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Trial Title:
Digital Cognitive Behavioral Therapy for Insomnia for Chronic Insomnia in Breast Cancer Survivors
NCT ID:
NCT05813392
Condition:
Chronic Insomnia
Conditions: Official terms:
Sleep Initiation and Maintenance Disorders
Conditions: Keywords:
Insomnia
Cognitive Behaviour Therapy for insomnia
breast cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
The enrolled breast cancer survivors were randomized into two groups: the intervention
group was the dCBT-I treatment group and the control group was the wait-for-treatment
group.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Digital Cognitive Behavioral Therapy for Insomnia
Description:
a full self-help digital cognitive behavioral therapy for Insomnia (dCBT-I) through a
smartphone APP
Arm group label:
dCBT-I group
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years.
2. Breast cancer diagnosed within 5 years
3. Stable disease at the end of acute treatment (surgery, radiotherapy, chemotherapy)
while meeting: ≥ 1 month after surgery, ≥ 3 months after the end of last
chemotherapy, and ≥ 3 months after the end of last radiotherapy if radiotherapy is
required.
4. Satisfy the diagnostic criteria for chronic insomnia disorder according to the
(International Classification of Sleep Disorders-the Third Edition, ICSD-3)[ and
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5):
problem with falling asleep or maintaining sleep for ≥3 months (≥3 times per week)
with impaired daytime functioning, despite the availability of sleep opportunities.
5. ISI score ≥12.
6. Other sleep or psychiatric disorders, if present, must be stable and require no
medication.
7. Be proficient in the use of a cell phone application, and be comfortable reading,
filling out the electronic questionnaire, communicating, and fully understanding the
content.
8. Sign the informed consent form. -
Exclusion Criteria:
1. New breast cancer progression, recurrence, or metastasis within 3 months, requiring
new radiotherapy or immunotherapy regimen
2. Expected survival <12 months due to all causes
3. Presence of any of the following conditions: Concurrent active cancer or malignancy
that is being treated other than breast cancer, shift work, alcohol abuse, substance
abuse, significant suicidal ideation, bipolar disorder, aggressive behavior, mania,
schizophrenia.
4. Presence of a diagnosed significant physical illness that interferes with sleep,
such as cranial disease or trauma, cancer pain, unstable angina, uncontrolled
cardiac insufficiency and severe respiratory distress due to various causes, etc.
5. Current or previous treatment with cognitive behavior therapy for insomnia (CBT-I).
6. Not signed informed consent.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Jing Ma
Address:
City:
Beijing
Zip:
100034
Country:
China
Status:
Recruiting
Contact:
Last name:
Jing Ma, Dr.
Phone:
+861013651357974
Email:
majjmail@163.com
Contact backup:
Last name:
Cheng Zhang, PhD
Email:
chengzhang@bjmu.edu.cn
Start date:
August 29, 2023
Completion date:
August 29, 2026
Lead sponsor:
Agency:
Peking University First Hospital
Agency class:
Other
Collaborator:
Agency:
Shenzhen Zeen Health Technology Co., Ltd.
Agency class:
Other
Source:
Peking University First Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05813392
