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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
264
a full self-help digital cognitive behavioral therapy for Insomnia (dCBT-I) through a smartphone APP
Jing Ma
Beijing, Beijing Municipality, China
RECRUITINGThe insomnia severity index (ISI) scores
Time frame: immediately post-treatment
The insomnia severity index (ISI) scores
Time frame: 3-months follow-up
The insomnia severity index (ISI) scores
Time frame: 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)
Time frame: up to 6-months follow-up
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