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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01158001
Enrollment
211
Registered
2010-07-08
Start date
2009-05-31
Completion date
2012-09-30
Last updated
2015-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Posttraumatic Stress Disorders

Keywords

Posttraumatic stress disorders, Telemedicine, Psychotherapy, Neuropsychological test, Depression

Brief summary

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.

Detailed 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.

Interventions

BEHAVIORALProlonged exposure therapy

Twelve sessions (90 minutes each) of prolonged exposure therapy

Sponsors

United States Department of Defense
CollaboratorFED
University of Pennsylvania
CollaboratorOTHER
Veterans Medical Research Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinician-administered PTSD Scale (CAPS) diagnostic interviewPre-treatment, post-treatment (14 weeks after pre-treatment assessment), follow-up six months after post-treatment assessmentMeasure of PTSD diagnosis and severity

Secondary

MeasureTime frameDescription
PHQ-9 (self-reported depression)Pre-treatment, weekly during 12 weeks of treatment, post-treatment (14 weeks after pre-treatment assessment), follow-up six months after post-treatment assessmentMeasure of depressive symptoms
PTSD Checklist (PCL; self-reported PTSD symptoms)Pre-treatment, weekly during 12 weeks of treatment, post-treatment (14 weeks after pre-treatment assessment), follow-up six months after post-treatment assessmentMeasure of 17 posttraumatic stress disorder (PTSD) symptoms from specific event (PCL-S)
Neuropsychological testing battery to assess cognitive functioningPre-treatment and post-treatment (14 weeks after pre-treatment assessment)1. Wechsler Test of Adult Reading 2. Rey Complex Figure task 3. California Verbal Learning Test 4. Wisconsin Card Sort Test 5. Wechsler Adult Intelligence Scale Digit Span 6. Delis-Kaplan Executive Functioning System (D-KEFS) Verbal Fluency 7. Delis-Kaplan Executive Functioning System (D-KEFS) Color-Word Interference 8. Delis-Kaplan Executive Functioning System (D-KEFS) Trails

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026