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

Study Overview
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Brief Summary
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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.

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

Conditions
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Insomnia, Related Distress Among Cancer Caregivers

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
* Procedure: Acupuncture
* Behavioral: questionnaires
* Other: Diurnal Cortisol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Therapy for Insomnia (CBT-I)<br>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. | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)<br> <br> Behavioral: questionnaires<br> <br> Other: Diurnal Cortisol<br>* saliva test<br>|
| Experimental: Acupuncture<br>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. | Procedure: Acupuncture<br> <br> Behavioral: questionnaires<br> <br> Other: Diurnal Cortisol<br>* saliva test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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17-001, Cognitive Behavioral Therapy, Acupuncture