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

Calo Psychiatric Center

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06730178
Enrollment
24
Registered
2024-12-12
Start date
2009-01-01
Completion date
2009-10-30
Last updated
2024-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Disorder; Insomnia Type

Keywords

Insomnia, Relaxation Training, Generalized Estimating Equation

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.

Interventions

BEHAVIORALrelaxation 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.

Sponsors

Calo Psychiatric Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

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.

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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 59 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
the improvement of relaxation training tape4 weeksParticipants were instructed to perform the treatment in the evening, preferably just before bedtime, total time was 15 minutes.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026