Digital Cognitive Behavioral Therapy for Insomnia for Chronic Insomnia in Breast Cancer Survivors
NCT ID: NCT05813392
Last Updated: 2024-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
264 participants
INTERVENTIONAL
2023-08-29
2026-08-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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dCBT-I group
The dCBT-I group will receive full self-help dCBT-I through a smartphone APP for 6 weeks.
Digital Cognitive Behavioral Therapy for Insomnia
a full self-help digital cognitive behavioral therapy for Insomnia (dCBT-I) through a smartphone APP
the wait-list group
The wait-list group will not receive dCBT-I, waiting for treatment.At the end of the 3-month follow-up, the decision whether to receive treatment will be made according to the participants' wishes.
No interventions assigned to this group
Interventions
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Digital Cognitive Behavioral Therapy for Insomnia
a full self-help digital cognitive behavioral therapy for Insomnia (dCBT-I) through a smartphone APP
Eligibility Criteria
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Inclusion Criteria
2. Breast cancer diagnosed within 5 years
3. Stable disease at the end of acute treatment (surgery, radiotherapy, chemotherapy) while meeting: ≥ 1 month after surgery, ≥ 3 months after the end of last chemotherapy, and ≥ 3 months after the end of last radiotherapy if radiotherapy is required.
4. Satisfy the diagnostic criteria for chronic insomnia disorder according to the (International Classification of Sleep Disorders-the Third Edition, ICSD-3)\[ and Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5): problem with falling asleep or maintaining sleep for ≥3 months (≥3 times per week) with impaired daytime functioning, despite the availability of sleep opportunities.
5. ISI score ≥12.
6. Other sleep or psychiatric disorders, if present, must be stable and require no medication.
7. Be proficient in the use of a cell phone application, and be comfortable reading, filling out the electronic questionnaire, communicating, and fully understanding the content.
8. Sign the informed consent form. -
Exclusion Criteria
2. Expected survival \<12 months due to all causes
3. Presence of any of the following conditions: Concurrent active cancer or malignancy that is being treated other than breast cancer, shift work, alcohol abuse, substance abuse, significant suicidal ideation, bipolar disorder, aggressive behavior, mania, schizophrenia.
4. Presence of a diagnosed significant physical illness that interferes with sleep, such as cranial disease or trauma, cancer pain, unstable angina, uncontrolled cardiac insufficiency and severe respiratory distress due to various causes, etc.
5. Current or previous treatment with cognitive behavior therapy for insomnia (CBT-I).
6. Not signed informed consent.
18 Years
FEMALE
No
Sponsors
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Shenzhen Zeen Health Technology Co., Ltd.
UNKNOWN
Peking University First Hospital
OTHER
Responsible Party
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Jing MA
Pro.
Locations
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Jing Ma
Beijing, Beijing Municipality, China
Countries
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Facility Contacts
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Other Identifiers
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2022-376
Identifier Type: -
Identifier Source: org_study_id
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