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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT03012425

Collaborator

Hunter College of City University of New York (Other)

Enrollment

Locations

Arms

45.6

Actual Duration (Months)

4.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia Related Distress Among Cancer Caregivers	Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I) Procedure: Acupuncture Behavioral: questionnaires Other: Diurnal Cortisol	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 3, 2017

Actual Primary Completion Date :

Oct 23, 2020

Actual Study Completion Date :

Oct 23, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I) Behavioral: questionnaires Other: Diurnal Cortisol saliva test
Experimental: 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.	Procedure: Acupuncture Behavioral: questionnaires Other: Diurnal Cortisol saliva test

Arm

Intervention/Treatment

Experimental: 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.

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

Behavioral: questionnaires

Other: Diurnal Cortisol

saliva test

Experimental: 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.

Procedure: Acupuncture

Behavioral: questionnaires

Other: Diurnal Cortisol

saliva test

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Irvine	Irvine	California	United States	92697
2	Hunter College	New York	New York	United States	10065
3	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065