Cognitive Behavioral Therapy for Trauma-Related Insomnia in Veterans

NCT ID: NCT01176123

Last Updated: 2020-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-03

Study Completion Date

2011-09-27

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Initiation and Maintenance Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CBT-I in person

Cognitive behavioral therapy for insomnia delivered in person

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Therapy for Insomnia

Intervention Type BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia

CBT-I via telephone therapy

Cognitive behavioral therapy for insomnia delivered by telephone

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia

Intervention Type BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia

Interventions

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Cognitive Behavioral Therapy for Insomnia

Cognitive Behavioral Therapy for Insomnia

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VISN 16 Mental Illness Research, Education and Clinical Center (MIRECC)

UNKNOWN

Sponsor Role collaborator

Southeast Louisiana Veterans Health Care System

FED

Sponsor Role lead

Responsible Party

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C Laurel Franklin, PhD

Staff Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laurel Franklin, PhD

Role: PRINCIPAL_INVESTIGATOR

Southeast Louisiana Veterans Health Care System

Sheila Corrigan, PhD

Role: PRINCIPAL_INVESTIGATOR

Southeast Louisiana Veterans Health Care System

Locations

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Southeast Louisiana Veterans Health Care System

New Orleans, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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00366

Identifier Type: -

Identifier Source: org_study_id

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