Clinical trial · Interventional
Web-based Insomnia Treatment for Adolescent and Young Adult Cancer Survivors
NCT03279055CI-TRIAL-00047949completedN/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 a six-session online program designed to help insomnia (difficulty falling or staying asleep) in adolescent and young adult cancer survivors.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHUTi | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHUTi
- description
- * Participants will be provided with an individual access code for SHUTi * SHUTi is delivered over 6 sessions, each taking 20-30 minutes * SHUTi is delivered by a virtual therapist * Participants will learn about the etiology and maintenance of their insomnia * Participants will learn how to maintain their sleep log * Participants will learn how to address lifestyle barriers that impact their sleep * Participants will be taught stimulus control techniques targeting non-sleep behaviors in the bedroom * Participants will learn a range of cognitive techniques that address the key cognitive factors that perpetuate poor sleep behavior * Participants will be taught how to gradually expand their restricted sleep
- interventionNames
- Behavioral: SHUTi
Primary outcomes (1)
- measure
- Insomnia symptoms
- timeFrame
- 8 weeks
- description
- Insomnia symptom severity will be assessed using the Insomnia Severity Index
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * 14-25 years of age * History of a cancer diagnosis * No active cancer therapy (excluding chemoprevention) in the past three months, and no cancer therapy currently 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 * Has internet access at home * Motivated and able to follow the demands of the SHUTi program, to keep sleep records, complete self-report symptom reports and make changes in their sleep schedule, including restricting their sleep Exclusion Criteria: * Prior attempt(s) to treat insomnia using cognitive-behavioral treatment for insomnia * History of Bipolar Disorder diagnosis * History of a Seizure Disorder diagnosis or have experienced a seizure in the past 12 months * Intention to adjust (decrease or increase) use of sedative, hypnotic, or over-the-counter (e.g., Benadryl, Unisom) medications that can affect sleep during the study period * Diagnosed, untreated sleep apnea or sleep apnea suspected by a physician but which has not been unevaluated, 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)
- RESULTZhou ES, Recklitis CJ. Internet-delivered insomnia intervention improves sleep and quality of life for adolescent and young adult cancer survivors. Pediatr Blood Cancer. 2020 Sep;67(9):e28506. doi: 10.1002/pbc.28506. Epub 2020 Jun 22. PMID 32568460