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Digital Cognitive Behavioral Therapy for Chronic Insomnia in Breast Cancer Survivors Using a Smartphone App A Randomized Controlled Study in China

Led by Peking University First Hospital · Updated on 2024-10-22

264

Participants Needed

1

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of a digital cognitive behavioral therapy for insomnia dCBT-I using a smartphone application called resleep for breast cancer survivors in China who have chronic insomnia. The study focuses on participants diagnosed with breast cancer within the last five years and currently experiencing chronic insomnia symptoms. The goal is to assess whether this digital self-help therapy can improve sleep quality compared to usual care without additional intervention. Participants are randomly assigned to one of two groups the dCBT-I treatment group or a wait-list control group. Those in the treatment group will use the smartphone app to complete a six-week full self-help cognitive behavioral therapy for insomnia. The wait-list group will continue their usual care without the digital therapy during the study period but may choose to receive the treatment after a three-month follow-up. The study compares sleep improvements immediately after treatment and at three months. Throughout the study, participants will complete assessments including the Insomnia Severity Index ISI at the end of treatment and after three months. Additional follow-ups will monitor ISI scores and online sleep diary data up to six months. Participants are expected to be comfortable using smartphone apps and filling out electronic questionnaires. The study tracks sleep improvements and monitors safety without masking or blinding. Total participation includes the therapy period and follow-up assessments over several months.

CONDITIONS

Brief Title

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

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