Effectiveness of an Occupation-based Sleep Program for People With Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Chinese Version Pittsburgh Sleep Quality Index (C-PSQI).
研究概览
简要总结
Introduction. Sleep problems are a health issue worldwide. Based on the Person-Environment-Occupation-Performance model and the theory of occupational balance, we developed an occupation-based sleep program to address several objectives by lifestyle intervention: 1) minimize the influence of bodily function on sleep; 2) promote an environment conductive to sleep; and 3) restructure daytime activity with a focus on occupational balance through psychoeducation and lifestyle coaching.
Method. This study aims to evaluate the effectiveness of an occupation-based sleep intervention on sleep pattern, mood, and occupational balance among community-dwelling adults with insomnia when compared with other, more usual, forms of treatment, typically focused on education, sleep hygiene, and relaxation. A total of 42 subjects were recruited: 22 for the intervention group and 20 for the treatment as usual group.
详细描述
The goal of this study is to investigate the effectiveness of occupation-based sleep program for patients with insomnia. It compares the treatment outcomes of sleep pattern, mood, and occupational balance between an intervention group (occupation-based sleep program) and a treatment-as-usual (TAU) group (sleep hygiene education and relaxation training) upon completion of their respective programs and at one-month follow up.
The occupation-based sleep program includes both group and individual sessions. Each group consists of 4 to 6 patients. Each session last for two hours and are held on a weekly basis. Group session focus on sharing information and goal setting to facilitate the formation of good habits and positively restructure lifestyle. Individual coaching sessions aim to follow up on action planning to promote occupational balance.
This study uses a quasi-experimental design. The participants of the intervention group attended the occupation-based sleep program in general outpatient clinic A. Participants in the comparison group received TAU in a general outpatient clinic B of another district. The three time-points for collection of outcome data are at baseline (T1), after the intervention (week 8) (T2), and a one-month post intervention follow up (week 12) (T3). The outcomes will be collected by a blinded assessor who is not involved in the delivery or administration of the study.
Participants The inclusion criteria for recruitment of participants are: 1) diagnosis of insomnia disorder, 2) referral by general practitioner; 3) aged 18 to 65 years old; 4) Insomnia Severity Index score over 14; 5) regularly uses a smart phone, which enable data synchronization with the MiBand2 activity wristband; 6) able to complete self-administered study questionnaires and 7) able to communicate in Cantonese. The exclusion criteria are: 1) diagnosis of severe mental illness; 2) Personal Health Questionnaire 9 (measures depressive symptoms), score over 19 and/or anxiety symptoms (General Anxiety Disorder 7 score over 15); 3) On regular pain medication during the last month, for more than 3 days per week); 4) sleep affected by respiratory disease or 5) regular user of alcohol or addictive substances.
Instruments
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of insomnia disorder
- •Referral by general practitioner
- •Aged 18 to 65 years old
- •Insomnia Severity Index score over 14
- •Regularly uses a smart phone, which enable data synchronization with the MiBand2 activity wristband
- •Able to complete self-administered study questionnaires
- •Able to communicate in Cantonese
排除标准
- •Diagnosis of severe mental illness
- •Personal Health Questionnaire 9 (measures depressive symptoms), score over 19 and/or anxiety symptoms (General Anxiety Disorder 7 score over 15);
- •On regular pain medication during the last month, for more than 3 days per week
- •Sleep affected by respiratory disease
- •Regular user of alcohol or addictive substances.
研究组 & 干预措施
Occupation-based sleep intervention program
A program composed of four occupation-based interactive workshops on sleep, insomnia, lifestyle, and change strategies, plus two individual coaching sessions on lifestyle and sleep hygiene.
干预措施: Occupation-based sleep intervention program (Behavioral)
Insomnia educational program (Treatment as Usual Group)
A program composed of four educational talks on sleep hygiene and relaxation training, plus two individual sessions for the reviewing of sleep patterns.
干预措施: Insomnia Education Program at Integrated Mental Health Clinic (IMHC) (Behavioral)
结局指标
主要结局
Chinese Version Pittsburgh Sleep Quality Index (C-PSQI).
时间窗: Post (8th week)
self-report questionnaire that measures sleep quality. The total scores range from 0 to 21. Higher scores indicate worse sleep quality.
Cantonese Version Insomnia Severity Index (C-ISI)
时间窗: Follow-up (12th week)
self-report questionnaire that measures the severity of insomnia. The score range from 0-28. A higher score indicate more severe insomnia
Chinese Version Pittsburgh Sleep Quality Index (C-PSQI). The total scores range from 0 to 21. Higher scores indicate worse sleep quality.
时间窗: Follow-up (12th week)
self-report questionnaire that measures sleep quality.
MiBand2 Activity Wristband.
时间窗: Follow-up (12th week)
commercial activity monitor (CAM) commonly used for measuring activity level and sleep pattern. There is no definite range for activity level and sleep pattern, but higher activity level and shorter sleep duration indicates a poorer sleep pattern.
Cantonese Version Insomnia Severity Index (C-ISI)
时间窗: Baseline
self-report questionnaire that measures the severity of insomnia. The score range from 0-28. A higher score indicate more severe insomnia
Cantonese Version Insomnia Severity Index (C-ISI)
时间窗: Post (8th week)
self-report questionnaire that measures the severity of insomnia. The score range from 0-28. A higher score indicate more severe insomnia
Chinese Version Pittsburgh Sleep Quality Index (C-PSQI).
时间窗: Baseline
self-report questionnaire that measures sleep quality. The total scores range from 0 to 21. Higher scores indicate worse sleep quality.
MiBand2 Activity Wristband.
时间窗: Baseline
commercial activity monitor (CAM) commonly used for measuring activity level and sleep pattern. There is no definite range for activity level and sleep pattern, but higher activity level and shorter sleep duration indicates a poorer sleep pattern.
MiBand2 Activity Wristband.
时间窗: Post (8th Week)
commercial activity monitor (CAM) commonly used for measuring activity level and sleep pattern. There is no definite range for activity level and sleep pattern, but higher activity level and shorter sleep duration indicates a poorer sleep pattern.
次要结局
- Occupational Balance Questionnaire (OB-Quest)(Follow-up (12th week))
- General Anxiety Disorder 7 (GAD 7).(Follow-up (12th week))
- Personal Health Questionnaire 9 (PHQ9)(Follow-up (12th week))
- Occupational Balance Questionnaire (OB-Quest)(Baseline)
- Occupational Balance Questionnaire (OB-Quest)(Post (8th week))
- Personal Health Questionnaire 9 (PHQ9)(Baseline)
- Personal Health Questionnaire 9 (PHQ9)(Post (8th week))
- General Anxiety Disorder 7 (GAD 7).(Baseline)
- General Anxiety Disorder 7 (GAD 7).(Post (8th week))