NCT01158001

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

July 8, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

June 24, 2015

Status Verified

June 1, 2015

Enrollment Period

3.1 years

First QC Date

February 20, 2009

Last Update Submit

June 22, 2015

Conditions

Posttraumatic Stress DisordersDepressionAnxiety

Keywords

Posttraumatic stress disordersTelemedicinePsychotherapyNeuropsychological testDepression

Outcome Measures

Primary Outcomes (1)

  • Clinician-administered PTSD Scale (CAPS) diagnostic interview

    Measure of PTSD diagnosis and severity

    Pre-treatment, post-treatment (14 weeks after pre-treatment assessment), follow-up six months after post-treatment assessment

Secondary Outcomes (3)

  • 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 assessment

  • 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 assessment

  • Neuropsychological testing battery to assess cognitive functioning

    Pre-treatment and post-treatment (14 weeks after pre-treatment assessment)

Study Arms (2)

Psychotherapy via telemedicine

EXPERIMENTAL

In this arm, veterans received standard psychotherapy (prolonged exposure therapy) in a novel format - interacting with a therapist via videoconferencing.

Behavioral: Prolonged exposure therapy

Face-to-face (in person) psychotherapy

ACTIVE COMPARATOR

In this arm, veterans received standard psychotherapy (prolonged exposure therapy) in the traditional format - in person with a therapist.

Behavioral: Prolonged exposure therapy

Interventions

Prolonged exposure therapyBEHAVIORAL

Twelve sessions (90 minutes each) of prolonged exposure therapy

Face-to-face (in person) psychotherapyPsychotherapy via telemedicine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System

San Diego, California, 92108, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Steven R. Thorp, PhD

    Veterans Affairs San Diego Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2009

First Posted

July 8, 2010

Study Start

May 1, 2009

Primary Completion

June 1, 2012

Study Completion

September 1, 2012

Last Updated

June 24, 2015

Record last verified: 2015-06

Locations

US(1)