Trial Outcomes & Findings for PTSD Coach App Evaluation (NCT NCT02445196)
NCT ID: NCT02445196
Last Updated: 2017-04-04
Results Overview
PTSD symptoms were assessed with the PCL-C (Weathers et al., 1993), a 17-item self-report measure of DSM-IV PTSD symptoms with strong psychometric properties (Wilkins, Lang, \& Norman, 2011). Items are rated on how much the symptom bothered the respondent in the past month on a scale ranging from 1 (not at all) to 5 (extremely), with the sum score ranging from 17 to 85 providing a symptom severity rating, with higher ratings indicating more severe PTSD symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
Baseline to Posttreatment (3 months)
Results posted on
2017-04-04
Participant Flow
Participant milestones
| Measure |
PTSD Coach
Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android.
|
Waitlist Control
Subjects assigned to this condition are told: "You have been randomly assigned to Group 2, the group that does not use the app."
Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android.
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
58
|
|
Overall Study
COMPLETED
|
51
|
52
|
|
Overall Study
NOT COMPLETED
|
11
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PTSD Coach App Evaluation
Baseline characteristics by cohort
| Measure |
PTSD Coach
n=62 Participants
Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android.
|
Waitlist Control
n=58 Participants
Subjects assigned to this condition are told: "You have been randomly assigned to Group 2, the group that does not use the app."
Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
58 Participants
n=93 Participants
|
57 Participants
n=4 Participants
|
115 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Age, Continuous
|
39.43 years
STANDARD_DEVIATION 15.16 • n=93 Participants
|
39.12 years
STANDARD_DEVIATION 14.08 • n=4 Participants
|
39.28 years
STANDARD_DEVIATION 14.59 • n=27 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
83 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
62 Participants
n=93 Participants
|
58 Participants
n=4 Participants
|
120 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to Posttreatment (3 months)PTSD symptoms were assessed with the PCL-C (Weathers et al., 1993), a 17-item self-report measure of DSM-IV PTSD symptoms with strong psychometric properties (Wilkins, Lang, \& Norman, 2011). Items are rated on how much the symptom bothered the respondent in the past month on a scale ranging from 1 (not at all) to 5 (extremely), with the sum score ranging from 17 to 85 providing a symptom severity rating, with higher ratings indicating more severe PTSD symptoms.
Outcome measures
| Measure |
PTSD Coach
n=62 Participants
Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android.
|
Waitlist Control
n=58 Participants
Subjects assigned to this condition are told: "You have been randomly assigned to Group 2, the group that does not use the app."
Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android.
|
|---|---|---|
|
Change in PTSD Symptoms Measured by the Post Traumatic Stress Disorder Checklist (PCL)
Baseline
|
63.19 units on a scale
Standard Deviation 11.78
|
60.59 units on a scale
Standard Deviation 10.24
|
|
Change in PTSD Symptoms Measured by the Post Traumatic Stress Disorder Checklist (PCL)
Posttreatment
|
51.93 units on a scale
Standard Deviation 14.04
|
53.90 units on a scale
Standard Deviation 13.78
|
SECONDARY outcome
Timeframe: Baseline to Posttreatment (3 months)PTSD symptom coping SE was assessed with a 9-item self-report measure developed for the study following Bandura's guidelines (Bandura, 2006). Items assess confidence in managing PTSD symptoms and reaching out for support on a scale from 0 (cannot do at all) to 100 (highly certain can do). The average score provides an overall measure of SE with higher scores reflecting greater self-efficacy coping with PTSD symptoms. Cronbach's alpha at baseline was .87.
Outcome measures
| Measure |
PTSD Coach
n=62 Participants
Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android.
|
Waitlist Control
n=58 Participants
Subjects assigned to this condition are told: "You have been randomly assigned to Group 2, the group that does not use the app."
Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android.
|
|---|---|---|
|
Change in Subject Coping Self-efficacy Measured by a Questionnaire Assessing Confidence in Managing Core Symptoms of PTSD Addressed in the Intervention
Baseline
|
49.63 units on a scale
Standard Deviation 19.28
|
50.77 units on a scale
Standard Deviation 19.10
|
|
Change in Subject Coping Self-efficacy Measured by a Questionnaire Assessing Confidence in Managing Core Symptoms of PTSD Addressed in the Intervention
Posttreatment
|
56.09 units on a scale
Standard Deviation 18.35
|
52.36 units on a scale
Standard Deviation 19.16
|
SECONDARY outcome
Timeframe: Baseline to Posttreatment (3 months)Psychosocial functioning was measured using the Brief Inventory of Psychosocial Functioning (B-IPF; Erb, Kearns, Bovin et al., 2015), a 7-item self-report measure. Items are rated on how much trouble the respondent had in the past month in relationships or other important areas of functioning (e.g., work, training or education) on a scale ranging from 0 (not at all) to 6 (very much). An average of applicable items provides an index of psychosocial functioning, with higher scores reflecting more poorer psychosocial functioning. Cronbach's alpha at baseline was .82.
Outcome measures
| Measure |
PTSD Coach
n=62 Participants
Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android.
|
Waitlist Control
n=58 Participants
Subjects assigned to this condition are told: "You have been randomly assigned to Group 2, the group that does not use the app."
Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android.
|
|---|---|---|
|
Change in Interpersonal Functioning Measured by a Brief Inventory of Psychosocial Functioning (IPF7)
Baseline
|
3.85 units on a scale
Standard Deviation 1.55
|
3.15 units on a scale
Standard Deviation 1.40
|
|
Change in Interpersonal Functioning Measured by a Brief Inventory of Psychosocial Functioning (IPF7)
Posttreatment
|
2.86 units on a scale
Standard Deviation 1.47
|
2.91 units on a scale
Standard Deviation 1.49
|
SECONDARY outcome
Timeframe: Baseline to Posttreatment (3 months)Depression was assessed with the Patient Health Questionnaire depression scale (PHQ-8; Kroenke et al., 2009), an 8-item self-report measure of depression with evidence showing its ability to measure depression symptom severity and potential diagnosis. Items are rated on how much the symptom bothered the respondent in the past two weeks on a scale ranging from 0 (not at all) to 3 (nearly every day). Total scores can range from 0 to 24, with higher scores indicating more severe depression symptoms. Cronbach's alpha at baseline was .87.
Outcome measures
| Measure |
PTSD Coach
n=62 Participants
Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android.
|
Waitlist Control
n=58 Participants
Subjects assigned to this condition are told: "You have been randomly assigned to Group 2, the group that does not use the app."
Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android.
|
|---|---|---|
|
Change in Depression Symptoms Measured by the Patient Health Questionnaire (PHQ8)
Baseline
|
15.06 units on a scale
Standard Deviation 6.36
|
13.62 units on a scale
Standard Deviation 5.55
|
|
Change in Depression Symptoms Measured by the Patient Health Questionnaire (PHQ8)
Posttreatment
|
11.03 units on a scale
Standard Deviation 5.29
|
12.31 units on a scale
Standard Deviation 5.88
|
SECONDARY outcome
Timeframe: Postreatment to 3-month Follow-upPTSD symptoms were assessed with the PCL-C (Weathers et al., 1993), a 17-item self-report measure of DSM-IV PTSD symptoms with strong psychometric properties (Wilkins, Lang, \& Norman, 2011). Items are rated on how much the symptom bothered the respondent in the past month on a scale ranging from 1 (not at all) to 5 (extremely), with the sum score ranging from 17 to 85 providing a symptom severity rating, with higher ratings indicating more severe PTSD symptoms.
Outcome measures
| Measure |
PTSD Coach
n=62 Participants
Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android.
|
Waitlist Control
Subjects assigned to this condition are told: "You have been randomly assigned to Group 2, the group that does not use the app."
Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android.
|
|---|---|---|
|
Sustained Change in PTSD Symptoms Measured by the Post Traumatic Stress Disorder Checklist (PCL)
Posttreatment
|
51.93 units on a scale
Standard Deviation 14.04
|
—
|
|
Sustained Change in PTSD Symptoms Measured by the Post Traumatic Stress Disorder Checklist (PCL)
3-Month Follow-up
|
49.15 units on a scale
Standard Deviation 13.94
|
—
|
Adverse Events
PTSD Coach
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place