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

NCT ID: NCT01158001

Last Updated: 2015-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 211 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2012-09-30

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.

Conditions

Posttraumatic Stress Disorders; Depression; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Psychotherapy via telemedicine

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

Group Type: EXPERIMENTAL

Prolonged exposure therapy

Intervention Type: BEHAVIORAL

Twelve sessions (90 minutes each) of prolonged exposure therapy

Face-to-face (in person) psychotherapy

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

Group Type: ACTIVE_COMPARATOR

Prolonged exposure therapy

Intervention Type: BEHAVIORAL

Twelve sessions (90 minutes each) of prolonged exposure therapy

Interventions

Prolonged exposure therapy

Twelve sessions (90 minutes each) of prolonged exposure therapy

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Veterans Medical Research Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven R. Thorp, PhD

Role: PRINCIPAL_INVESTIGATOR

Veterans Affairs San Diego Healthcare System

Locations

VA San Diego Healthcare System

San Diego, California, United States

Countries

United States

Other Identifiers

PT074431

Identifier Type: -

Identifier Source: secondary_id

080513

Identifier Type: -

Identifier Source: org_study_id