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Clinician-Supported PTSD Coach vs. Self-Managed PTSD Coach

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ClinicalTrials.gov Identifier: NCT02400710
Recruitment Status : Completed
First Posted : March 27, 2015
Results First Posted : February 3, 2016
Last Update Posted : February 3, 2016
Sponsor:
Information provided by (Responsible Party):
Kyle Possemato, Syracuse VA Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition PTSD
Interventions Behavioral: Clinician-Supported PTSD Coach
Behavioral: Self-Managed PTSD Coach
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clinician-Supported PTSD Coach Self-Managed PTSD Coach
Hide Arm/Group Description

Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.

Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care.

One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.

Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app.

Period Title: Overall Study
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Clinician-Supported PTSD Coach Self-Managed PTSD Coach Total
Hide Arm/Group Description

Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.

Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care.

One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.

Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app.

Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
Participants completed self-report measures at baseline.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
41.0  (7.8) 42.8  (15.4) 41.9  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
1
  10.0%
0
   0.0%
1
   5.0%
Male
9
  90.0%
10
 100.0%
19
  95.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Hispanic or Latino
0
   0.0%
1
  10.0%
1
   5.0%
Not Hispanic or Latino
10
 100.0%
9
  90.0%
19
  95.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
American Indian or Alaska Native
2
  20.0%
1
  10.0%
3
  15.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  20.0%
2
  20.0%
4
  20.0%
White
6
  60.0%
7
  70.0%
13
  65.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
PTSD Checklist-Specific   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 10 participants 10 participants 20 participants
51.0  (7.7) 56.0  (15.3) 53.5  (12.0)
[1]
Measure Description: Measures the 17 symptoms of PTSD according to the DSM-IV criteria. Each symptom is measured on a 5-point scale ranging from 1-5, with higher numbers equating to more severe symptoms. Measures range is 17-85. The mean provided is for the total score of all symptoms added together.
1.Primary Outcome
Title PTSD Checklist-Specific
Hide Description Measures the 17 symptoms of PTSD according to the DSM-IV. Each symptoms is measured on a 1-5 scale, with higher numbers indicated greater severity. The total range of the scale is 17-85.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clinician-Supported PTSD Coach Self-Managed PTSD Coach
Hide Arm/Group Description:

Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.

Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care.

One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.

Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
40.0  (10.9) 49.8  (18.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clinician-Supported PTSD Coach, Self-Managed PTSD Coach
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Engagement in PTSD Specialty Care as Measured by the Electronic Medical Record
Hide Description Attendance of at least one session in the PTSD specialty clinic following the completion of the study intervention.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clinician-Supported PTSD Coach Self-Managed PTSD Coach
Hide Arm/Group Description:

Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.

Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care.

One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.

Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app.

Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: participants
7 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clinician-Supported PTSD Coach, Self-Managed PTSD Coach
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clinician-Supported PTSD Coach Self-Managed PTSD Coach
Hide Arm/Group Description

Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.

Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care.

One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.

Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app.

All-Cause Mortality
Clinician-Supported PTSD Coach Self-Managed PTSD Coach
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Clinician-Supported PTSD Coach Self-Managed PTSD Coach
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clinician-Supported PTSD Coach Self-Managed PTSD Coach
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kyle Possemato, Ph.D.
Organization: Center for Integrated Healthcare, Syracuse Veterans Affairs Medical Center
Phone: 315-425-4400 ext 53551
EMail: kyle.possmato@va.gov
Layout table for additonal information
Responsible Party: Kyle Possemato, Syracuse VA Medical Center
ClinicalTrials.gov Identifier: NCT02400710     History of Changes
Other Study ID Numbers: 00615
First Submitted: March 16, 2015
First Posted: March 27, 2015
Results First Submitted: November 19, 2015
Results First Posted: February 3, 2016
Last Update Posted: February 3, 2016