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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Insomnia; Related Distress Among Cancer Caregivers

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03012425

17-001

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Experimental group

Description:

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.

Treatment:

Behavioral: questionnaires

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

Other: Diurnal Cortisol

Acupuncture

Experimental group

Description:

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.

Treatment:

Behavioral: questionnaires

Procedure: Acupuncture

Other: Diurnal Cortisol