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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01158001
• Other study ID #: 080513
• Secondary ID: PT074431
• Status: Completed
• Phase: N/A
• First received: February 20, 2009
• Last updated: June 22, 2015
• Start date: May 2009
• Est. completion date: September 2012

Study information

• Verified date: June 2015
• Source: Veterans Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: September 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Depression
• Posttraumatic Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Prolonged exposure therapy
Twelve sessions (90 minutes each) of prolonged exposure therapy

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
Veterans Medical Research Foundation	United States Department of Defense, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	PHQ-9 (self-reported depression)	Measure of depressive 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	Yes
Secondary	PTSD Checklist (PCL; self-reported PTSD symptoms)	Measure of 17 posttraumatic stress disorder (PTSD) symptoms from specific event (PCL-S)	Pre-treatment, weekly during 12 weeks of treatment, post-treatment (14 weeks after pre-treatment assessment), follow-up six months after post-treatment assessment	No
Secondary	Neuropsychological testing battery to assess cognitive functioning	Wechsler Test of Adult Reading; Rey Complex Figure task; California Verbal Learning Test; Wisconsin Card Sort Test; Wechsler Adult Intelligence Scale Digit Span; Delis-Kaplan Executive Functioning System (D-KEFS) Verbal Fluency; Delis-Kaplan Executive Functioning System (D-KEFS) Color-Word Interference; Delis-Kaplan Executive Functioning System (D-KEFS) Trails	Pre-treatment and post-treatment (14 weeks after pre-treatment assessment)	No