Cognitive behavioural therapy for insomnia in people with cancer.
Zhaolun Cai, Yiguo Tang, Chunyu Liu...
https://pubmed.ncbi.nlm.nih.gov/41170811/Actively Recruiting
Led by Peking University First Hospital · Updated on 2024-10-22
264
Participants Needed
1
Research Sites
52 weeks
Total Duration
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
Digital Cognitive Behavioral Therapy for Insomnia for Chronic Insomnia in Breast Cancer Survivors
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Peking University First Hospital
Lead Sponsor
Shenzhen Zeen Health Technology Co., Ltd.
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - 6 weeks
Participants in the treatment group complete a full self-help digital cognitive behavioral therapy for insomnia (dCBT-I) through a smartphone app.
Weekly app-based sessions
Duration - Up to 6 months
Participants are monitored for insomnia severity and sleep patterns after completing the treatment or wait-list period.
Assessments immediately post-treatment, at 3 months, and at 6 months; online sleep diary entries during follow-up
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Zhaolun Cai, Yiguo Tang, Chunyu Liu...
https://pubmed.ncbi.nlm.nih.gov/41170811/Peking University First Hospital
Lead Sponsor
Shenzhen Zeen Health Technology Co., Ltd.
Collaborating Sponsor