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

NCT06730178 | Completed

• 1 other identifier: 9802
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sleep Disorder; Insomnia Type

Keywords

Insomnia; Relaxation Training; Generalized Estimating Equation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Relaxation training in patients with insomnia

EXPERIMENTAL

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

Interventions

relaxation training BEHAVIORAL

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.

Relaxation training in patients with insomnia

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Calo Psychiatric Center: lead

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• For-Wey Lung, MD, ScD

  Calo Psychiatric Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Of 47 qualified subjects, 24 volunteers took part in this study after the researchers had explained the study process. 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All insomnia patients were asked to complete the insomnia scales. 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. They were treated similarly, four times in total.

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 12, 2024
• Study Start: January 1, 2009
• Primary Completion: October 30, 2009
• Study Completion: October 30, 2009
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share