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NCT Number: NCT06658171

Effects of Relaxation Training and Stimulus Control in Chronic Insomnia Patients

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

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Key information

Conditions

Chronic Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet the diagnostic criteria for insomnia disorder according to DSM-5.
  • Pittsburgh Sleep Quality Index (PSQI) total score > 5.
  • Age ≥ 18 years, with at least a middle school education level.
  • Anxiety symptoms meeting HAMA ≥ 14.
  • "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.

Treatment and study plan

Relaxation training and stimulus control

Behavioral

Relaxation training: Progressive muscle relaxation; Breathing relaxation; Imagery training; Mindfulness relaxation.

Stimulus control: a) Reduce wakeful time in bed and rebuild a positive association between sleepiness and bed; b) Use the bed solely for sleeping and sexual activities; c) Only go to bed when feeling sleepy at night or at the designated sleep time; d) If unable to fall asleep within about 20 minutes of being in bed, leave the bedroom and engage in relaxation activities until feeling sleepy, then return to bed for sleep; if still unable to fall asleep within about 20 minutes, repeat the process; e) Wake up at the same time every morning, including weekends.

Sleep Hygiene Education

Behavioral
  • Sleep until feeling refreshed the next day.
  • Maintain regular exercise and eating habits, avoiding going to bed on an empty stomach.
  • Ensure a comfortable bedroom environment with suitable nighttime temperature, free from light and noise disturbances.
  • Avoid excessive consumption of beverages, alcohol, and smoking at night, and reduce caffeine intake.
  • Avoid bringing problems to bed and refrain from attempting to sleep.
  • Place the alarm clock under the bed or move it away from sight.
  • Avoid daytime napping.

Primary outcomes

  1. 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

  1. The change of PSQI total scores from baseline to 3 months, 6 months, and 12 months.

    Time frame: Baseline, 3 months, 6 months, and 12 months

    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.

  2. The change of Insomnia severity index (ISI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.

    Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months

    The ISI reporting insomnia symptoms severity consists of 7-items on a 5-point Likert scale, and the total score ranges from 0 to 28 with higher scores indicating more severe insomnia.

  3. The change of sleep efficiency from baseline to 6 weeks, 3 months, 6 months, and 12 months.

    Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months

    Sleep efficiency is assessed with the Carney (2012) consensus sleep diary. This is measured in percentage (higher scores indicating better sleep efficiency).

  4. 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.

    Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months

    The DBAS assessing sleep related cognitions in 16 items rated on a 10-point Likert scale, and the total score ranges from 0 to 160 with higher scores indicating more intensive dysfunctional beliefs.

  5. The change of Snaith-Hamilton Pleasure Scale (SHAPS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.

    Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months

    The SHAPS assessing anhedonia consists of 14 items, and the total score ranges from 14 to 56 with higher scores indicating more serious the anhedonia.

  6. The change of Short Form 36 (SF-36) total scores from baseline to 6 weeks, 3 months, 6 months, 12 months.

    Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months.

    The SF-36 quantifying the quality of life in relation to health status consists of 36-items with eight areas covering physical functioning, role limitations brought on by physical issues, bodily pain, general health perceptions, vitality, social functioning, role limitations brought on by emotional issues, and perceived mental health. The total score ranges from 0-100 (the worst possible to the most possible).

  7. The change of Patient Health Questionnaire-4 (PHQ-4) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.

    Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months

    The PHQ-4 comprises a 2-item depression scale and a 2-item anxiety scale. Each instrument can reach values from 0-6. Higher Scores are indicating higher distress.

  8. The change of Beck Depression Inventory (BDI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.

    Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months

    The BDI assessing the existence and severity of symptoms of depression consists of 21 items, and the total score ranges from 0 to 63 with higher scores indicating more severe depressive symptoms.

  9. The change of Beck Anxiety Inventory (BAI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.

    Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months

    The BAI assessing the existence and severity of symptoms of anxiety consists of 21 items, and the total score ranges from 0 to 63 with higher scores indicating more severe anxiety.

  10. The change of Patient Health Questionnaire-15 (PHQ-15) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.

    Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months

    The PHQ-15 measuring somatic distress consists of 15 items, and the total score ranges from 0 to 30 with higher scores indicating more severe somatic distress.

  11. 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.

    Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months

    The PDQ-D-5 assessing perceived cognitive deficits from the patient's perspective consists of 5 items, and the total score ranges from 0 to 20 with higher scores indicating greater perceived deficit.

  12. The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.

    Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months

    The LES assessing the perceived stress and number of stressful life events experienced consists of 48 items which are classified into three dimensions: family life events (28 items), work and study events (13 items), and social events (7 items) with higher scores in LES perceived greater stressfulness.

Study contacts

Contact information is provided by the study sponsor or research team.

Hongxing Wang, MD & PhD

CONTACT

[email protected]

+86 13911127385

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 26, 2024
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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