ClinicalTrials.Veeva

Menu

Effects of Relaxation Training and Stimulus Control in Chronic Insomnia Patients

Capital Medical University logo

Capital Medical University

Status

Enrolling

Conditions

Chronic Insomnia

Treatments

Behavioral: Relaxation training and stimulus control
Behavioral: Sleep hygiene education

Study type

Interventional

Funder types

Other

Identifiers

NCT06658171
RT-SC-insomnia

Details and patient eligibility

About

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

Full 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.

Enrollment

88 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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 criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

88 participants in 2 patient groups

Relaxation training and stimulus control
Experimental group
Treatment:
Behavioral: Relaxation training and stimulus control
Sleep hygiene education
Active Comparator group
Treatment:
Behavioral: Sleep hygiene education

Trial contacts and locations

1

Loading...

Central trial contact

Hongxing Wang, MD & PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems