Skip to content

Study of the effectiveness of Brief Behavioural Therapy for Insomnia and related influencing factors

Study of the effectiveness of Brief Behavioural Therapy for Insomnia and related influencing factors

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113416
Enrollment
Unknown
Registered
2025-11-27
Start date
2022-06-20
Completion date
Unknown
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Interventions

Insomnia group:Brief Behavioral Treatment for Insomnia (BBTI), consisting of four sessions: two in-person face-to-face sessions lasting 45–60 minutes each, and two brief online sessions lasting 15–30
Healthy Control Group:No intervention measures were implemented
only a cross-sectional comparison with the insomnia group was conducted.

Sponsors

The First Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Insomnia Patient Group: (1) Meet the diagnostic criteria for Insomnia Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5): 1) The patient reports dissatisfaction with sleep quality or sleep duration, manifesting as: difficulty initiating sleep, early morning awakening, or difficulty maintaining sleep (frequent nocturnal awakenings or inability to return to sleep after awakening); 2) The insomnia causes significant clinical distress or impairment in social, occupational, educational, or other important areas of functioning; 3) The above symptoms occur at a frequency of >3 times per week; 4) The above symptoms persist for a duration of >=3 months; 5) The patient has adequate opportunity and a favorable environment for sleep; 6) The patient reports at least one daytime consequence related to poor sleep (e.g., fatigue, impaired cognitive or emotional functioning); 7) The above symptoms cannot be better explained by another sleep-wake disorder (e.g., narcolepsy, sleep-disordered breathing, circadian rhythm sleep-wake disorder, parasomnias); 8) The above symptoms are not attributable to the physiological effects of drugs, substance abuse, or other substances; 9) The insomnia symptoms are not secondary to another medical or psychiatric condition. (2) No restriction on gender; age 18–80 years; (3) No significant psychosocial stressors; no severe life or psychological events affecting sleep within the recent period (except sleep-related fear). 2. Healthy Control Group: (1) Matched with the insomnia patient group in terms of demographic characteristics such as gender, age, and education level; (2) Hamilton Anxiety Scale (HAMA) score <7, Hamilton Depression Scale (HAMD) score <7, Insomnia Severity Index (ISI) score <8; (3) No intake of alcohol, caffeine, or other psychoactive substances within 24 hours prior to assessment; (4) Voluntarily participate in this study and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Exclusion Criteria for the Insomnia Patient Group: (1) Presence of a diagnosed physical illness known to cause insomnia; (2) Presence of other psychiatric disorders (e.g., severe anxiety, major depression, mania, bipolar disorder, or schizophrenia) that impair treatment compliance; (3) History of receiving cognitive behavioral therapy or related psychological interventions for insomnia; (4) History of substance abuse involving alcohol, drugs, excessive caffeine, or other psychoactive substances; (5) Pregnancy or lactation; (6) Illiteracy or inability to comprehend study materials; (7) Shift workers. 2. Exclusion Criteria for the Healthy Control Group: (1) Personal history of psychiatric disorder or family history of psychiatric illness; (2) Presence of serious physical illnesses (e.g., coronary heart disease, thyroid disease, malignancy); (3) Brain injury due to any cause (e.g., traumatic brain injury, stroke, Parkinson’s disease, dementia, or epilepsy); (4) History of substance abuse involving alcohol, drugs, excessive caffeine, or other psychoactive substances.

Design outcomes

Primary

MeasureTime frame
Insomnia severity;

Secondary

MeasureTime frame
Sleep conditions;Depression;Anxiety;Hyperarousal traits;Beliefs and attitudes about sleep;Heart Rate;Sleep quality ;Daytime sleepiness;Heart Rate Variability;Skin Conductance Level;Internal perception;

Countries

China

Contacts

Public ContactChang Yi

The First Hospital of Dalian Medical University

changee99@gmail.com+86 180 9887 6237

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026