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Trial Outcomes & Findings for Veterans Telemedicine Outreach for PTSD Services (NCT NCT00645047)

NCT ID: NCT00645047

Last Updated: 2017-04-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

207 participants

Primary outcome timeframe

Baseline

Results posted on

2017-04-14

Participant Flow

Participant milestones

Participant milestones
Measure
Telemedicine CBT
Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy
In-Person CBT
Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy
Overall Study
STARTED
103
104
Overall Study
Post
74
80
Overall Study
COMPLETED
60
65
Overall Study
NOT COMPLETED
43
39

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Missing Data

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Telemedicine CBT
n=103 Participants
Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy
In-Person CBT
n=104 Participants
Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy
Total
n=207 Participants
Total of all reporting groups
Age, Continuous
51.4 years
STANDARD_DEVIATION 14.1 • n=103 Participants
45.6 years
STANDARD_DEVIATION 13.5 • n=104 Participants
48.4 years
STANDARD_DEVIATION 14.1 • n=207 Participants
Sex: Female, Male
Female
19 Participants
n=97 Participants • Missing Data
26 Participants
n=102 Participants • Missing Data
45 Participants
n=199 Participants • Missing Data
Sex: Female, Male
Male
78 Participants
n=97 Participants • Missing Data
76 Participants
n=102 Participants • Missing Data
154 Participants
n=199 Participants • Missing Data
Region of Enrollment
United States
103 participants
n=103 Participants
104 participants
n=104 Participants
207 participants
n=207 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Telemedicine CBT
n=103 Participants
Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy
In-Person CBT
n=104 Participants
Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy
CAPS - PTSD Symptom Severity Score
71.3 units on a scale
Standard Deviation 17.8
72.5 units on a scale
Standard Deviation 18.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Telemedicine CBT
n=74 Participants
Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy
In-Person CBT
n=80 Participants
Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy
CAPS - PTSD Symptom Severity Score
62.1 units on a scale
Standard Deviation 27.5
53.4 units on a scale
Standard Deviation 26.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Telemedicine CBT
n=60 Participants
Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy
In-Person CBT
n=65 Participants
Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy
CAPS - PTSD Symptom Severity Score
56.6 units on a scale
Standard Deviation 28.5
57.3 units on a scale
Standard Deviation 26.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Telemedicine CBT
n=103 Participants
Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy
In-Person CBT
n=104 Participants
Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy
Patient Health Questionnaire-9 (PHQ-9)
15.6 units on a scale
Standard Deviation 6.5
16.4 units on a scale
Standard Deviation 12.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Telemedicine CBT
n=74 Participants
Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy
In-Person CBT
n=80 Participants
Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy
Patient Health Questionnaire-9 (PHQ-9)
12.9 units on a scale
Standard Deviation 7.2
12.7 units on a scale
Standard Deviation 6.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Telemedicine CBT
n=60 Participants
Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy
In-Person CBT
n=65 Participants
Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy
Patient Health Questionnaire-9 (PHQ-9)
12.5 units on a scale
Standard Deviation 6.8
13.3 units on a scale
Standard Deviation 6.9

SECONDARY outcome

Timeframe: 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".

Outcome measures

Outcome measures
Measure
Telemedicine CBT
n=103 Participants
Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy
In-Person CBT
n=104 Participants
Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy
PTSD Checklist (PCL)
59.1 units on a scale
Standard Deviation 13.7
58.5 units on a scale
Standard Deviation 12.6

SECONDARY outcome

Timeframe: 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".

Outcome measures

Outcome measures
Measure
Telemedicine CBT
n=74 Participants
Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy
In-Person CBT
n=80 Participants
Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy
PTSD Checklist (PCL)
51.3 units on a scale
Standard Deviation 16.3
49.3 units on a scale
Standard Deviation 16.7

SECONDARY outcome

Timeframe: 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".

Outcome measures

Outcome measures
Measure
Telemedicine CBT
n=60 Participants
Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy
In-Person CBT
n=65 Participants
Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy
PTSD Checklist (PCL)
48.3 units on a scale
Standard Deviation 17.0
51.5 units on a scale
Standard Deviation 16.7

Adverse Events

Telemedicine CBT

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

In-Person CBT

Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Telemedicine CBT
n=103 participants at risk
Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy
In-Person CBT
n=104 participants at risk
Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy
Cardiac disorders
Heart arrhythmia
0.00%
0/103 • 1 month and 6 months
0.96%
1/104 • Number of events 1 • 1 month and 6 months
Psychiatric disorders
5150 Danger to self and others
0.00%
0/103 • 1 month and 6 months
1.9%
2/104 • Number of events 2 • 1 month and 6 months

Other adverse events

Other adverse events
Measure
Telemedicine CBT
n=103 participants at risk
Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine. Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy
In-Person CBT
n=104 participants at risk
Cognitive behaviour therapy (CBT) delivered using in-person consultation. In-Person CBT: In-Person Provision Of Cognitive Therapy
Gastrointestinal disorders
ER Visit
0.00%
0/103 • 1 month and 6 months
0.96%
1/104 • Number of events 1 • 1 month and 6 months

Additional Information

Zia Agha

University of California San Diego

Phone: 858-552-8585

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60