Study of Cognitive Behavioral Therapy for Insomnia (CBT-I) and Acupuncture for Insomnia and Related Distress Among Cancer Caregivers
NCT ID: NCT03012425
Last Updated: 2021-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
13 participants
INTERVENTIONAL
2017-01-03
2020-10-23
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cognitive Behavioral Therapy for Insomnia (CBT-I)
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.
Cognitive Behavioral Therapy for Insomnia (CBT-I)
questionnaires
Diurnal Cortisol
saliva test
Acupuncture
Session 1 - Detailed history and examination, introduction to acupuncture. Sessions 2 - 10 - Each session will begin with insertion and manipulation of needles, which will remain in place for 30 minutes.
Acupuncture
questionnaires
Diurnal Cortisol
saliva test
Interventions
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Cognitive Behavioral Therapy for Insomnia (CBT-I)
Acupuncture
questionnaires
Diurnal Cortisol
saliva test
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
Yes
Sponsors
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Hunter College of City University of New York
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Allison Applebaum, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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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
Countries
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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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17-001
Identifier Type: -
Identifier Source: org_study_id