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

Overview

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.

Interventions

• Behavioral 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
• 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.

Primary outcome measures

• Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at 6 Weeks [Time frame: Baseline and Week 6]

Secondary outcome measures (11)

• Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Scores at 3, 6, and 12 Months [Time frame: Baseline, 3 months, 6 months, and 12 months]
• Change from Baseline in Hamilton Depression Scale-17 (HAMD-17) Scores [Time frame: Baseline, Week 6, 3 months, 6 months, and 12 months]
• Change from Baseline in Beck Depression Inventory-II (BDI-II) Scores [Time frame: Baseline, Week 6, 3 months, 6 months, and 12 months]
• Change from Baseline in Beck Anxiety Inventory (BAI) Scores [Time frame: Baseline, Week 6, 3 months, 6 months, and 12 months]
• Change from Baseline in Patient Health Questionnaire-4 (PHQ-4) Scores [Time frame: Baseline, Week 6, 3 months, 6 months, and 12 months]
• Change from Baseline in 36-Item Short Form Health Survey (SF-36) Scores [Time frame: Baseline, Week 6, 3 months, 6 months, and 12 months]
• Change from Snaith-Hamilton Pleasure Scale (SHAPS) Scores [Time frame: Baseline, Week 6, 3 months, 6 months, and 12 months]
• Change from Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) Scores [Time frame: Baseline, Week 6, 3 months, 6 months, and 12 months]
• Change from Insomnia Severity Index (ISI) Scores [Time frame: Baseline, Week 6, 3 months, 6 months, and 12 months]
• Change in Self-rated Sleep Severity (0-10 Numeric Rating Scale) [Time frame: Baseline, Week 6, 3 months, 6 months, and 12 months]
• Frequency and Severity of Adverse Events [Time frame: Throughout study duration up to 12 months]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Xuanwu Hospital, Capital Medical University — Beijing

Publications

• 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

Identifiers

NCT: NCT06968013 · WBT-CI-D-2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