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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Southeast Louisiana Veterans Health Care System.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
VISN 16 Mental Illness, Research, Education adn Clinical Center (MIRECC)
Information provided by:
Southeast Louisiana Veterans Health Care System
ClinicalTrials.gov Identifier:
NCT01176123
First received: August 4, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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 Intervention
Sleep Initiation and Maintenance Disorders
Behavioral: Cognitive Behavioral Therapy for Insomnia

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Comparing Telemedicine to In Person Delivery of Cognitive Behavioral Therapy for Trauma-Related Insomnia in Rural Veterans

Resource links provided by NLM:


Further study details as provided by Southeast Louisiana Veterans Health Care System:

Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01176123

Contacts
Contact: Laurel Franklin, PhD 504-571-8294 laurel.franklin@va.gov
Contact: Sheila Corrigan, PhD 985-690-6907 sheila.corrigan@va.gov

Locations
United States, Louisiana
Southeast Louisiana Veterans Health Care System Not yet recruiting
New Orleans, Louisiana, United States, 70112
Contact: Laurel Franklin, PhD    504-571-8294    laurel.franklin@va.gov   
Contact: Sheila Corrigan, PhD    985-690-6907    sheila.corrigan@va.gov   
Principal Investigator: Laurel Franklin, PhD         
Sub-Investigator: Sheila Corrigan, PhD         
Sponsors and Collaborators
VISN 16 Mental Illness, Research, Education adn 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
  More Information

No publications provided

Responsible Party: C. Laurel Franklin, Ph.D., Southeast Louisiana Veterans Health Care System
ClinicalTrials.gov Identifier: NCT01176123     History of Changes
Other Study ID Numbers: 00366
Study First Received: August 4, 2010
Last Updated: August 4, 2010
Health Authority: United States: Federal Government

Keywords provided by Southeast Louisiana Veterans Health Care System:
Cognitive behavioral therapy
Insomnia
Traumatic Stress

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014