Effects of Relaxation Training and Stimulus Control in Chronic Insomnia Patients

Last updated: May 5, 2025
Sponsor: Xuanwu Hospital, Beijing
Overall Status: Active - Recruiting

Phase

N/A

Condition

Restless Leg Syndrome

Insomnia

Treatment

Sleep hygiene education

Relaxation training and stimulus control

Clinical Study ID

NCT06658171
RT-SC-insomnia
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Meet the diagnostic criteria for insomnia disorder according to DSM-5.

  2. Pittsburgh Sleep Quality Index (PSQI) total score > 5.

  3. Age ≥ 18 years, with at least a middle school education level.

  4. Anxiety symptoms meeting HAMA ≥ 14.

  5. "Self-developed 8-item questionnaire on maladaptive sleep behaviors" used to assess "maladaptive sleep behaviors."

  6. Voluntarily participate in this study and sign an informed consent form.

Exclusion

Exclusion Criteria:

  1. Individuals with severe physical illnesses or severe mental disorders, at risk ofsuicide.

  2. Clinically diagnosed or suspected sleep-related breathing disorders, restless legsyndrome, and sleep-wake rhythm disorders, as well as shift workers.

  3. Pregnant or lactating women.

  4. Currently undergoing any psychological therapy.

Study Design

Total Participants: 88
Treatment Group(s): 2
Primary Treatment: Sleep hygiene education
Phase:
Study Start date:
November 01, 2024
Estimated Completion Date:
November 01, 2025

Study 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.

Connect with a study center

  • Xuanwu Hospital, Capital Medical University

    Beijing, 100053
    China

    Active - Recruiting

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