Veterans Telemedicine Outreach for PTSD Services

NCT00645047 | Completed Results

• 1 other identifier: DHI 07-054
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

Brief Summary

Post-Traumatic Stress Disorder (PTSD) is considered a major public health problem in the U.S. due to its high prevalence and high rates of disability associated with the disorder. For thousands of veterans, PTSD is a chronic disorder, resulting directly from military service that causes substantial psychological suffering and social disability. Barriers to PTSD care include poor access, mistrust, and lack of benefit from traditional treatments. This project addresses two very important and timely questions. First, can telemedicine be used as a tool to extend effective, specialized mental health services such as, cognitive processing therapy (CPT), to veterans with poor access to care? Second, does therapy delivered by telemedicine effect the quality of care in terms of clinical outcomes (PTSD severity, Quality of Life), and the quality of patient-therapist interaction (patient satisfaction \& communication)? By answering these questions, this study will provide valuable knowledge for VA researchers, clinicians, and policy makers. The study findings will have direct implications related to making specific recommendations regarding telemedicine utilization to deliver specialized mental health services for veterans suffering from PTSD.

Conditions

PTSD

Keywords

PTSD; Telemedicine; Patient-Centered Care; Professional Patient Relationship; Psychotherapy; Cognitive Therapy

Outcome Measures

Primary Outcomes (3)

• CAPS - PTSD Symptom Severity Score

  The CAPS-5 is a 30-item clinician administered interview designed to diagnose current and lifetime PTSD and to assess PTSD symptom-severity over the past week. The interview assesses 20 DSM-5 PTSD symptoms as well as onset, duration, distress, and functional impact, overall validity, PTSD severity, and presence of dissociation. Prior to assessing symptoms, the clinical interviewer works with the patient to establish an index-trauma and each follow-up question focuses on symptoms as they relate to the index trauma. Severity Rating 0\. Absent; 1. Mild / subthreshold; 2. Moderate / threshold; 3. Severe / markedly elevated; and 4. Extreme / incapacitating. Higher scores means more severe symptoms. Total symptom severity score may range from 0-80, higher scores meaning more severe symptoms.

  Baseline

• CAPS - PTSD Symptom Severity Score

  The CAPS-5 is a 30-item clinician administered interview designed to diagnose current and lifetime PTSD and to assess PTSD symptom-severity over the past week. The interview assesses 20 DSM-5 PTSD symptoms as well as onset, duration, distress, and functional impact, overall validity, PTSD severity, and presence of dissociation. Prior to assessing symptoms, the clinical interviewer works with the patient to establish an index-trauma and each follow-up question focuses on symptoms as they relate to the index trauma. Severity Rating 0\. Absent; 1. Mild / subthreshold; 2. Moderate / threshold; 3. Severe / markedly elevated; and 4. Extreme / incapacitating. Higher scores means more severe symptoms. Total symptom severity score may range from 0-80, higher scores meaning more severe symptoms.

  Post Visit

• CAPS - PTSD Symptom Severity Score

  The CAPS-5 is a 30-item clinician administered interview designed to diagnose current and lifetime PTSD and to assess PTSD symptom-severity over the past week. The interview assesses 20 DSM-5 PTSD symptoms as well as onset, duration, distress, and functional impact, overall validity, PTSD severity, and presence of dissociation. Prior to assessing symptoms, the clinical interviewer works with the patient to establish an index-trauma and each follow-up question focuses on symptoms as they relate to the index trauma. Severity Rating 0\. Absent; 1. Mild / subthreshold; 2. Moderate / threshold; 3. Severe / markedly elevated; and 4. Extreme / incapacitating. Higher scores means more severe symptoms. Total symptom severity score may range from 0-80, higher scores meaning more severe symptoms.

  6 Month Visit

Secondary Outcomes (6)

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline

• Patient Health Questionnaire-9 (PHQ-9)

  Post Visit

• Patient Health Questionnaire-9 (PHQ-9)

  6 Month Visit

• PTSD Checklist (PCL)

  Baseline

• PTSD Checklist (PCL)

  Post Visit

Study Arms (2)

Telemedicine CBT

EXPERIMENTAL

Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.

Behavioral: Telemedicine CBT

In-Person CBT

ACTIVE COMPARATOR

Cognitive behaviour therapy (CBT) delivered using in-person consultation.

Behavioral: In-Person CBT

Interventions

Telemedicine CBT BEHAVIORAL

Use of Videoconfrence Technology To Provide Cognitive Therapy

Telemedicine CBT

In-Person CBT BEHAVIORAL

In-Person Provision Of Cognitive Therapy

In-Person CBT

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary diagnosis of chronic PTSD due to combat; co-morbid 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; the proposed treatment often ameliorates depression and anxiety symptoms;
• age 18 or older; and
• English fluency.

You may not qualify if:

• unmanaged dementia, psychosis or manic episodes in past year;
• substance abuse or alcohol dependence in past year as measured by AUDIT;
• concurrent psychotherapies targeting PTSD or depression (veterans who are engaged in treatment for non-PTSD symptoms, for example, 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;
• severe impairments in speech, vision, or hearing; and
• head trauma resulting in loss of consciousness longer than 20 minutes.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego

San Diego, California, 92161, United States

Location

Related Publications (2)

• Thorp SR, Fidler J, Moreno L, Floto E, Agha Z. Lessons learned from studies of psychotherapy for posttraumatic stress disorder via video teleconferencing. Psychol Serv. 2012 May;9(2):197-9. doi: 10.1037/a0027057.

  PMID: 22662733 BACKGROUND

• Backhaus A, Agha Z, Maglione ML, Repp A, Ross B, Zuest D, Rice-Thorp NM, Lohr J, Thorp SR. Videoconferencing psychotherapy: a systematic review. Psychol Serv. 2012 May;9(2):111-131. doi: 10.1037/a0027924.

  PMID: 22662727 RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Zia Agha
• Organization: University of California San Diego

zagha@ucsd.edu

858-552-8585

Study Officials

• Zia Agha, MD MS

  VA San Diego Healthcare System, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2008
• First Posted: March 27, 2008
• Study Start: February 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 14, 2017
• Results First Posted: April 14, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)