Effect of Acceptance and Commitment Therapy-based Lifestyle Counselling Programme for People With Early Psychosis on Physical Activity: A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Physical activity
研究概览
简要总结
This pilot randomized controlled trial aims to determine the feasibility, acceptability and preliminary effects of an Acceptance and Commitment Therapy-based Lifestyle Counselling Programme (ACT-LCP) on the physical and psychosocial health outcomes of patients with early psychosis over a 12-week follow-up.
详细描述
Background: Three-quarters of deaths in psychotic patients are caused by Cardiometabolic Diseases (CMD), including but not limited to cardiac disease, diabetes, and stroke. Globally, the average life expectancy of a psychotic patient is 10 to 20 years shorter than the average life expectancy of those without a psychotic diagnosis. Research has supported that early intervention on lifestyle and cardiometabolic risks is essential to prevent the occurrence of CMD. This study will integrate the framework of Acceptance and Commitment Therapy and Self-Determination Therapy with a healthy-lifestyle intervention programme cultivating autonomous motivation of psychotic patients to live healthier. In addition, the acceptance and mindfulness-based part of ACT would increase the patient's awareness to psychological struggles. While many studies reviewed the ACT's effectiveness in improving mental health and functioning outcomes as well as enhancing physical activity and maintenance of weight reduction for individuals without mental illness, the use of the ACT-based lifestyle intervention in psychotic patients with the framework of Self-Determination Therapy has not even been examined.
Objectives: To determine the feasibility, acceptability and preliminary effects of an Acceptance and Commitment Therapy-based Lifestyle Counselling Programme (ACT-LCP) on the physical and psychosocial health outcomes of patients with early psychosis over a 12-weeks follow-up period.
Hypotheses to be tested: When compared with the Control Group receiving standard care and lifestyle education talk, more participants in the ACT-LCP Group will be physically active, defined as participating in at least 150 minutes/week of moderate to vigorous-intensity of physical activity, at 1-week and at 12-weeks post-intervention. The ACT-LCP group will report improvements in healthy dietary intake, autonomous motivation, psychological flexibility, mental status and quality of life.
Design and subjects: An assessor-blind randomized controlled trial with two-arm, repeated-measures design; 72 Cantonese-speaking patients with early psychosis.
Study Instruments: Validated questionnaires, accelerometer-based wristband activity tracker
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)
盲法说明
Outcome assessors and researchers(and health care providers of the study hospital) are blinded to the group assignment and intervention undertaken and concealed to the participant list.
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
- •at least 18 years of age or above
- •able to understand the nature of the study and give informed consent,
- •able to communicate in Cantonese,
- •have a diagnosis of psychotic disorders (e.g., delusional/brief psychotic disorder, schizotypal disorder, and psychosis not otherwise specified) according to the DSM IV-TR, DSM-V or ICD-10, within 5 years of onset as documented in their clinical/written records;
- •insufficiently active (i.e., <150 minutes of MVPA per week) based on self-reports in a brief screening form, and
- •having used mobile instant-messaging apps (e.g. WhatsApp/Facebook messenger/WeChat) installed on a smartphone.
排除标准
- •have had a record of alcohol abuse and/or substance misuse,
- •poor physical health condition, acute/severe medical diseases seriously reducing their life expectancy or ability to participate,
- •pregnancy or within six months of postpartum,
- •have received (within the past 6 months) or are receiving other physical and psychosocial interventions, and
- •severe psychiatric symptoms appeared in the past month.
研究组 & 干预措施
ACT-LCP Group
An Acceptance and Commitment Therapy-based healthy lifestyle counselling programme (ACT-LCP) and routine psychiatric outpatient/rehabilitation services of the study hospital.
干预措施: Acceptance and Commitment Therapy-based lifestyle counselling programme (Behavioral)
Control Group
A healthy lifestyle talk and routine psychiatric outpatient/rehabilitation services of the study hospital.
干预措施: Healthy lifestyle talk (Behavioral)
结局指标
主要结局
Physical activity
时间窗: Change from baseline assessment to 12 weeks post-intervention
An accelerometer-based wristband activity tracker, the Fitbit Inspire 2, will be used to measure the total number of minutes spent on moderate to vigorous physical activity (MVPA). Examples of MVPA include brisk walking, climbing stairs, dancing or doing household chores (moderate activity), running, fast cycling, fast swimming, or playing sport (vigorous activity).The data are considered valid if the participants wear the Fitbit for ≥10 hours/day on ≥5 consecutive days (4 valid weekdays+1 valid weekend day). Higher minutes indicate more physically active.
次要结局
- Psychological flexibility(Change from baseline assessment to 12 weeks post-intervention)
- Healthy dietary intake(Change from baseline assessment to 12 weeks post-intervention)
- Autonomous motivation(Change from baseline assessment to 12 weeks post-intervention)
- Mental status(Change from baseline assessment to 12 weeks post-intervention)
- Perceived quality of life(Change from baseline assessment to 12 weeks post-intervention)
研究者
Yuen Yu CHONG
Assistant Professor
Chinese University of Hong Kong