Evaluating the Effectiveness of Intervention Based on the Model of Occupational Harmony in Patients With Sleep Disorders

NCT06558929 | Active Not Recruiting

• 1 other identifier: MOHar-CRSWD-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn the effectiveness of an intervention based on the Model of Occupational Harmony (MOHar) in treating patients with sleep disorders. The main questions it aims to answer are:

• Does intervention based on the MOHar improve sleep quality in patients with sleep disorders?
• Does intervention based on the MOHar improve the quality of life in patients with sleep disorders? Researchers will compare the intervention based on the MOHar to conventional treatment to see if the intervention works to treat sleep disorders. Participants will:
• Participate in an occupational therapy program for 6 weeks (including group therapy, individual treatment, and daily occupational tasks)
• Complete questionnaires at 1, 3, and 6 months after the program for follow-up

Conditions

Circadian Rhythm Sleep-Wake Disorder

Outcome Measures

Primary Outcomes (3)

• Insomnia Severity Index

  Using the ISI to measure sleep quality

  6 months

• Pittsburgh Sleep Quality Index

  Using the PSQI to measure sleep quality

  6 months

• 36-Item Short Form Survey (SF-36)

  Using the SF-36 to measure quality of life

  6 months

Study Arms (1)

Occupational Intervention Group

EXPERIMENTAL

The intervention group will participate in a 6-week occupational therapy program, which includes 3 group treatment sessions, 1 individual treatment session, and daily occupational tasks.

Behavioral: Occupational Therapy; Other: Conventional Treatment

Interventions

Occupational Therapy BEHAVIORAL

Participants will redesign their daily routine with support from occupational therapists and an online health management platform.

Occupational Intervention Group

Conventional Treatment OTHER

Participants will receive conventional treatment and education on sleep hygiene.

Occupational Intervention Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• self-reported difficulties with sleep quality
• active sleep disturbance as indicated by a PSQI \> 5 or an ISI ≥ 8 at screening
• able to participate in research independently or with the assistance of a caregiver
• participate voluntarily in the study and sign an informed consent form

You may not qualify if:

• unable to cooperate with the study process due to cognitive, sensory, and motor dysfunction
• unable to skillfully use wearable monitoring devices or smartphones
• diagnosed with severe cardiac, liver, and kidney dysfunction and nervous system diseases
• have cardiac pacemakers
• being pregnant
• participating in other clinical trials

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 19, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)