Back to resultsCognitive Behavioral Therapy for Trauma-Related Insomnia in Veterans (CBT-I Telemed)
Primary Purpose
Sleep Initiation and Maintenance Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for Insomnia
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders focused on measuring Cognitive behavioral therapy, Insomnia, Traumatic Stress
Eligibility Criteria
Inclusion Criteria:
- Veterans living 30 or more miles from VA PTSD specialty services
- Diagnosis of PTSD or subthreshold PTSD symptoms
- Trauma-related insomnia
Exclusion Criteria:
- Primary sleep disorder other than insomnia(e.g., Restless Leg Syndrome)
- Psychosis
- Active alcohol dependence
- Active drug dependence
Sites / Locations
- Southeast Louisiana Veterans Health Care System
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CBT-I in person
CBT-I via telephone therapy
Arm Description
Cognitive behavioral therapy for insomnia delivered in person
Cognitive behavioral therapy for insomnia delivered by telephone
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01176123
First Posted
August 4, 2010
Last Updated
March 18, 2020
Sponsor
Southeast Louisiana Veterans Health Care System
Collaborators
VISN 16 Mental Illness Research, Education and Clinical Center (MIRECC)
1. Study Identification
Unique Protocol Identification Number
NCT01176123
Brief Title
Cognitive Behavioral Therapy for Trauma-Related Insomnia in Veterans
Acronym
CBT-I Telemed
Official Title
Comparing Telemedicine to In Person Delivery of Cognitive Behavioral Therapy for Trauma-Related Insomnia in Rural Veterans
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 3, 2011 (Actual)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 27, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast Louisiana Veterans Health Care System
Collaborators
VISN 16 Mental Illness Research, Education and Clinical Center (MIRECC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Understanding the effectiveness of Cognitive Behavioral Therapy for trauma-related insomnia (CBT-I) is important because sleep difficulties often persist after traditional post-trauma treatments are completed and other trauma-related symptoms have resolved. The objective of this study is to examine whether CBT-I will equivocally reduce problems falling and staying asleep (insomnia) related to military-related PTSD when administered in person versus through telephone therapy to veterans living in rural areas.
Rural populations are at a disadvantage in receiving treatment because of lack of access to healthcare services. Telemedicine uses technology (e.g., telephones) to provide distance counseling to the populations who lack access to health care. Thus, telephone-counseling strategies could provide broad access to interventions for management of trauma-related insomnia.
Veterans who live more than 30 miles from Veterans Affairs (VA) PTSD specialty services will be offered participation in this study. All veterans receive 6 weeks of individual CBT-I for trauma-related insomnia. Participants will be randomized to one of two treatment conditions: (1) CBT-I in person or (2) CBT-I via telemedicine (defined as receiving treatment by telephone). No changes will be made to the CBT-I, other than mode of delivery, for the telemedicine group.
Through this study the investigators hope to demonstrate the effectiveness of CBT-I for trauma-related insomnia can be delivered effectively to rural veterans in person and via telemedicine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders
Keywords
Cognitive behavioral therapy, Insomnia, Traumatic Stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT-I in person
Arm Type
Active Comparator
Arm Description
Cognitive behavioral therapy for insomnia delivered in person
Arm Title
CBT-I via telephone therapy
Arm Type
Experimental
Arm Description
Cognitive behavioral therapy for insomnia delivered by telephone
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia
Intervention Description
Cognitive Behavioral Therapy for Insomnia
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Veterans living 30 or more miles from VA PTSD specialty services
Diagnosis of PTSD or subthreshold PTSD symptoms
Trauma-related insomnia
Exclusion Criteria:
Primary sleep disorder other than insomnia(e.g., Restless Leg Syndrome)
Psychosis
Active alcohol dependence
Active drug dependence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurel Franklin, PhD
Organizational Affiliation
Southeast Louisiana Veterans Health Care System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sheila Corrigan, PhD
Organizational Affiliation
Southeast Louisiana Veterans Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southeast Louisiana Veterans Health Care System
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cognitive Behavioral Therapy for Trauma-Related Insomnia in Veterans
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