Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


NCT number NCT00645047
Study type Interventional
Source VA Office of Research and Development
Contact
Status Completed
Phase N/A
Start date February 2009
Completion date April 2012

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03962504 - Written Exposure Therapy Versus Prolonged Exposure: a Non-inferiority Trial N/A
Completed NCT01995123 - Behavioral Activation for Smoking Cessation in PTSD N/A
Not yet recruiting NCT06278922 - Evaluating Signs of Safety: A Deaf-Accessible Therapy Toolkit for AUD and Trauma N/A
Completed NCT04597450 - Lu AG06466 in Participants With Post Traumatic Stress Disorder (PTSD) Phase 1
Completed NCT03593772 - Mission Reconnect- Delivering a Mobile and Web Based Self Directed Complementary And Integrative Health Program to Veterans and Their Partners to Manage Pain and PTSD N/A
Completed NCT03429166 - Connecting Women to Care: Home-based Psychotherapy for Women With MST Living in Rural Areas N/A
Recruiting NCT04317820 - Deep Brain Reorienting in Post-traumatic Stress Disorder N/A
Active, not recruiting NCT04588883 - Strengthening Families Living With HIV in Kenya N/A
Completed NCT03504722 - Evaluating the Feasibility of RESCUE: An Adjunctive HAI-Based Intervention for Veterans With PTSD N/A
Completed NCT04305353 - Intensive Care Unit (ICU) Diary Project N/A
Completed NCT03113890 - McLean and Genomind Prospective Study N/A
Withdrawn NCT05173831 - Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans Phase 2
Not yet recruiting NCT04056767 - Changes in Digital Phenotype During PE Therapy
Withdrawn NCT03924297 - Chilipad for Sleep and Symptoms of PTSD N/A
Withdrawn NCT03216356 - Effect of D-cycloserine on a Short Imagery Rescripting Intervention for Subclinical PTSD Phase 2/Phase 3
Completed NCT03343028 - Biomarker Establishment for Superior Treatment of PTSD
Completed NCT03158558 - Intensive Weekend Retreat Multi-Couple Group Therapy for PTSD N/A
Completed NCT02370173 - A Non-Pharmacological Method for Enhancing Sleep in PTSD N/A
Withdrawn NCT01957371 - Mindful Yoga Therapy for Veterans With PTSD and Pain N/A
Completed NCT01911585 - Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure N/A