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

Not Applicable

Completed

• Conditions: Related Distress Among Cancer Caregivers; Insomnia

• Registration Number: NCT03012425
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-03
• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-01-04
• Study First Posted: 2017-01-06
• Primary Completion: 2020-10-23
• Study Completion: 2020-10-23
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-01
• Last Update Posted: 2021-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
number of participants who complete the assessments	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)

Trial Locations

Locations (3)

University of California, Irvine; 🇺🇸 Irvine, California, United States

Hunter College; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States