Actively Recruiting
Digital Cognitive Behavioral Therapy for Insomnia for Chronic Insomnia in Breast Cancer Survivors
Led by Peking University First Hospital · Updated on 2024-10-22
264
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
P
Peking University First Hospital
Lead Sponsor
S
Shenzhen Zeen Health Technology Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Digital Cognitive Behavioral Therapy for Insomnia for Chronic Insomnia in Breast Cancer Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Breast cancer diagnosed within 5 years
- Stable disease after acute treatment: at least 1 month after surgery, 3 months after last chemotherapy, and 3 months after last radiotherapy if given
- Meets chronic insomnia disorder criteria with sleep problems lasting 3 months or more, occurring 3 or more times per week, with daytime impairment
- Insomnia Severity Index (ISI) score of 12 or higher
- Other sleep or psychiatric disorders must be stable and require no medication
- Proficient in using a smartphone app and able to understand and complete electronic questionnaires
- Signed informed consent form
You will not qualify if you...
- New breast cancer progression, recurrence, or metastasis within 3 months requiring new radiotherapy or immunotherapy
- Expected survival less than 12 months
- Active cancer or malignancy other than breast cancer under treatment
- Shift work
- Alcohol or substance abuse
- Significant suicidal ideation, bipolar disorder, aggressive behavior, mania, or schizophrenia
- Diagnosed significant physical illness interfering with sleep such as cranial disease, cancer pain, unstable angina, uncontrolled heart failure, or severe respiratory distress
- Current or previous cognitive behavioral therapy for insomnia (CBT-I)
- Did not sign informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Jing Ma
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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