Using Generalized Estimating Equation Analysis in a Study of Relaxation Training in Patients With Insomnia.

Calo Psychiatric Center

Background: The purpose of this study was to examine the improvement in insomnia patients using Relaxation Training, and to use the Generalized Estimating Equation model (GEE-I) to analyze the results of repeated measurements and observe the difference between the subjective perception and the objective measurement of sleep duration.

Methods: There were 24 subjects diagnosed as insomnia who completed the treatment course and 5 times evaluation. Of the 24 subjects, 7 accepted the sleep electroencephalogram (EEG). Relaxation training shortened the duration of sleep onset time and decreased the frequency of night awakening.

Study Overview

• Status: Completed
• Conditions: Sleep Disorder; Insomnia Type
• Intervention / Treatment: Behavioral: relaxation training

Detailed Description

Of 47 qualified subjects, 24 volunteers took part in this study after the researchers had explained the study process.The patients were asked to keep a sleep diary. In the diaries, they recorded the time they went to bed and fell asleep, the duration to sleep onset (from "go to the bed" to "fall asleep"), the frequency of night waking, the time of getting up, and any medication history. Patients were instructed to perform the treatment in the evening, preferably just before bedtime, total time was 15 minutes.The patients recorded their sleep conditions every day and underwent relaxation training intervention for 4 weeks.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All subjects had been diagnosed as having primary insomnia or insomnia related to medical and psychiatric comorbid diagnoses using the D Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) diagnostic criteria.

Exclusion Criteria:

• Patients who had comorbid serious medical illnesses, and pregnant and lactating women were excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Relaxation training in patients with insomnia; The goals and processes of relaxation training were explained by therapists. The patients were asked to record data before relaxation training, inclusive of all sleep durations, the frequency of night waking, the time needed to fall asleep, and medication history. The insomnia scales were completed again one week later, and the relaxation training started in the second week. The patients recorded their sleep conditions every day and underwent relaxation training intervention for 4 weeks.

Behavioral: relaxation training; The training tapes used were meditation relaxation training tapes translated form Jacobson progressive relaxation technique with copyrights. The tapes were recorded by a male therapist. Participants were instructed to perform the treatment in the evening, preferably just before bedtime, total time was 15 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the improvement of relaxation training tape	Participants were instructed to perform the treatment in the evening, preferably just before bedtime, total time was 15 minutes.	4 weeks

Collaborators and Investigators

• Sponsor: Calo Psychiatric Center
• Investigators: Principal Investigator: For-Wey Lung, MD, ScD, Calo Psychiatric Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2009
• Primary Completion (Actual): October 30, 2009
• Study Completion (Actual): October 30, 2009

Study Registration Dates

• First Submitted: December 8, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Estimated): December 12, 2024

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Insomnia; Relaxation Training; Generalized Estimating Equation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders
• Other Study ID Numbers: 9802

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data in this study are available to other researchers upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No