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

Not Applicable

Not yet recruiting

• Conditions: Circadian Rhythm Sleep-Wake Disorder

• Registration Number: NCT06558929
• Lead Sponsor: Peking University First Hospital

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 circadian rhythm sleep-wake disorders (CRSWD). The main questions it aims to answer are:

* Does intervention based on the MOHar can improve sleep quality in patients with CRSWD?

* Does intervention based on the MOHar can improve the quality of life in patients with CRSWD?

Researchers will compare intervention based on the MOHar to conventional treatment to see if the intervention works to treat CRSWD.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-15
• Last Update Submitted: 2024-08-18
• Study First Posted: 2024-08-19
• Last Update Posted: 2024-08-20
• Study Start: 2024-09-30
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• ≥18 years of age
• meet the diagnostic criteria for CRSWD
• able to participate in research independently or with the assistance of a caregiver
• participate voluntarily in the study and sign an informed consent form

Exclusion Criteria

• 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 mental disorders such as anxiety and depression
• diagnosed with severe cardiac, liver, and kidney dysfunction and nervous system diseases
• have cardiac pacemakers
• being pregnant
• participating in other clinical trials

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index	6 months	Using the PSQI to measure sleep quality
Insomnia Severity Index	6 months	Using the ISI to measure sleep quality
36-Item Short Form Survey (SF-36)	6 months	Using the SF-36 to measure quality of life

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China