Clinical trial NCT06968013: Effect of WBT for CI With Depression
Official title: Investigating on the Efficacy of Well-Being Therapy (WBT) for Chronic Insomnia (CI) With Depressive Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Insomnia
Depression Disorders
Keywords: Chronic Insomnia
Depression Disorders
Well-Being Therapy
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 84
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at 6 Weeks
timeFrame: Baseline and Week 6
Secondary outcomes:
measure: Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Scores at 3, 6, and 12 Months
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Change from Baseline in Hamilton Depression Scale-17 (HAMD-17) Scores
timeFrame: Baseline, Week 6, 3 months, 6 months, and 12 months
measure: Change from Baseline in Beck Depression Inventory-II (BDI-II) Scores
timeFrame: Baseline, Week 6, 3 months, 6 months, and 12 months
measure: Change from Baseline in Beck Anxiety Inventory (BAI) Scores
timeFrame: Baseline, Week 6, 3 months, 6 months, and 12 months
measure: Change from Baseline in Patient Health Questionnaire-4 (PHQ-4) Scores
timeFrame: Baseline, Week 6, 3 months, 6 months, and 12 months
measure: Change from Baseline in 36-Item Short Form Health Survey (SF-36) Scores
timeFrame: Baseline, Week 6, 3 months, 6 months, and 12 months
measure: Change from Snaith-Hamilton Pleasure Scale (SHAPS) Scores
timeFrame: Baseline, Week 6, 3 months, 6 months, and 12 months
measure: Change from Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) Scores
timeFrame: Baseline, Week 6, 3 months, 6 months, and 12 months
measure: Change from Insomnia Severity Index (ISI) Scores
timeFrame: Baseline, Week 6, 3 months, 6 months, and 12 months
measure: Change in Self-rated Sleep Severity (0-10 Numeric Rating Scale)
timeFrame: Baseline, Week 6, 3 months, 6 months, and 12 months
measure: Frequency and Severity of Adverse Events
timeFrame: Throughout study duration up to 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
References:
citation: 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.