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

Peking University

Status: Active, not recruiting

Conditions: Circadian Rhythm Sleep-Wake Disorder

Treatments: Behavioral: Occupational Therapy; Other: Conventional Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06558929

MOHar-CRSWD-001

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥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

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 severe cardiac, liver, and kidney dysfunction and nervous system diseases
• have cardiac pacemakers
• being pregnant
• participating in other clinical trials

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Occupational Intervention Group

Experimental group

Description:

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.

Treatment:

Other: Conventional Treatment

Behavioral: Occupational Therapy