Clinical trial Recruiting at 1 site Interventional Ages 8 and up

Therapeutic effects of Well-Being Therapy for chronic insomnia with depression

Official title: Investigating on the Efficacy of Well-Being Therapy (WBT) for Chronic Insomnia (CI) With Depressive Symptoms

Run by Xuanwu Hospital, Beijing · NCT06968013 · Data updated 2026-11-12

This study is testing if Well-Being Therapy can help people with chronic insomnia and depression feel better after six sessions of treatment.

More Depression Disorders trials

Quick facts

Study typeInterventional
Ages8 Years and up
SexAll
Enrollment84 (estimated)
SponsorXuanwu Hospital, Beijing
Academic / other
Locations1 site (Beijing)
StatusRecruiting
StartedNovember 1, 2024
Main results expectedOctober 1, 2025
Study endsNovember 1, 2025
Registry record updatedMay 13, 2025
Trial IDNCT06968013 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals aged 8 years or older diagnosed with chronic insomnia and experiencing depressive symptoms.

Probably not a fit

Patients with severe physical illnesses, major psychiatric disorders, or those currently undergoing psychological therapy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial investigates the effects of Well-Being Therapy (WBT) on patients suffering from chronic insomnia accompanied by depressive symptoms. Chronic insomnia affects a significant portion of the adult population and is often linked with psychiatric issues, particularly depression. The study aims to evaluate the effectiveness of six sessions of WBT, which includes self-monitoring, cognitive restructuring, and homework assignments, as a non-pharmacological intervention. Participants will also receive education on sleep hygiene to enhance treatment outcomes.

Why it matters

Potential benefit: If successful, this approach could provide a non-drug alternative for managing chronic insomnia and its associated depressive symptoms.

How similar studies have gone: Previous research has shown that Well-Being Therapy can effectively alleviate stress in populations with high allostatic load, suggesting potential for success in this context.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Xuanwu Hospital, Capital Medical University
    Beijing, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.