Pilot Study of Cognitive Behavioral Therapy for Insomnia (CBT-I) and Acupuncture for Insomnia and Related Distress Among Cancer Caregivers

Memorial Sloan Kettering Cancer Center3 sites in 1 country13 target enrollmentJanuary 3, 2017

ConditionsInsomnia Related Distress Among Cancer Caregivers

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Insomnia
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 13
Locations: 3
Primary Endpoint: number of participants who complete the assessments
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 3, 2017

End Date

October 23, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

number of participants who complete the assessments

Time Frame: 1 year

treatment tolerability (rate of CBT-I and acupuncture completion, defined as completing at least 4 out of 7 sessions of CBT-I and 8 out of 10 sessions of acupuncture)