Effect of WBT for CI With Depression

NCT06968013 | Recruiting

• 1 other identifier: WBT-CI-D-2025
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Insomnia; Depression Disorders

Keywords

Chronic Insomnia; Depression Disorders; Well-Being Therapy

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at 6 Weeks

  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.

  Baseline and Week 6

Secondary Outcomes (11)

• Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Scores at 3, 6, and 12 Months

  Baseline, 3 months, 6 months, and 12 months

• Change from Baseline in Hamilton Depression Scale-17 (HAMD-17) Scores

  Baseline, Week 6, 3 months, 6 months, and 12 months

• Change from Baseline in Beck Depression Inventory-II (BDI-II) Scores

  Baseline, Week 6, 3 months, 6 months, and 12 months

• Change from Baseline in Beck Anxiety Inventory (BAI) Scores

  Baseline, Week 6, 3 months, 6 months, and 12 months

• Change from Baseline in Patient Health Questionnaire-4 (PHQ-4) Scores

  Baseline, Week 6, 3 months, 6 months, and 12 months

Study Arms (2)

WBT-CI

EXPERIMENTAL

Behavioral: Well-Being Therapy

SHE-CI

ACTIVE COMPARATOR

Behavioral: Sleep Hygiene Education

Interventions

Well-Being Therapy BEHAVIORAL

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

WBT-CI

Sleep Hygiene Education BEHAVIORAL

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.

SHE-CI

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

RECRUITING

Related Publications (1)

• Liu X, Song P, Yin L, Wang K, Zhu B, Huang X, Niu Y, Leng H, Xue Q, Peng M, Min B, Shangguan F, Zhang P, Zhao W, Wang H, Lv J, Yang M, Wang P, Li D, Gao X, Feng K, Yun K, Cosci F, Wang H. The Role of Online Well-Being Therapy in Overcoming Allostatic Overload in Medical Workers: A Pilot Randomized Controlled Study. Psychother Psychosom. 2024;93(5):316-327. doi: 10.1159/000540924. Epub 2024 Sep 23.

  PMID: 39312891 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Hongxing Wang, MD & PhD

CONTACT

+86 13911127385; wanghongxing@xwh.ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: November 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)