Clinical trial NCT06730178: Using Generalized Estimating Equation Analysis in a Study of Relaxation Training in Patients With Insomnia.
Official title: Calo Psychiatric Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disorder; Insomnia Type
Keywords: Insomnia
Relaxation Training
Generalized Estimating Equation
Lead sponsor: Calo Psychiatric Center
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the improvement of relaxation training tape
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Calo Psychiatric Center
name: For-Wey Lung, MD, ScD
role: PRINCIPAL_INVESTIGATOR
References: