Self-administered Acupressure for Insomnia Disorder

NCT03623438 | Completed

• 1 other identifier: SelfAcupInsomnia
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insomnia Chronic

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• The 7-day daily sleep diary

  Baseline, Week 4, Week8

• Hospital Anxiety and Depression Scale (HADS)

  Baseline, Week 4, Week8

• The 7-day actigraphy

  Baseline, Week 4, Week8

• Short Form- 6 Dimensions

  Baseline, Week 4, Week8

Other Outcomes (1)

• Credibility of Treatment Rating Scale

  Baseline

Study Arms (2)

Self-administered acupressure group

EXPERIMENTAL

Subjects will attend two weekly 120-minute of self-administered acupressure training

Behavioral: Self-administered acupressure group

Sleep hygiene education (SHE) group

ACTIVE COMPARATOR

Subjects will attend two weekly 120-minute of sleep hygiene education

Behavioral: Sleep hygiene education (SHE) group

Interventions

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.

Self-administered acupressure group

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.

Sleep hygiene education (SHE) group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese Hong Kong residents who are able to communicate in Cantonese or Putonghua;
• Aged 18-64 years;
• A current clinical DSM-5 diagnosis of insomnia disorder according to the Brief Insomnia Questionnaire (BIQ)
• Insomnia Severity Index total score of at least 10 indicating insomnia at the clinical level; and
• Willing to give informed consent and comply with the trial protocol.

You may not qualify if:

• Receiving acupuncture or practitioner-delivered acupressure treatment in the past 6 months;
• Pregnancy;
• Cognitive impairment as indicated by a Mini Mental State Examination ≤23;
• At significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (score ≥3) ;
• No comorbid sleep disorders primarily requiring other treatment, such as sleep apnea or narcolepsy;
• Taking herbal remedies, over-the-counter medication, or psychotropic drugs that target insomnia within the 2 weeks prior to baseline; and
• Shift-workers/

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

School of Nursing, the Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 9, 2018
• Study Start: September 1, 2018
• Primary Completion: August 30, 2020
• Study Completion: January 12, 2021
• Last Updated: January 14, 2021

Record last verified: 2019-10

Locations

HK (1)