Effect of WBT for CI With Depression

NCT ID: NCT06968013

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-11-01

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 sleep accompanied by daytime symptoms persisting for at least four weeks. Chronic insomnia often leads to various psychiatric symptoms, with depressive symptoms being among the most common. For patients with CI and comorbid depressive symptoms, the most common treatment involves the use of antidepressant medications. However, while depressive symptoms may improve, insomnia symptoms often persist.

Among non-pharmacological interventions aimed at promoting psychological well-being, Well-Being Therapy (WBT) stands out as a brief and innovative psychotherapeutic approach. WBT is a structured, manualized, short-term therapy that incorporates self-monitoring of well-being episodes through the use of a diary, cognitive restructuring of interfering thoughts and behaviors, and homework assignments.

Previous research has demonstrated the effectiveness of WBT in alleviating stress in populations experiencing 'allostatic load.' This study seeks to evaluate the therapeutic effects of six WBT sessions on individuals with CI and comorbid depressive symptoms.

Conditions

Chronic Insomnia; Depression Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

WBT-CI

Group Type: EXPERIMENTAL

Well-Being Therapy

Intervention Type: 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

SHE-CI

Group Type: ACTIVE_COMPARATOR

Sleep Hygiene Education

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuanwu Hospital, Capital Medical University

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongxing Wang, MD & PhD

Role: CONTACT

wanghongxing@xwh.ccmu.edu.cn

+86 13911127385

Facility Contacts

Hongxing Wang, MD & PhD

Role: primary

wanghongxing@xwh.ccmu.edu.cn

+86 13911127385

References

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.

Reference Type: BACKGROUND

PMID: 39312891 (View on PubMed)

Other Identifiers

WBT-CI-D-2025

Identifier Type: -

Identifier Source: org_study_id