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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedicine CBT | Experimental | Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. |
|
| In-Person CBT | Active Comparator | Cognitive behaviour therapy (CBT) delivered using in-person consultation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine CBT | Behavioral | Use of Videoconfrence Technology To Provide Cognitive Therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-9 (PHQ-9) | The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zia Agha, MD MS | VA San Diego Healthcare System, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System, San Diego | San Diego | California | 92161 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22662733 | Background | 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. | |
| 22662727 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Telemedicine CBT | Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy |
| FG001 | In-Person CBT | Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Telemedicine CBT | Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy |
| BG001 | In-Person CBT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
1 month and 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telemedicine CBT | Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart arrhythmia | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ER Visit | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zia Agha | University of California San Diego | 858-552-8585 | zagha@ucsd.edu |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| In-Person CBT | Behavioral | In-Person Provision Of Cognitive Therapy |
|
| 6 Month Visit |
| Baseline |
| Patient Health Questionnaire-9 (PHQ-9) | The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression. | Post Visit |
| Patient Health Questionnaire-9 (PHQ-9) | The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression. | 6 Month Visit |
| PTSD Checklist (PCL) | PTSD Checklist-Military Version (PCL). The PCL is a 17-item self-report measure of the 17 DSM-IV symptoms of PTSD. The PCL has a variety of purposes, including screening individuals for PTSD, diagnosing PTSD, and monitoring symptom change during and after treatment. A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 "Not at all" to 5 "Extremely". | Baseline |
| PTSD Checklist (PCL) | PTSD Checklist-Military Version (PCL). The PCL is a 17-item self-report measure of the 17 DSM-IV symptoms of PTSD. The PCL has a variety of purposes, including screening individuals for PTSD, diagnosing PTSD, and monitoring symptom change during and after treatment. A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 "Not at all" to 5 "Extremely". | Post Visit |
| PTSD Checklist (PCL) | PTSD Checklist-Military Version (PCL). The PCL is a 17-item self-report measure of the 17 DSM-IV symptoms of PTSD. The PCL has a variety of purposes, including screening individuals for PTSD, diagnosing PTSD, and monitoring symptom change during and after treatment. A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 "Not at all" to 5 "Extremely". | 6 Month Visit |
Cognitive behaviour therapy (CBT) delivered using in-person consultation.
In-Person CBT: In-Person Provision Of Cognitive Therapy
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Missing Data | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | In-Person CBT | Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Post Visit |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 6 Month Visit |
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|
|
| Secondary | Patient Health Questionnaire-9 (PHQ-9) | The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
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| Secondary | Patient Health Questionnaire-9 (PHQ-9) | The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression. | Posted | Mean | Standard Deviation | units on a scale | Post Visit |
|
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| Secondary | Patient Health Questionnaire-9 (PHQ-9) | The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression. | Posted | Mean | Standard Deviation | units on a scale | 6 Month Visit |
|
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| Secondary | PTSD Checklist (PCL) | PTSD Checklist-Military Version (PCL). The PCL is a 17-item self-report measure of the 17 DSM-IV symptoms of PTSD. The PCL has a variety of purposes, including screening individuals for PTSD, diagnosing PTSD, and monitoring symptom change during and after treatment. A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 "Not at all" to 5 "Extremely". | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
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| Secondary | PTSD Checklist (PCL) | PTSD Checklist-Military Version (PCL). The PCL is a 17-item self-report measure of the 17 DSM-IV symptoms of PTSD. The PCL has a variety of purposes, including screening individuals for PTSD, diagnosing PTSD, and monitoring symptom change during and after treatment. A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 "Not at all" to 5 "Extremely". | Posted | Mean | Standard Deviation | units on a scale | Post Visit |
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| Secondary | PTSD Checklist (PCL) | PTSD Checklist-Military Version (PCL). The PCL is a 17-item self-report measure of the 17 DSM-IV symptoms of PTSD. The PCL has a variety of purposes, including screening individuals for PTSD, diagnosing PTSD, and monitoring symptom change during and after treatment. A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 "Not at all" to 5 "Extremely". | Posted | Mean | Standard Deviation | units on a scale | 6 Month Visit |
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| 0 |
| 103 |
| 0 |
| 103 |
| EG001 | In-Person CBT | Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy | 2 | 104 | 1 | 104 |
| 5150 Danger to self and others | Psychiatric disorders | Non-systematic Assessment |
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