NCT04940975

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
Last Updated

July 9, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

March 5, 2021

Last Update Submit

July 5, 2021

Conditions

Insomnia, PrimaryInsomnia

Keywords

InsomniaOccupational TherapySleepEvaluation

Outcome Measures

Primary Outcomes (9)

  • Cantonese Version Insomnia Severity Index (C-ISI)

    self-report questionnaire that measures the severity of insomnia. The score range from 0-28. A higher score indicate more severe insomnia

    Baseline

  • Cantonese Version Insomnia Severity Index (C-ISI)

    self-report questionnaire that measures the severity of insomnia. The score range from 0-28. A higher score indicate more severe insomnia

    Post (8th week)

  • Cantonese Version Insomnia Severity Index (C-ISI)

    self-report questionnaire that measures the severity of insomnia. The score range from 0-28. A higher score indicate more severe insomnia

    Follow-up (12th week)

  • Chinese Version Pittsburgh Sleep Quality Index (C-PSQI).

    self-report questionnaire that measures sleep quality. The total scores range from 0 to 21. Higher scores indicate worse sleep quality.

    Baseline

  • Chinese Version Pittsburgh Sleep Quality Index (C-PSQI).

    self-report questionnaire that measures sleep quality. The total scores range from 0 to 21. Higher scores indicate worse sleep quality.

    Post (8th week)

  • Chinese Version Pittsburgh Sleep Quality Index (C-PSQI). The total scores range from 0 to 21. Higher scores indicate worse sleep quality.

    self-report questionnaire that measures sleep quality.

    Follow-up (12th week)

  • MiBand2 Activity Wristband.

    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.

    Baseline

  • MiBand2 Activity Wristband.

    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.

    Post (8th Week)

  • MiBand2 Activity Wristband.

    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.

    Follow-up (12th week)

Secondary Outcomes (9)

  • Occupational Balance Questionnaire (OB-Quest)

    Baseline

  • Occupational Balance Questionnaire (OB-Quest)

    Post (8th week)

  • Occupational Balance Questionnaire (OB-Quest)

    Follow-up (12th week)

  • Personal Health Questionnaire 9 (PHQ9)

    Baseline

  • Personal Health Questionnaire 9 (PHQ9)

    Post (8th week)

  • +4 more secondary outcomes

Study Arms (2)

Occupation-based sleep intervention program

EXPERIMENTAL

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.

Behavioral: Occupation-based sleep intervention program

Insomnia educational program (Treatment as Usual Group)

ACTIVE COMPARATOR

A program composed of four educational talks on sleep hygiene and relaxation training, plus two individual sessions for the reviewing of sleep patterns.

Behavioral: Insomnia Education Program at Integrated Mental Health Clinic (IMHC)

Interventions

Occupation-based sleep intervention programBEHAVIORAL

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.

Occupation-based sleep intervention program
Insomnia Education Program at Integrated Mental Health Clinic (IMHC)BEHAVIORAL

A program composed of four educational sessions on sleep and insomnia, plus relaxation training, plus two individual review sessions on sleep hygiene with participant.

Insomnia educational program (Treatment as Usual Group)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Central Kowloon General Out-Patient Clinic (GOPC)

Hong Kong, Hong Kong

Location

Yau Ma Tai General Out-Patient Clinic (GOPC)

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Andrew MH Siu, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2021

First Posted

June 28, 2021

Study Start

June 18, 2018

Primary Completion

December 11, 2019

Study Completion

December 11, 2019

Last Updated

July 9, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

HK(2)