Effect of WBT for CI With Depression

Capital Medical University

Status: Enrolling

Conditions: Chronic Insomnia; Depression Disorders

Treatments: Behavioral: Sleep Hygiene Education; Behavioral: Well-Being Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06968013

WBT-CI-D-2025

Details and patient eligibility

About

This randomized controlled trial aims to explore the therapeutic effects of Well-Being Therapy (WBT) on patients with Chronic Insomnia accompanied by depressive symptoms.

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

WBT-CI

Experimental group

Treatment:

Behavioral: Well-Being Therapy

SHE-CI

Active Comparator group

Treatment:

Behavioral: Sleep Hygiene Education