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NCT03012425 Clinical Trial

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

Insomnia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03012425
Other study ID # 17-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 3, 2017
Est. completion date October 23, 2020

Study information
Verified date November 2021
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 13
Est. completion date October 23, 2020
Est. primary completion date October 23, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

  • Insomnia
  • Related Distress Among Cancer Caregivers
  • Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive Behavioral Therapy for Insomnia (CBT-I)

Procedure:
• Acupuncture

Behavioral:
• questionnaires

Other:
• Diurnal Cortisol
saliva test

Locations
Country Name City State
United States 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

Sponsors (2)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center Hunter College of City University of New York

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of participants who complete the assessments 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) 1 year
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