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A study of the efficacy of Brief Behavioral Therapy for Insomnia Integrating Motivational Interviewing (BBTI-MI) in the treatment of treatment-resistant insomnia

A study of the efficacy of Brief Behavioral Therapy for Insomnia Integrating Motivational Interviewing (BBTI-MI) in the treatment of treatment-resistant insomnia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112564
Enrollment
Unknown
Registered
2025-11-17
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

Drug-refractory insomnia

Interventions

Control group:Brief Behavioral Therapy for Insomnia
Experimental group:Integrating Motivational Interviewing for Brief Behavioral Therapy for Insomnia

Sponsors

The First Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age range: 18 - 60 years old, gender not restricted; 2. Meets the diagnostic criteria for insomnia as defined in the 5th Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V): (1) The patient complains of dissatisfaction with sleep quality or duration, with symptoms including: inability to fall asleep, early awakening, difficulty maintaining stable sleep (frequent awakenings at night, difficulty falling back asleep after waking up); (2) Insomnia disorder has led to obvious clinical symptoms or impaired social, occupational, educational, or behavioral functions; (3) The above symptoms occur more than 3 times per week; (4) The above symptoms have persisted for at least 3 months; (5) There is sufficient sleep opportunity and a good sleep environment; (6) The patient complains of at least one negative impact during the day (such as fatigue, impaired function, or emotional disorder), which can be attributed to poor sleep; (7) The above symptoms cannot be explained by other sleep-wake disorders (such as narcolepsy, respiratory-related sleep disorders, circadian rhythm sleep disorders, parasomnia); (8) The above symptoms are not caused by physiological effects of drugs or substances (such as drug abuse); (9) Insomnia symptoms are not secondary to physical or mental disorders; 3. Has used sedative-hypnotic drugs at least once a day in the past 3 months, but is still dissatisfied with the current sleep situation; 4. Can read and understand Chinese, and be able to use electronic devices; 5. Has no obvious psychological stress events, and there have been no serious sleep-disrupting life or psychological events in the recent period (except for sleep phobia); 6. Agrees to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Currently suffering from bipolar disorder, schizophrenia, post-traumatic stress disorder and other mental disorders that affect sleep; 2. Severe mental disability or physical illness; 3.Pregnant or lactating women; 4.A history of epilepsy or any brain injury; 5.Currently engaged in time-zone, night shift or shift work; 6.Having received cognitive behavior-related treatment for insomnia in the past; 7.Other unsuitable for inclusion in the study.

Design outcomes

Secondary

MeasureTime frame
Degree of sleepiness;Anxiety;The situation of sleep in night;Depression;Sleep quality;Motivation;

Primary

MeasureTime frame
Severity of insomnia;

Countries

China

Contacts

Public ContactYi Chang

The First Affiliated Hospital of Dalian Medical University

changee99@163.com+86 411 83635963

Outcome results

None listed

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