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NCT05813392
Digital Cognitive Behavioral Therapy for Insomnia for Chronic Insomnia in Breast Cancer Survivors
NA trial testing Digital Cognitive Behavioral Therapy for Insomnia in Chronic Insomnia in 264 participants. Currently enrolling.
29 August 2025
Quick facts
| Lead sponsor | Peking University First Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 264 |
| Start date | 29 August 2023 |
| Primary completion | 29 August 2025 |
| Estimated completion | 29 August 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Digital Cognitive Behavioral Therapy for Insomnia
Conditions studied
- Chronic Insomnia — all drugs for Chronic Insomnia →
Sponsor
Peking University First Hospital
Who can join
18 and older, female only, with Chronic Insomnia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05813392
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Related trials
Other trials of Digital Cognitive Behavioral Therapy for Insomnia
Trials testing the same drug.
- NCT04986007 — Addressing Nocturnal Sleep/Wake Effects on Risk of Suicide in Older Adults · NA · terminated
Other recruiting trials for Chronic Insomnia
Currently open trials in the same condition.
- NCT06251258 — Facial Emotion Recognition in Insomnia and Emotional Regulation · NA · recruiting
- NCT06898099 — Evaluation of the Efficacy of E2R Hypnotherapy in the Management of Chronic Insomnia in Primary Care (HypERR) · NA · recruiting
- NCT06983275 — Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms · NA · recruiting
- NCT07429578 — Transcranial Alternating Current Stimulation for Generalized Anxiety Disorder and Insomnia: An Open-Label Pilot Study · NA · recruiting
- NCT06658158 — Effects of Cognitive Correction and Stimulus Control in Chronic Insomnia Patients · NA · recruiting
Other Peking University First Hospital trials
Trials by the same sponsor.
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- NCT07517276 — TUDCA in High-Risk Lactating Mothers Identified by Early Postpartum Milk Hydrophobicity Index · Phase 2 · not yet recruiting
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- NCT07464119 — A Clinical Study of iPSC-Derived Islet Cells for Diabetes Mellitus Therapy · NA · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05813392 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Peking University First Hospital
- Last refreshed: 22 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05813392.
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