Trial Outcomes & Findings for Cognitive Training for PTSD (NCT NCT03316196)
NCT ID: NCT03316196
Last Updated: 2024-09-19
Results Overview
This semi-structured interview is designed to measure posttraumatic stress disorder diagnostic status as well as symptoms severity. Total scores range from 0 to 20 with higher scores indicating greater severity; change over time will be evaluated.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
81 participants
Primary outcome timeframe
Pre to Post Intervention (baseline to week 8)
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
COGENT
Participants will be Veterans assigned to the active cognitive training (see below for details).
COGENT COGNITIVE TRAINING: Computer-administered cognitive training program. COGENT is a modified working memory capacity task designed to train cognitive functioning. COGENT was designed to contain high interference across trials. By requiring repeated practice with utilization of interference control across trials, COGENT is thought to enhance plasticity of cognitive systems and improve performance. That is, training is based on the premise that learning-based neural changes will occur via repeated exposure to a task demanding cognitive control resources
|
Non-Training
Participants will be Veterans assigned to a non-training cognitive program matched for time and memory demands (see below for details).
Non training computer condition: The non-training condition requires participants to complete a similar computer task for the same length of time. The non-training is a modified working memory capacity task designed to be inert. The non-training condition was designed to contain relatively less interference demands across trials. Participants are required to remember the same total number of items as in COGENT (i.e., storage requirements were equivalent), but the task contains relatively less interference inherent in the task.
|
|---|---|---|
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Overall Study
STARTED
|
42
|
39
|
|
Overall Study
COMPLETED
|
35
|
28
|
|
Overall Study
NOT COMPLETED
|
7
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cognitive Training for PTSD
Baseline characteristics by cohort
| Measure |
COGENT
n=42 Participants
Participants will be Veterans assigned to the active cognitive training (see below for details).
COGENT COGNITIVE TRAINING: Computer-administered cognitive training program. COGENT is a modified working memory capacity task designed to train cognitive functioning. COGENT was designed to contain high interference across trials. By requiring repeated practice with utilization of interference control across trials, COGENT is thought to enhance plasticity of cognitive systems and improve performance. That is, training is based on the premise that learning-based neural changes will occur via repeated exposure to a task demanding cognitive control resources
|
Non-Training
n=39 Participants
Participants will be Veterans assigned to a non-training cognitive program matched for time and memory demands (see below for details).
Non training computer condition: The non-training condition requires participants to complete a similar computer task for the same length of time. The non-training is a modified working memory capacity task designed to be inert. The non-training condition was designed to contain relatively less interference demands across trials. Participants are required to remember the same total number of items as in COGENT (i.e., storage requirements were equivalent), but the task contains relatively less interference inherent in the task.
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Total
n=81 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
37.57 years
STANDARD_DEVIATION 8.53 • n=5 Participants
|
37.77 years
STANDARD_DEVIATION 8.21 • n=7 Participants
|
37.67 years
STANDARD_DEVIATION 8.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre to Post Intervention (baseline to week 8)This semi-structured interview is designed to measure posttraumatic stress disorder diagnostic status as well as symptoms severity. Total scores range from 0 to 20 with higher scores indicating greater severity; change over time will be evaluated.
Outcome measures
| Measure |
COGENT
n=35 Participants
Participants will be Veterans assigned to the active cognitive training (see below for details).
COGENT COGNITIVE TRAINING: Computer-administered cognitive training program. COGENT is a modified working memory capacity task designed to train cognitive functioning. COGENT was designed to contain high interference across trials. By requiring repeated practice with utilization of interference control across trials, COGENT is thought to enhance plasticity of cognitive systems and improve performance. That is, training is based on the premise that learning-based neural changes will occur via repeated exposure to a task demanding cognitive control resources
|
Non-Training
n=28 Participants
Participants will be Veterans assigned to a non-training cognitive program matched for time and memory demands (see below for details).
Non training computer condition: The non-training condition requires participants to complete a similar computer task for the same length of time. The non-training is a modified working memory capacity task designed to be inert. The non-training condition was designed to contain relatively less interference demands across trials. Participants are required to remember the same total number of items as in COGENT (i.e., storage requirements were equivalent), but the task contains relatively less interference inherent in the task.
|
|---|---|---|
|
Clinician Administered PTSD Scale - Reexperiencing
|
2.6 score on a scale
Standard Deviation 2.9
|
2.96 score on a scale
Standard Deviation 3.2
|
PRIMARY outcome
Timeframe: Pre to Post Intervention (baseline to week 8)Population: Individuals who did not complete the neurocognitive assessment due to COVID protocols are not included in analyses
The Delis-Kaplan Executive Functioning System (DKEFS). This neuropsychological battery is designed to assess cognitive abilities in the executive functioning domain. Two relevant subtests, the Trail Making test and Color Word Interference Test, will be used. Total scores are calculated using a normed t score ranging from 0 to 100 with higher scores indicating better performance; change over time will be evaluated.
Outcome measures
| Measure |
COGENT
n=18 Participants
Participants will be Veterans assigned to the active cognitive training (see below for details).
