Clinical trial NCT00645047: Veterans Telemedicine Outreach for PTSD Services
Official title: Veterans Telemedicine Outreach for PTSD Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Keywords: PTSD
Telemedicine
Patient-Centered Care
Professional Patient Relationship
Psychotherapy
Cognitive Therapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-03-27
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Anticipated Impact on Veterans' Healthcare: This project addresses two very important and timely questions related to the VHA's mission to provide state of the art care to OEF and OIF veterans. 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.

Project Background/Rationale: 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.

However, recently developed evidenced based treatments like CPT are very effective. Unfortunately, these treatments are not widely available, as a large proportion of veterans live in rural communities and have poor access to specialized mental health care. The VA hospital system currently supports sophisticated telemedicine technology that can provide CPT to veterans in their home communities. The proposed project will assess the quality of CPT provided via telemedicine and its impact on outcomes, and is therefore, directly related to the VA's mission to provide advanced, accessible, and high quality health care to all eligible veterans regardless of place of residence: "Right care in the right place, at the right time".

Project Objectives: The objective of the proposed study is to conduct a systematic comparison of PTSD outcomes for veterans receiving cognitive processing therapy via telemedicine vs. in-person care. The patient-therapist relationship is central in establishing an effective therapeutic relationship and is strongly influenced by communication. Consequently, this project will also compare provider-patient communication during telemedicine consultations vs. in-person consultations.

Project Methods: We propose a randomized clinical trial of 254 patients receiving cognitive processing therapy either via telemedicine or by in-person care. Telemedicine visits will occur at La Jolla VA in San Diego and in-person visits will occur at the Mission Valley VA Clinic in San Diego. Veterans with PTSD will be enrolled from the primary care and mental health clinics at the above sites. Clinical services will be provided by 10 participating providers with specialized training in CPT. Therapy will be provided over 12 weekly sessions lasting 60 minutes each. Previously validated and widely used measures of PTSD symptom severity (Clinician-Administered PTSD Scale, PTSD Checklist ) and health related quality of life (SF-36) will be measured at baseline, at completion of therapy, and at 6 months follow-up. In addition, we will measure and compare the quality of verbal and non-verbal patient-provider communication for in-person and telemedicine visits via video recordings of visits, which will be analyzed using the Roter Interaction Analyses System. Patient and provider satisfaction will be measured post therapy with previously validated questionnaires. Statistical methods will include descriptive analyses, reliability analyses, and hypothesis testing using linear mixed models.

Eligibility criteria: Inclusion Criteria:

1. 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;
2. age 18 or older; and
3. English fluency.

Exclusion Criteria:

1. unmanaged dementia, psychosis or manic episodes in past year;
2. substance abuse or alcohol dependence in past year as measured by AUDIT;
3. 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);
4. severe cardiovascular or respiratory disease that would make it difficult to ensure regular attendance at psychotherapy sessions;
5. severe impairments in speech, vision, or hearing; and
6. head trauma resulting in loss of consciousness longer than 20 minutes.

Primary outcomes:
measure: CAPS - PTSD Symptom Severity Score
timeFrame: Baseline
measure: CAPS - PTSD Symptom Severity Score
timeFrame: Post Visit
measure: CAPS - PTSD Symptom Severity Score
timeFrame: 6 Month Visit
Secondary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Post Visit
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 6 Month Visit
measure: PTSD Checklist (PCL)
timeFrame: Baseline
measure: PTSD Checklist (PCL)
timeFrame: Post Visit
measure: PTSD Checklist (PCL)
timeFrame: 6 Month Visit
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego
name: Zia Agha, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.