An interventional study of Prolonged exposure therapy in Posttraumatic Stress Disorders, Depression and Anxiety, sponsored by Veterans Medical Research Foundation. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-24.
Sponsored by Veterans Medical Research Foundation · Not applicable, Interventional, and Treatment
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 211 is above the median of 84 across 6,720 interventional studies indexed under Depression.
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Exclusion Criteria:
In this arm, veterans received standard psychotherapy (prolonged exposure therapy) in a novel format - interacting with a therapist via videoconferencing.
Behavioral: Prolonged exposure therapy
In this arm, veterans received standard psychotherapy (prolonged exposure therapy) in the traditional format - in person with a therapist.
Behavioral: Prolonged exposure therapy
Twelve sessions (90 minutes each) of prolonged exposure therapy
Clinician-administered PTSD Scale (CAPS) diagnostic interview
Measure of PTSD diagnosis and severity
Time frame: Pre-treatment, post-treatment (14 weeks after pre-treatment assessment), follow-up six months after post-treatment assessment
PHQ-9 (self-reported depression)
Measure of depressive symptoms
Time frame: Pre-treatment, weekly during 12 weeks of treatment, post-treatment (14 weeks after pre-treatment assessment), follow-up six months after post-treatment assessment
PTSD Checklist (PCL; self-reported PTSD symptoms)
Measure of 17 posttraumatic stress disorder (PTSD) symptoms from specific event (PCL-S)
Time frame: Pre-treatment, weekly during 12 weeks of treatment, post-treatment (14 weeks after pre-treatment assessment), follow-up six months after post-treatment assessment
Neuropsychological testing battery to assess cognitive functioning
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
Time frame: Pre-treatment and post-treatment (14 weeks after pre-treatment assessment)
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Veterans Medical Research Foundation