Recruiting
Effect of WBT for CI With Depression
This randomized controlled trial aims to explore the therapeutic effects of Well-Being Therapy (WBT) on patients with Chronic Insomnia accompanied by depressive symptoms.
ClinicalTrials.gov IDNCT06968013
PhaseNA
Enrollment84
SponsorXuanwu Hospital, Beijing
Age8 Years
SexALL
Conditions studied
Chronic Insomnia, Depression Disorders
About this study
This randomized controlled trial aims to explore the therapeutic effects of Well-Being Therapy (WBT) on patients with Chronic Insomnia accompanied by depressive symptoms.
Interventions
- Behavioral: 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
- Behavioral: 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.
Primary outcomes
- Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at 6 Weeks (Baseline and Week 6)
Eligibility information
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.
Study locations
- Xuanwu Hospital, Capital Medical University, Beijing, 100053 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.