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DCBT-I for Sleep Disturbances in Cancer Pain Patients: A Online, Two-Arm, Single-Blind, Parallel-Group, Single-Center, Randomized Controlled Clinical Trial Protocol

DCBT-I for Sleep Disturbances in Cancer Pain Patients: A Online, Two-Arm, Single-Blind, Parallel-Group, Single-Center, Randomized Controlled Clinical Trial Protocol

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096855
Enrollment
Unknown
Registered
2025-02-07
Start date
2025-02-07
Completion date
Unknown
Last updated
2025-02-10

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

Conditions

Insomnia

Interventions

Intervention Group:Participants received a 6-week self-guided DCBT-I, an intervention delivered by a smartphone app called releep, which included sleep hygiene education, stimulus control, relaxation
Control Group:Receive 6 weeks of sleep hygiene education on the same app.

Sponsors

The Second Affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age >= 18 years; (2) Pathological diagnosis of malignant tumor; (3) Compliance with the diagnostic criteria for chronic insomnia of the International Classification of Sleep Disorders, Third Edition (ICSD-3); (4) PSQI (Pittsburgh Sleep Quality Index, Pittsburgh Sleep Quality Index) score >11; (5) Patients on prescription sleep medications who have been on the same medication and same dosage for at least 1 month and are not expected to change during the intervention phase; (6) Proficiency in the use of smartphone applications, ability to read the content of the electronic questionnaire and to fully understand and learn to complete it, and reliable Internet access; (7) Signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Have severe cognitive dysfunction or mental illness (e.g., significant suicidal ideation, bipolar disorder, aggressive behavior, manic or schizophrenic disorder, severe dementia, etc.); (2) Have apnea-sleep apnea syndrome, severe heart or lung disease; (3) Previously undergoing psychotherapy for insomnia or anticipating such treatment within the next 6 months; (4) Epworth Sleepiness Scale score >=12; and (5) Expected survival time < 6 months; (6) Did not sign an informed consent form.

Design outcomes

Secondary

MeasureTime frame
Sleep Diary;Pain intensity;Psychological health;Quality of life;

Primary

MeasureTime frame
Sleep quality;

Countries

China

Contacts

Public ContactRuilin He

The Second Affiliated Hospital of Guangxi Medical University

synf061@126.com+86 771 324 4390

Outcome results

None listed

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