VTOPS: Veterans Telemedicine Outreach for PTSD Services
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Telemedicine CBT Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. |
Behavioral: Telemedicine CBT
Use of Videoconfrence Technology To Provide Cognitive Therapy
|
| Active Comparator: In-Person CBT Cognitive behaviour therapy (CBT) delivered using in-person consultation. |
Behavioral: In-Person CBT
In-Person Provision Of Cognitive Therapy
|
Outcome Measures
Primary Outcome Measures
- CAPS - PTSD Symptom Severity Score [Baseline]
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.
- CAPS - PTSD Symptom Severity Score [Post Visit]
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.
- CAPS - PTSD Symptom Severity Score [6 Month Visit]
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.
Secondary Outcome Measures
- Patient Health Questionnaire-9 (PHQ-9) [Baseline]
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.
- Patient Health Questionnaire-9 (PHQ-9) [Post Visit]
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.
- Patient Health Questionnaire-9 (PHQ-9) [6 Month Visit]
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.
- PTSD Checklist (PCL) [Baseline]
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".
- PTSD Checklist (PCL) [Post Visit]
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".
- PTSD Checklist (PCL) [6 Month Visit]
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".
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA San Diego Healthcare System, San Diego | San Diego | California | United States | 92161 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Zia Agha, MD MS, VA San Diego Healthcare System, San Diego
Study Documents (Full-Text)
None provided.More Information
Publications
- DHI 07-054
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Telemedicine CBT | In-Person CBT |
|---|---|---|
| Arm/Group Description | Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy | Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy |
| Period Title: Overall Study | ||
| STARTED | 103 | 104 |
| Post | 74 | 80 |
| COMPLETED | 60 | 65 |
| NOT COMPLETED | 43 | 39 |
Baseline Characteristics
| Arm/Group Title | Telemedicine CBT | In-Person CBT | Total |
|---|---|---|---|
| Arm/Group Description | Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy | Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy | Total of all reporting groups |
| Overall Participants | 103 | 104 | 207 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
51.4
(14.1)
|
45.6
(13.5)
|
48.4
(14.1)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
19
18.4%
|
26
25%
|
45
21.7%
|
| Male |
78
75.7%
|
76
73.1%
|
154
74.4%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
103
100%
|
104
100%
|
207
100%
|
Outcome Measures
| Title | CAPS - PTSD Symptom Severity Score |
|---|---|
| Description | 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. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Telemedicine CBT | In-Person CBT |
|---|---|---|
| Arm/Group Description | Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy | Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy |
| Measure Participants | 103 | 104 |
| Mean (Standard Deviation) [units on a scale] |
71.3
(17.8)
|
72.5
(18.4)
|
| Title | CAPS - PTSD Symptom Severity Score |
|---|---|
| Description | 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. |
| Time Frame | Post Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Telemedicine CBT | In-Person CBT |
|---|---|---|
| Arm/Group Description | Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy | Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy |
| Measure Participants | 74 | 80 |
| Mean (Standard Deviation) [units on a scale] |
62.1
(27.5)
|
53.4
(26.2)
|
| Title | CAPS - PTSD Symptom Severity Score |
|---|---|
| Description | 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. |
| Time Frame | 6 Month Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Telemedicine CBT | In-Person CBT |
|---|---|---|
| Arm/Group Description | Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy | Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy |
| Measure Participants | 60 | 65 |
| Mean (Standard Deviation) [units on a scale] |
56.6
(28.5)
|
57.3
(26.9)
|
| Title | Patient Health Questionnaire-9 (PHQ-9) |
|---|---|
| Description | 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. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Telemedicine CBT | In-Person CBT |
|---|---|---|
| Arm/Group Description | Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy | Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy |
| Measure Participants | 103 | 104 |
| Mean (Standard Deviation) [units on a scale] |
15.6
(6.5)
|
16.4
(12.7)
|
| Title | Patient Health Questionnaire-9 (PHQ-9) |
|---|---|
| Description | 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. |
| Time Frame | Post Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Telemedicine CBT | In-Person CBT |
|---|---|---|
| Arm/Group Description | Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy | Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy |
| Measure Participants | 74 | 80 |
| Mean (Standard Deviation) [units on a scale] |
12.9
(7.2)
|
12.7
(6.7)
|
| Title | Patient Health Questionnaire-9 (PHQ-9) |
|---|---|
| Description | 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. |
| Time Frame | 6 Month Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Telemedicine CBT | In-Person CBT |
|---|---|---|
| Arm/Group Description | Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy | Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy |
| Measure Participants | 60 | 65 |
| Mean (Standard Deviation) [units on a scale] |
12.5
(6.8)
|
13.3
(6.9)
|
| Title | PTSD Checklist (PCL) |
|---|---|
| Description | 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". |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Telemedicine CBT | In-Person CBT |
|---|---|---|
| Arm/Group Description | Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy | Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy |
| Measure Participants | 103 | 104 |
| Mean (Standard Deviation) [units on a scale] |
59.1
(13.7)
|
58.5
(12.6)
|
| Title | PTSD Checklist (PCL) |
|---|---|
| Description | 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". |
| Time Frame | Post Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Telemedicine CBT | In-Person CBT |
|---|---|---|
| Arm/Group Description | Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy | Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy |
| Measure Participants | 74 | 80 |
| Mean (Standard Deviation) [units on a scale] |
51.3
(16.3)
|
49.3
(16.7)
|
| Title | PTSD Checklist (PCL) |
|---|---|
| Description | 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". |
| Time Frame | 6 Month Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Telemedicine CBT | In-Person CBT |
|---|---|---|
| Arm/Group Description | Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy | Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy |
| Measure Participants | 60 | 65 |
| Mean (Standard Deviation) [units on a scale] |
48.3
(17.0)
|
51.5
(16.7)
|
Adverse Events
| Time Frame | 1 month and 6 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Telemedicine CBT | In-Person CBT | ||
| Arm/Group Description | Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy | Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy | ||
All Cause Mortality |
||||
| Telemedicine CBT | In-Person CBT | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Telemedicine CBT | In-Person CBT | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/103 (0%) | 2/104 (1.9%) | ||
| Cardiac disorders | ||||
| Heart arrhythmia | 0/103 (0%) | 0 | 1/104 (1%) | 1 |
| Psychiatric disorders | ||||
| 5150 Danger to self and others | 0/103 (0%) | 0 | 2/104 (1.9%) | 2 |
Other (Not Including Serious) Adverse Events |
||||
| Telemedicine CBT | In-Person CBT | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/103 (0%) | 1/104 (1%) | ||
| Gastrointestinal disorders | ||||
| ER Visit | 0/103 (0%) | 0 | 1/104 (1%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Zia Agha |
|---|---|
| Organization | University of California San Diego |
| Phone | 858-552-8585 |
| zagha@ucsd.edu |
- DHI 07-054