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
• Interventions: Procedure: Acupuncture; Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I); Behavioral: questionnaires; Other: Diurnal Cortisol

• 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture	Diurnal Cortisol	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.
Cognitive Behavioral Therapy for Insomnia (CBT-I)	questionnaires	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.
Acupuncture	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.
Cognitive Behavioral Therapy for Insomnia (CBT-I)	Diurnal Cortisol	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.
Acupuncture	questionnaires	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.
Cognitive Behavioral Therapy for Insomnia (CBT-I)	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.

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)

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

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

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