RecruitingNot ApplicableNCT05813392

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

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


Sponsor

Peking University First Hospital

Enrollment

264 participants

Start Date

Aug 29, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a digital version of Cognitive Behavioral Therapy for Insomnia (CBT-I) — a proven, non-medication sleep treatment — can help breast cancer survivors who are struggling with chronic insomnia after completing their main cancer treatment. **You may be eligible if...** - You are 18 or older and have been diagnosed with breast cancer within the last 5 years - You have finished active treatment (surgery, radiation, or chemotherapy) - At least 1 month has passed since your surgery, and at least 3 months since your last chemo or radiation - You have chronic insomnia (trouble sleeping most nights for at least 3 months) **You may NOT be eligible if...** - You are still receiving active cancer treatment - Your cancer is currently active or has spread - You do not have clinically diagnosed chronic insomnia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALDigital Cognitive Behavioral Therapy for Insomnia

a full self-help digital cognitive behavioral therapy for Insomnia (dCBT-I) through a smartphone APP


Locations(1)

Jing Ma

Beijing, Beijing Municipality, China

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NCT05813392


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