of costs in patients with psychiatric disorders (TIC-P)(At follow up 12 months after intervention.)
- Body mass index (BMI)(At follow up 12 months after intervention.)
- Blood lipids(At follow up 12 months after intervention.)
- Generalised Anxiety Disorder 7-item scale (GAD-7)(At follow up 12 months after intervention.)
- Waist circumference(At follow up 12 months after intervention.)
- hemoglobin A1c (HbA1c)(At follow up 12 months after intervention.)
- C-reactive protein (CRP)(At follow up 12 months after intervention.)
- Blood liver function test(At follow up 12 months after intervention.)
- EuroQol (EQ-5D-5L) VAS(At follow up 12 months after intervention.)
- Complete blood count(At follow up 12 months after intervention.)