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Self-acupressure for Insomnia

Primary Purpose

Insomnia, Acupressure

Status

Unknown status

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

Self-acupressure

Sleep hygiene education

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Randomized controlled trial, Acupressure, Self-help

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

(1) Chinese Hong Kong residents who are able to communicate in Cantonese or Putonghua;
(2) Aged 18 - 65 years;
(3) A current clinical Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5) diagnosis of insomnia disorder according to the Brief Insomnia Questionnaire (BIQ), a validated diagnostic tool. (The criteria include having difficulties in falling asleep, difficulties in staying asleep, or early morning awakening with clinically significant consequences for daily life for at least 3 months.)
(4) Insomnia Severity Index total score of at least 10 indicating insomnia at the clinical level; and
(5) Willing to give informed consent and comply with the trial protocol.

Exclusion Criteria:

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

Sites / Locations

School of Nursing, the Hong Kong Polytechnic UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Self-acupressure Group

Sleep Hygiene Education Group

Arm Description

Subjects in this group will attend two weekly 120-minute self-acupressure training sessions in a classroom at the School of Nursing, the Hong Kong Polytechnic University. The subjects will be instructed on how to perform the self-acupressure treatment by a trained instructor. To enhance interaction and ensure the quality of teaching, each course will be conducted in a small group of 6 participants. Subjects will perform self-acupressure daily for 4 consecutive weeks.

To control the contact time with professional person in the treatment group, participants in this group will receive two sessions of 120-minute sleep hygiene training session. The participants will be asked to follow the health hygiene instructions daily for 4 consecutive weeks.

Outcomes

Primary Outcome Measures

Insomnia Severity Index (ISI)

The ISI is a seven-item self-rating scale. The subjects rate the severity of insomnia, the distress, and the functional impairment associated with insomnia on a 5-point Likert scale.

Secondary Outcome Measures

The 7-day daily sleep diary

The standardized sleep diary records the bedtime and rising time, from which the total time in bed (TIB) can be calculated. Subjects will be asked to estimate sleep-onset latency, wake after sleep onset, and total sleep time (TST). Sleep efficiency will be calculated as (TST/TIB * 100%).

Hospital Anxiety and Depression Scale (HADS)

The HADS is a 14-item self-administrated questionnaire, which assess the severity of depressive and anxiety symptoms.

Short Form-6D (SF-6D)

SF-6D is composed of six multi-level dimensions: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality.

Full Information

NCT ID

NCT03053648

First Posted

February 13, 2017

Last Updated

February 14, 2017

Sponsor

The Hong Kong Polytechnic University

1. Study Identification

Unique Protocol Identification Number

NCT03053648

Brief Title

Self-acupressure for Insomnia

Official Title

Self-acupressure for Insomnia: A Pilot Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Unknown status

Study Start Date

December 1, 2016 (Actual)

Primary Completion Date

March 3, 2017 (Anticipated)

Study Completion Date

March 31, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Abstract Objectives: To explore the clinical effects of self-acupressure for treating insomnia delivered by a training course. Hypothesis: Subjects who have participated in the self-acupressure training course will have greater improvement in insomnia symptoms and daytime impairment than the sleep hygiene education control group at 4 and 8 weeks. Design and subjects: A pilot randomized controlled trial. Subjects with insomnia will be recruited from the community. 30 subjects will be randomized to self-acupressure and sleep hygiene education control 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-acupressure group will attend two training sessions to learn self-acupressure and will practice self-acupressure every night for 4 weeks; subjects in the sleep hygiene education control group will receive two training sessions to learn sleep hygiene practice. Main outcome measures: The primary outcome measure is the ISI score. Other measures include sleep parameters using subjective sleep diary, Hospital Anxiety and Depression Scale, and SF-6D at 4 and 8 weeks. Acceptability and sustainability of self-acupressure will also be evaluated. Data Analysis: Differences in the questionnaire scores, subjective sleep parameters will be examined using a mixed-effects model.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia, Acupressure

Keywords

Insomnia, Randomized controlled trial, Acupressure, Self-help

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

All of the assessments in this study will be self-completed. The researchers who perform the assessment and analysis will be blinded to group allocation.

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Self-acupressure Group

Arm Type

Experimental

Arm Description

Arm Title

Sleep Hygiene Education Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Self-acupressure

Intervention Description

The subjects will be told to perform self-acupressure 30 min before sleep for 20 min every night for 4 weeks. Telephone follow-up will be made twice a week by the trained student research assistant during the 4-week treatment period to remind subjects to practice self-acupressure.

Intervention Type

Other

Intervention Name(s)

Sleep hygiene education

Intervention Description

A training hand-out will be provided to each subject. The hand-outs included manualized sleep hygiene instructions. A registered nurse who has been trained by a clinical psychologist will be the instructor on sleep hygiene and activity scheduling. To enhance interaction and ensure the quality of teaching, each course will be conducted in a group of 5 participants.

Primary Outcome Measure Information:

Title

Insomnia Severity Index (ISI)

Description

The ISI is a seven-item self-rating scale. The subjects rate the severity of insomnia, the distress, and the functional impairment associated with insomnia on a 5-point Likert scale.

Time Frame

7 days

Secondary Outcome Measure Information:

Title

The 7-day daily sleep diary

Description

Time Frame

7 days

Title

Hospital Anxiety and Depression Scale (HADS)

Description

The HADS is a 14-item self-administrated questionnaire, which assess the severity of depressive and anxiety symptoms.

Time Frame

7 days

Title

Short Form-6D (SF-6D)

Description

SF-6D is composed of six multi-level dimensions: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality.

Time Frame

4 weeks

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: (1) Chinese Hong Kong residents who are able to communicate in Cantonese or Putonghua; (2) Aged 18 - 65 years; (3) A current clinical Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5) diagnosis of insomnia disorder according to the Brief Insomnia Questionnaire (BIQ), a validated diagnostic tool. (The criteria include having difficulties in falling asleep, difficulties in staying asleep, or early morning awakening with clinically significant consequences for daily life for at least 3 months.) (4) Insomnia Severity Index total score of at least 10 indicating insomnia at the clinical level; and (5) Willing to give informed consent and comply with the trial protocol. Exclusion Criteria: (1) Receiving acupuncture or practitioner-delivered acupressure treatment in the past 6 months; (2) Pregnancy; (3) Cognitive impairment as indicated by a Mini Mental State Examination ≤ 23; (4) At significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (score ≥ 3); (5) No comorbid sleep disorders primarily requiring other treatment, such as sleep apnea or narcolepsy; and (6) Taking herbal remedies, over-the-counter medication, or psychotropic drugs that target insomnia within the 2 weeks prior to baseline.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wing-Fai Yeung

jerry-wf.yeung@polyu.edu.hk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wing-Fai Yeung

Organizational Affiliation

The Hong Kong Polytechnic University

Official's Role

Principal Investigator

Facility Information:

Facility Name

School of Nursing, the Hong Kong Polytechnic University

City

Hong Kong

Country

Hong Kong

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wing-Fai Yeung

jerry-wf.yeung@polyu.edu.hk

12. IPD Sharing Statement

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Self-acupressure for Insomnia

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