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Clinical Trials in China / NCT06968013
Recruiting Not applicable

Effect of WBT for CI With Depression

NCT06968013 · tracked via the Priya Life Science China tracker
Sponsor
Xuanwu Hospital, Beijing
Phase
Not applicable
Started
2024-11-01
Last updated
2025-05-13

Condition(s) studied

Chronic InsomniaDepression Disorders

Investigational drug(s) / intervention(s)

Well-Being TherapySleep Hygiene Education

Well-Being Therapy: Participants will undergo Well-Being Therapy (WBT) sessions once daily for 50 minutes over a period of six weeks. The core elements of WBT include prompting participants to identify instances of well-being, contextualize these experiences using a structured diary, and recognize as well as restructure thoughts, beliefs, and behaviors that prematurely disrupt well-being. Additionally, the specific components of the six dimensions of the Psychological Well-Being (PWB) scale-autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance-are systematically integrated into different therapy sessions

Sleep Hygiene Education: Participants will receive Sleep Hygiene Education (SHE) alone for 6 weeks. SHE involves education on maintaining consistent sleep schedules, creating a sleep-conducive environment, reducing stimulant use (e.g., caffeine, alcohol), and promoting healthy daily routines to improve sleep quality.

Study summary

This randomized controlled trial aims to explore the therapeutic effects of Well-Being Therapy (WBT) on patients with Chronic Insomnia accompanied by depressive symptoms.

Eligibility

Sex
ALL
Min age
8 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Diagnosed with Insomnia Disorder according to DSM-5 criteria, with a duration of at least 3 months. 2. Pittsburgh Sleep Quality Index (PSQI) total score \> 5. 3. Age 8 years or older. 4. Educational level of at least junior high school. 5. Voluntarily agree to participate and provide written informed consent. 6. Presence of depressive symptoms, defined as Hamilton Depression Scale (HAMD) score ≥ 16. Exclusion Criteria: 1. Presence of severe physical illnesses or major psychiatric disorders, or at risk of suicide. 2. Diagnosed or suspected of having sleep breathing disorders, restless legs syndrome, circadian rhythm sleep disorders, or engaged in shift work. 3. Pregnant or breastfeeding women. 4. Currently undergoing any psychological therapy.

Primary outcome measure(s)

  • Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at 6 Weeks — Baseline and Week 6
    The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire designed to evaluate sleep quality over a one-month period. It consists of 19 items grouped into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored on a scale of 0 to 3, and the total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.

Trial sites (1)

FacilityCityRegionStatus
Xuanwu Hospital, Capital Medical University Beijing China Recruiting

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Other trials for the same condition

Effects of Tai Chi on Chronic Insomnia Disorder Combined With Hyperarousal/Anxiety Recruiting
Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms Recruiting
Clinical Study of Compound Ciwujia Granules in the Treatment of Depression Active, not recruiting
The Impact of Beta-band Transcranial Alternating Current Stimulation (tACS) on Impulse Inhibition in Adolescents With Non-suicidal Self-injury Recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06968013 on ClinicalTrials.gov ↗ ← All trials in China