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The study is to evaluate the clinical effects of self-administered acupressure for treating insomnia disorder delivered by a training course. Subjects will be offered either self-administered acupressure training or sleep hygiene education. Their insomnia severity will be compared after 8 weeks.
Objectives: To evaluate the clinical effects of self-administered acupressure for treating insomnia disorder delivered by a training course.
Hypothesis: Subjects in the self-administered acupressure group will have greater improvement in insomnia symptoms and daytime impairment than those in the sleep hygiene education (SHE) group at 4 weeks and 8 weeks.
Design and subjects: A randomized controlled trial. 184 subjects with insomnia disorder recruited from the community will be randomized to self-administered acupressure or SHE groups in a 1: 1 ratio.
Study instrument: Insomnia Severity Index (ISI) will be used to assess insomnia symptoms and daytime impairment.
Interventions: Subjects in the self-administered acupressure group will attend two training lessons (2-hour each) to learn self-administered acupressure and practice it every night for 4 weeks; subjects in the SHE group will receive sleep hygiene education with the schedule and duration that are same to the self-administered acupressure group.
Main outcome measures: The primary outcome measure is the ISI score. Other measures include sleep parameters by subjective sleep diary and objective actigraphy, Hospital Anxiety and Depression Scale, and SF-6D at 4 and 8 weeks. Acceptability and compliance of self-administered acupressure will be evaluated.
Data Analysis: Differences in the questionnaire scores, subjective and objective sleep parameters will be examined using a mixed-effects model.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-administered acupressure group | Experimental | Subjects will attend two weekly 120-minute of self-administered acupressure training |
|
| Sleep hygiene education (SHE) group | Active Comparator | Subjects will attend two weekly 120-minute of sleep hygiene education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-administered acupressure group | Behavioral | Subjects in the self-administered acupressure group will attend an acupressure training course (2 sessions, 2 hours each) to learn self-administered acupressure, which will then be performed every night for 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index (ISI) | The ISI is a seven-item self-rating scale. The subjects rate the severity of insomnia, distress and functional impairment associated with insomnia on a 5-point Likert scale. The total score will be reported. The score ranges from 0 to 28; a higher score indicates a more severe condition. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| The 7-day daily sleep diary | The standardized sleep diary records the daily sleep parameters. | Baseline, Week 4, Week8 |
| Hospital Anxiety and Depression Scale (HADS) | The HADS is a 14-item self-administrated questionnaire, which assesses the severity of depressive and anxiety symptoms. The anxiety and depression subscore will be reported. The subscore ranges from 0 to 21; a higher score indicates a more severe condition. |
| Measure | Description | Time Frame |
|---|---|---|
| Credibility of Treatment Rating Scale | The 4-item Credibility of Treatment Rating Scale will be used to assess subjects' expectation towards the intervention in both groups. The score of each item will be reported. The score of each item ranges from 1 to 6. A higher score indicates a higher confidence toward the intervention. | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Nursing, the Hong Kong Polytechnic University | Hong Kong | Hong Kong |
Upon request
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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| Sleep hygiene education (SHE) group | Behavioral | Subjects in the comparison group will receive sleep hygiene education (2 sessions, 2 hours each, same as the treatment group) and be reminded to follow the sleep hygiene practice daily for 4 weeks. |
|
| Baseline, Week 4, Week8 |
| The 7-day actigraphy | An actigraph is a watch-like device used to estimate sleep-wake schedules by measuring activity. | Baseline, Week 4, Week8 |
| Short Form- 6 Dimensions | It is a preference-based measure of health derived from the Short Form-36. It includes six dimensions: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality. The total score will be reported. The score ranges from 0 to 1; a higher score indicates a better outcome. | Baseline, Week 4, Week8 |
| D001523 |
| Mental Disorders |