Digital therapy for insomnia in breast cancer survivors

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

This study is testing a digital therapy app to see if it can help breast cancer survivors with chronic insomnia sleep better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 264 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Peking University First Hospital (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05813392 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of a digital cognitive behavioral therapy (dCBT-I) app designed for chronic insomnia in breast cancer survivors. Participants will be randomly assigned to either the dCBT-I treatment group, which will use the app for six weeks, or a control group that will not receive additional interventions. The primary outcome will be measured using the insomnia severity index (ISI) after three months. The goal is to determine if this digital approach can significantly improve sleep quality in this population.

Who should consider this trial

Good fit: Ideal candidates are breast cancer survivors aged 18 and older who have been diagnosed within the last five years and are experiencing chronic insomnia.

Not a fit: Patients with unstable sleep or psychiatric disorders requiring medication may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could provide an accessible and effective treatment option for chronic insomnia in breast cancer survivors.

How similar studies have performed: Other studies have shown promising results with digital cognitive behavioral therapy for insomnia, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years.
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:

1. New breast cancer progression, recurrence, or metastasis within 3 months, requiring new radiotherapy or immunotherapy regimen
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.

Where this trial is running

Beijing, Beijing Municipality

• Jing Ma — Beijing, Beijing Municipality, China (RECRUITING)

Conditions: Chronic Insomnia, Insomnia, Cognitive Behaviour Therapy for insomnia, breast cancer