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

Primary Purpose

Insomnia, Related Distress Among Cancer Caregivers

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Acupuncture
questionnaires
Diurnal Cortisol
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Cognitive Behavioral Therapy, Acupuncture, 17-001

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University of California, Irvine
  • Hunter College
  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Acupuncture

Arm 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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
January 4, 2017
Last Updated
November 1, 2021
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Hunter College of City University of New York
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1. Study Identification

Unique Protocol Identification Number
NCT03012425
Brief Title
Study of Cognitive Behavioral Therapy for Insomnia (CBT-I) and Acupuncture for Insomnia and Related Distress Among Cancer Caregivers
Official Title
Pilot Study of Cognitive Behavioral Therapy for Insomnia (CBT-I) and Acupuncture for Insomnia and Related Distress Among Cancer Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 3, 2017 (Actual)
Primary Completion Date
October 23, 2020 (Actual)
Study Completion Date
October 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Hunter College of City University of New York

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Related Distress Among Cancer Caregivers
Keywords
Cognitive Behavioral Therapy, Acupuncture, 17-001

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Arm Type
Experimental
Arm 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.
Arm Title
Acupuncture
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Type
Behavioral
Intervention Name(s)
questionnaires
Intervention Type
Other
Intervention Name(s)
Diurnal Cortisol
Intervention Description
saliva test
Primary Outcome Measure Information:
Title
number of participants who complete the assessments
Description
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)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison Applebaum, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Hunter College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

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

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