Clinical trial · Interventional
CBTI-CS: A Novel Cognitive-Behavioral Treatment for Insomnia in Cancer Survivors
NCT02756390CI-TRIAL-00036086completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research study is evaluating the effectiveness of a 3-session behavioral intervention for insomnia in cancer survivors. This is a behavioral intervention study, and no medications are involved.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CBTI-CS | Behavioral | — | UNRESOLVED |
| CBTI-CS via Telehealth | Behavioral | — | UNRESOLVED |
| Sleep Hygiene | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A (Sleep Hygiene & CBTI-CS)
- description
- Participants receive a single educational session describing principles of Sleep Hygiene for Cancer Survivors. Those who continue to have significant symptoms of insomnia then receive 3 groups CBTI-CS sessions
- interventionNames
- Behavioral: CBTI-CS
- Behavioral: Sleep Hygiene
- type
- OTHER
- label
- Arm B (Telehealth Pilot of CBTI-CS)
- description
- Descriptive data collected on 10 participants (non-randomized) receiving CBTI-CS via Telehealth.
- interventionNames
- Behavioral: CBTI-CS via Telehealth
Primary outcomes (1)
- measure
- The Insomnia Severity Index (ISI)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: -≥ 18 years of age * History of a cancer diagnosis * No active cancer therapy (excluding chemoprevention) in the past year, and no cancer therapy planned in the next 6 months * No surgery planned in the next 6 months * Significant insomnia as evidenced by an Insomnia Severity Index score ≥12 * Able to read and write in English * Willing to attend study group sessions * Motivated and able to follow the demands of the CBTI-CS program, to keep sleep records, complete self-report symptom reports and make changes in their sleep schedule, including restricting their sleep. Exclusion Criteria: * Survivors who report ever being diagnosed with Bipolar Disorder will be excluded. * Survivors who report ever being diagnosed with a Seizure Disorder or have experienced a seizure in the past 12 months will be excluded. * Intention to adjust (decrease or increase) use of sedative, hypnotic, or over-the-counter medications that can affect sleep during the study period. * Have diagnosed, untreated sleep apnea, or sleep apnea suspected by a physician but which has not been evaluated, or other sleep disorder * Employment that involves irregular sleep patterns, such as shift-work or frequent long-distance travel that involves adjusting to different time zones, or employment in a position that could impact public safety (such as operating heavy machinery) * Refusal to modify or reduce excessive alcohol use that is likely to interfere with an individual's sleep.
References
Publications (1)
- BACKGROUNDZhou ES, Partridge AH, Recklitis CJ. A pilot trial of brief group cognitive-behavioral treatment for insomnia in an adult cancer survivorship program. Psychooncology. 2017 Jun;26(6):843-848. doi: 10.1002/pon.4096. Epub 2016 Feb 12. PMID 26872123