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Telemedicine for Improved Delivery of Psychosocial Treatments for Post Traumatic Stress Disorder

V

Veterans Medical Research Foundation

Status

Completed

Conditions

Depression
Anxiety
Posttraumatic Stress Disorders

Treatments

Behavioral: Prolonged exposure therapy

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01158001
080513
PT074431

Details and patient eligibility

About

The objective of the proposed study is to conduct a systematic comparison of post traumatic stress disorder (PTSD) outcomes for veterans receiving exposure therapy via telemedicine versus in-person care. The primary aim is to determine feasibility: whether telemedicine can be used as a tool to extend effective, specialized mental health services, such as Prolonged Exposure therapy (PE; a therapy designed to help clients face fears related to a traumatic event), to veterans with limited access to care. A secondary aim is to determine if therapy delivered by telemedicine affects the quality of care in terms of clinical outcomes and the quality of patient-therapist interaction. A tertiary aim is to examine whether results from neuropsychological testing predict treatment outcomes.

Full description

The objective of the proposed study is to conduct a systematic comparison of post traumatic stress disorder (PTSD) outcomes for veterans receiving exposure therapy via telemedicine versus in-person care. Specifically, prolonged exposure therapy (PE) was conducted with veterans individually, either in person or via videoconferencing technology. PE is designed to help clients face fears related to a traumatic experience by guiding individuals through exposures to the memory of the event (called "imaginal exposure") and exposures to feared situations (called "in vivo" exposures).

The primary aim is to determine the feasibility of whether telemedicine can be used as a tool to extend effective, specialized mental health services, such as PE to veterans with limited access to care. This is measured in part through patient and therapist satisfaction ratings in each condition.

A secondary aim is to determine if therapy delivered by telemedicine affects the quality of care in terms of clinical outcomes and the quality of patient-therapist interaction. This is measured by relative changes in symptoms, primarily in PTSD, depressive symptoms, and anxiety symptoms.

A tertiary aim is to examine whether results from neuropsychological testing predict treatment outcomes across conditions. This includes seven measures of executive functioning. The hypothesis is that poorer performance on these measures may be associated with less improvement on measures of symptom severity.

Enrollment

211 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Primary diagnosis of chronic PTSD due to combat; comorbid mood and anxiety disorders are expected, and will be permitted (to maximize generalizability) if PTSD symptoms are judged to be predominant based on primacy and severity of symptoms
  • Age 18 or older
  • English literacy

Exclusion criteria

  • Unmanaged psychosis or manic episodes in past year
  • Concurrent psychotherapies targeting PTSD or depression or that entail exposure therapy [veterans who are engaged in treatment for non-PTSD symptoms (e.g., 12-step programs for substance problems) will be eligible]
  • Severe cardiovascular or respiratory disease that would make it difficult to ensure regular attendance at psychotherapy sessions
  • Probable dementia; OR
  • Head trauma resulting in loss of consciousness longer than 20 minutes. Potential participants who have had changes in the type and dosage of psychotropic medications in the preceding two months will be asked to wait until their medication regimen has stabilized to minimize treatment confounds.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

211 participants in 2 patient groups

Psychotherapy via telemedicine
Experimental group
Description:
In this arm, veterans received standard psychotherapy (prolonged exposure therapy) in a novel format - interacting with a therapist via videoconferencing.
Treatment:
Behavioral: Prolonged exposure therapy
Face-to-face (in person) psychotherapy
Active Comparator group
Description:
In this arm, veterans received standard psychotherapy (prolonged exposure therapy) in the traditional format - in person with a therapist.
Treatment:
Behavioral: Prolonged exposure therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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