Digital Cognitive Behavioral Therapy for Insomnia for Chronic Insomnia in Breast Cancer Survivors

Study Overview
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Brief Summary
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To explore the efficacy of dCBT-I therapy for chronic insomnia among breast cancer survivors in China, we propose to conduct a randomized, parallel controlled clinical study in breast cancer survivors using a smartphone Chinese application (app) resleep. Breast cancer survivors with chronic insomnia were recruited from our Breast Disease Center and externally, with the waiting group as a parallel control and the dCBT-I treatment group as an intervention group, in a 1:1 sample size. Intervention group (dCBT-I treatment group) will receive full self-help dCBT-I administered by smartphone APP for 6 weeks. The control group (waiting for treatment group) will not receive any additional interventions based on the original conventional treatment and will be followed up as planned, waiting for treatment.At the end of the 3-month follow-up, the decision to receive treatment was made according to the patient's wishes. The primary endpoint was the insomnia severity index (ISI) at the end of treatment and at 3 months of treatment.

Official Title
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Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) for Chronic Insomnia in Breast Cancer Survivors, A Randomized Controlled Trial

Conditions
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Chronic Insomnia

Intervention / Treatment
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* Behavioral: Digital Cognitive Behavioral Therapy for Insomnia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years. Breast cancer diagnosed within 5 years 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. 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. ISI score ≥12. Other sleep or psychiatric disorders, if present, must be stable and require no medication. 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. Sign the informed consent form. - Exclusion Criteria: New breast cancer progression, recurrence, or metastasis within 3 months, requiring new radiotherapy or immunotherapy regimen Expected survival <12 months due to all causes 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. 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. Current or previous treatment with cognitive behavior therapy for insomnia (CBT-I). Not signed informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The enrolled breast cancer survivors were randomized into two groups: the intervention group was the dCBT-I treatment group and the control group was the wait-for-treatment group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dCBT-I group<br>The dCBT-I group will receive full self-help dCBT-I through a smartphone APP for 6 weeks. | Behavioral: Digital Cognitive Behavioral Therapy for Insomnia<br>* a full self-help digital cognitive behavioral therapy for Insomnia (dCBT-I) through a smartphone APP<br>|
| No Intervention: the wait-list group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The insomnia severity index (ISI) scores |  | immediately post-treatment | 
| The insomnia severity index (ISI) scores |  | 3-months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The insomnia severity index (ISI) scores |  | 6-months follow-up | 
| Online sleep diary measures | Online sleep diary measures（total sleep time, sleep efficiency, sleep latency, numbers and duration of awakenings during sleep) | up to 6-months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Cognitive Behaviour Therapy for insomnia, breast cancer