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CBT-I Telemed: Cognitive Behavioral Therapy for Trauma-Related Insomnia in Veterans

Sponsor
Southeast Louisiana Veterans Health Care System (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT01176123
Collaborator
VISN 16 Mental Illness Research, Education and Clinical Center (MIRECC) (Other)
24
Enrollment
1
Location
2
Arms
7.8
Actual Duration (Months)
3.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive Behavioral Therapy for Insomnia
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparing Telemedicine to In Person Delivery of Cognitive Behavioral Therapy for Trauma-Related Insomnia in Rural Veterans
Actual Study Start Date :
Feb 3, 2011
Actual Study Completion Date :
Sep 27, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: CBT-I in person

Cognitive behavioral therapy for insomnia delivered in person

Behavioral: Cognitive Behavioral Therapy for Insomnia
Cognitive Behavioral Therapy for Insomnia
Experimental: CBT-I via telephone therapy

Cognitive behavioral therapy for insomnia delivered by telephone

Behavioral: Cognitive Behavioral Therapy for Insomnia
Cognitive Behavioral Therapy for Insomnia

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Southeast Louisiana Veterans Health Care System New Orleans Louisiana United States 70112

    Sponsors and Collaborators

    • Southeast Louisiana Veterans Health Care System
    • VISN 16 Mental Illness Research, Education and Clinical Center (MIRECC)

    Investigators

    • Principal Investigator: Laurel Franklin, PhD, Southeast Louisiana Veterans Health Care System
    • Principal Investigator: Sheila Corrigan, PhD, Southeast Louisiana Veterans Health Care System

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    C Laurel Franklin, PhD, Staff Psychologist, Southeast Louisiana Veterans Health Care System
    ClinicalTrials.gov Identifier:
    NCT01176123
    Other Study ID Numbers:
    • 00366
    First Posted:
    Aug 5, 2010
    Last Update Posted:
    Mar 20, 2020
    Last Verified:
    Mar 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by C Laurel Franklin, PhD, Staff Psychologist, Southeast Louisiana Veterans Health Care System
    Cognitive behavioral therapy
    Insomnia
    Traumatic Stress
    Additional relevant MeSH terms:
    Sleep Initiation and Maintenance Disorders

    Study Results

    No Results Posted as of Mar 20, 2020