Effects of Relaxation Training and Stimulus Control in Chronic Insomnia Patients With Hyperarousal and Maladaptive Sleep Patterns

Xuanwu Hospital, Beijing1 site in 1 country88 target enrollmentNovember 1, 2024

ConditionsChronic Insomnia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Insomnia
Sponsor: Xuanwu Hospital, Beijing
Enrollment: 88
Locations: 1
Primary Endpoint: The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks.
Status: Recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study aims to validate the effect of relaxation training and stimulus control on reducing hyperarousal states and improving maladaptive sleep behaviors.

Detailed Description

Relaxation training typically includes techniques such as breathing exercises, muscle relaxation, and mindfulness meditation to help patients reduce levels of physical and psychological tension, promote relaxation, and create favorable conditions for sleep onset. Stimulus control aims to break the negative association between the bed and insomnia, and rebuild a positive association between the bed and sleep.

Registry

clinicaltrials.gov

Start Date

November 1, 2024

End Date

November 1, 2025

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Xuanwu Hospital, Beijing

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Meet the diagnostic criteria for insomnia disorder according to DSM-
•Pittsburgh Sleep Quality Index (PSQI) total score \>
•Age ≥ 18 years, with at least a middle school education level.
•Anxiety symptoms meeting HAMA ≥
•"Self-developed 8-item questionnaire on maladaptive sleep behaviors" used to assess "maladaptive sleep behaviors."
•Voluntarily participate in this study and sign an informed consent form.

Exclusion Criteria

•Individuals with severe physical illnesses or severe mental disorders, at risk of suicide.
•Clinically diagnosed or suspected sleep-related breathing disorders, restless leg syndrome, and sleep-wake rhythm disorders, as well as shift workers.
•Pregnant or lactating women.
•Currently undergoing any psychological therapy.

Outcomes

Primary Outcomes

The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks.

Time Frame: Baseline, 6 weeks

The PSQI consists of 7 factors ranging from 0 to 3 points, and the total score ranges from 0 to 21 with higher scores indicating poorer quality.

Secondary Outcomes

The change of PSQI total scores from baseline to 3 months, 6 months, and 12 months.(Baseline, 3 months, 6 months, and 12 months)
The change of Insomnia severity index (ISI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
The change of sleep efficiency from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
The change of Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
The change of Snaith-Hamilton Pleasure Scale (SHAPS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
The change of Short Form 36 (SF-36) total scores from baseline to 6 weeks, 3 months, 6 months, 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months.)
The change of Patient Health Questionnaire-4 (PHQ-4) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
The change of Beck Depression Inventory (BDI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
The change of Beck Anxiety Inventory (BAI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
The change of Patient Health Questionnaire-15 (PHQ-15) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
The change of 5-item Perceived Deficits Questionnaire-Depression (PDQ-D-5) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)