Status:

RECRUITING

Effect of WBT for CI With Depression

Lead Sponsor:

Xuanwu Hospital, Beijing

Conditions:

Chronic Insomnia

Depression Disorders

Eligibility:

All Genders

8+ years

Phase:

NA

Brief 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.

Detailed Description

According to DSM-IV criteria, approximately 6%-10% of the adult population in industrialized countries suffer from chronic insomnia (CI), characterized by difficulties in initiating or maintaining sle...

Eligibility Criteria

Inclusion

  • Diagnosed with Insomnia Disorder according to DSM-5 criteria, with a duration of at least 3 months.
  • Pittsburgh Sleep Quality Index (PSQI) total score \> 5.
  • Age 8 years or older.
  • Educational level of at least junior high school.
  • Voluntarily agree to participate and provide written informed consent.
  • Presence of depressive symptoms, defined as Hamilton Depression Scale (HAMD) score ≥ 16.

Exclusion

  • Presence of severe physical illnesses or major psychiatric disorders, or at risk of suicide.
  • Diagnosed or suspected of having sleep breathing disorders, restless legs syndrome, circadian rhythm sleep disorders, or engaged in shift work.
  • Pregnant or breastfeeding women.
  • Currently undergoing any psychological therapy.

Key Trial Info

Start Date :

November 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

November 1 2025

Estimated Enrollment :

84 Patients enrolled

Trial Details

Trial ID

NCT06968013

Start Date

November 1 2024

End Date

November 1 2025

Last Update

May 13 2025

Active Locations (1)

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1

Xuanwu Hospital, Capital Medical University

Beijing, China, 100053