Clinical trial · Interventional
Study of Cognitive Behavioral Therapy for Insomnia (CBT-I) and Acupuncture for Insomnia and Related Distress Among Cancer Caregivers
Pilot Study of Cognitive Behavioral Therapy for Insomnia (CBT-I) and Acupuncture for Insomnia and Related Distress Among Cancer Caregivers
NCT03012425CI-TRIAL-00054928completedN/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)
The other aim of this study is to determine which of those two treatments (acupuncture or cognitive behavioral therapy) works better for treating insomnia in Informal Caregivers of cancer patients.
Conditions
Conditions (2)
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 | — |
| Related Distress Among Cancer Caregivers | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acupuncture | Procedure | — | UNRESOLVED |
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | Behavioral | — | UNRESOLVED |
| Diurnal Cortisol | Other | — | UNRESOLVED |
| questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cognitive Behavioral Therapy for Insomnia (CBT-I)
- description
- Session 1- Review of initial sleep diary, formulation of impression of type/subtype of insomnia, determine modifiable factors, address immediate concerns about participation, discuss motivation \& compliance. Session 2- Review of sleep diary, present 4-P model of insomnia, prescribe Sleep Restriction \& Stimulus Control Therapy. Session 3- Review of sleep diary, continue with stimulus control \& sleep restriction procedures, review of sleep hygiene. Session 4- Review of sleep diary, continue with stimulus control \& sleep restriction procedures, introduce \& practice relaxation strategies. Session 5- Review of sleep diary, continue with stimulus control \& sleep restriction procedures, conduct cognitive therapy to address dysfunctional thoughts underlying insomnia. Session 6- Review of sleep diary, continue with stimulus control \& sleep restriction procedures Session 7- Review of sleep diary \& overall progress, discuss relapse prevention, further sleep restriction guidelines \& prophylaxis.
- interventionNames
- Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
- Behavioral: questionnaires
- Other: Diurnal Cortisol
- type
- EXPERIMENTAL
- label
- Acupuncture
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * As per self report, age 18 and older * As per self report, identifying as an informal caregiver to MSKCC patients of any site or stage of cancer * Score greater than 7 on the Insomnia Severity Index and meet the criteria for Insomnia Disorder as defined by the Diagnostic and Statistical Manual of Mental disorders, 5th Edition (DSM-5) (56) as assessed by the Insomnia Interview Schedule * In the judgment of the investigators and/or consenting professional, able to read and comprehend English * In the judgment of the consenting professional cognitively able to provide informed consent Exclusion Criteria: * As per self report, participant has another sleep disorder provided that it is not adequately treated (e.g., sleep apnea without CPAP treatment) * As per self report, participant has major depressive disorder, alcohol or drug dependence and * As per self report, heavy drinker (regularly having more than 14 alcoholic beverages per week) * As per self report, engaging in night shift work * To not obscure cortisol assessment, regular smokers per self report (daily use) will be excluded. * As per self report significant needle phobia as to prevent participation in acupuncture
References
Publications (0)
Data not yet available
No reference posted for this study.