Cognitive Behavioral Therapy for Trauma-Related Insomnia in Veterans
CBT-I Telemed
Comparing Telemedicine to In Person Delivery of Cognitive Behavioral Therapy for Trauma-Related Insomnia in Rural Veterans
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2010
CompletedFirst Posted
Study publicly available on registry
August 5, 2010
CompletedStudy Start
First participant enrolled
February 3, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 27, 2011
CompletedMarch 20, 2020
March 1, 2020
August 4, 2010
March 18, 2020
Conditions
Keywords
Study Arms (2)
CBT-I in person
ACTIVE COMPARATORCognitive behavioral therapy for insomnia delivered in person
CBT-I via telephone therapy
EXPERIMENTALCognitive behavioral therapy for insomnia delivered by telephone
Interventions
Cognitive Behavioral Therapy for Insomnia
Eligibility Criteria
You may qualify if:
- Veterans living 30 or more miles from VA PTSD specialty services
- Diagnosis of PTSD or subthreshold PTSD symptoms
- Trauma-related insomnia
You may not qualify if:
- Primary sleep disorder other than insomnia(e.g., Restless Leg Syndrome)
- Psychosis
- Active alcohol dependence
- Active drug dependence
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southeast Louisiana Veterans Health Care System
New Orleans, Louisiana, 70112, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurel Franklin, PhD
Southeast Louisiana Veterans Health Care System
- PRINCIPAL INVESTIGATOR
Sheila Corrigan, PhD
Southeast Louisiana Veterans Health Care System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Psychologist
Study Record Dates
First Submitted
August 4, 2010
First Posted
August 5, 2010
Study Start
February 3, 2011
Study Completion
September 27, 2011
Last Updated
March 20, 2020
Record last verified: 2020-03