COGENT COGNITIVE TRAINING: Computer-administered cognitive training program. COGENT is a modified working memory capacity task designed to train cognitive functioning. COGENT was designed to contain high interference across trials. By requiring repeated practice with utilization of interference control across trials, COGENT is thought to enhance plasticity of cognitive systems and improve performance. That is, training is based on the premise that learning-based neural changes will occur via repeated exposure to a task demanding cognitive control resources
|
Non-Training
n=12 Participants
Participants will be Veterans assigned to a non-training cognitive program matched for time and memory demands (see below for details).
Non training computer condition: The non-training condition requires participants to complete a similar computer task for the same length of time. The non-training is a modified working memory capacity task designed to be inert. The non-training condition was designed to contain relatively less interference demands across trials. Participants are required to remember the same total number of items as in COGENT (i.e., storage requirements were equivalent), but the task contains relatively less interference inherent in the task.
|
|---|---|---|
|
Delis-Kaplan Executive Functioning System
|
-.36 score on a scale
Standard Deviation 1.72
|
-1.33 score on a scale
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: Pre to Post Intervention (baseline to week 8)Population: Individuals who did not complete the neurocognitive assessment due to COVID protocols are not included in analyses
The Reading Span task is a working memory capacity assessment participants complete while undergoing functional MRI. Neural activation to task condition is measured using % signal change (0-100) with higher scores indicating greater activation; change over time will be evaluated.
Outcome measures
| Measure |
COGENT
n=14 Participants
Participants will be Veterans assigned to the active cognitive training (see below for details).
COGENT COGNITIVE TRAINING: Computer-administered cognitive training program. COGENT is a modified working memory capacity task designed to train cognitive functioning. COGENT was designed to contain high interference across trials. By requiring repeated practice with utilization of interference control across trials, COGENT is thought to enhance plasticity of cognitive systems and improve performance. That is, training is based on the premise that learning-based neural changes will occur via repeated exposure to a task demanding cognitive control resources
|
Non-Training
n=12 Participants
Participants will be Veterans assigned to a non-training cognitive program matched for time and memory demands (see below for details).
Non training computer condition: The non-training condition requires participants to complete a similar computer task for the same length of time. The non-training is a modified working memory capacity task designed to be inert. The non-training condition was designed to contain relatively less interference demands across trials. Participants are required to remember the same total number of items as in COGENT (i.e., storage requirements were equivalent), but the task contains relatively less interference inherent in the task.
|
|---|---|---|
|
Reading Span fMRI Task
|
.47 score on a scale
Standard Deviation 3.89
|
2.65 score on a scale
Standard Deviation 2.22
|
SECONDARY outcome
Timeframe: Pre to Post Intervention (baseline to week 8)Population: Individuals who did not complete the neurocognitive assessment due to COVID protocols are not included in analyses
The Emotion Regulation task is an assessment of how well participants can modulate their emotions in response to viewing images while undergoing functional MRI. Neural activation to task condition is measured using % signal change (0-100) with higher scores indicating greater activation; change over time will be evaluated.
Outcome measures
| Measure |
COGENT
n=14 Participants
Participants will be Veterans assigned to the active cognitive training (see below for details).
COGENT COGNITIVE TRAINING: Computer-administered cognitive training program. COGENT is a modified working memory capacity task designed to train cognitive functioning. COGENT was designed to contain high interference across trials. By requiring repeated practice with utilization of interference control across trials, COGENT is thought to enhance plasticity of cognitive systems and improve performance. That is, training is based on the premise that learning-based neural changes will occur via repeated exposure to a task demanding cognitive control resources
|
Non-Training
n=11 Participants
Participants will be Veterans assigned to a non-training cognitive program matched for time and memory demands (see below for details).
Non training computer condition: The non-training condition requires participants to complete a similar computer task for the same length of time. The non-training is a modified working memory capacity task designed to be inert. The non-training condition was designed to contain relatively less interference demands across trials. Participants are required to remember the same total number of items as in COGENT (i.e., storage requirements were equivalent), but the task contains relatively less interference inherent in the task.
|
|---|---|---|
|
Emotion Regulation fMRI Task
|
-.01 score on a scale
Standard Deviation .32
|
.06 score on a scale
Standard Deviation .23
|
SECONDARY outcome
Timeframe: Pre to Post Intervention (baseline to week 8)This semi-structured interview is designed to measure posttraumatic stress disorder diagnostic status as well as symptoms severity. Diagnostic status yes/no from the measure will be included as a secondary outcome (i.e., count of individuals with positive diagnosis).
Outcome measures
| Measure |
COGENT
n=42 Participants
Participants will be Veterans assigned to the active cognitive training (see below for details).
COGENT COGNITIVE TRAINING: Computer-administered cognitive training program. COGENT is a modified working memory capacity task designed to train cognitive functioning. COGENT was designed to contain high interference across trials. By requiring repeated practice with utilization of interference control across trials, COGENT is thought to enhance plasticity of cognitive systems and improve performance. That is, training is based on the premise that learning-based neural changes will occur via repeated exposure to a task demanding cognitive control resources
|
Non-Training
n=39 Participants
Participants will be Veterans assigned to a non-training cognitive program matched for time and memory demands (see below for details).
Non training computer condition: The non-training condition requires participants to complete a similar computer task for the same length of time. The non-training is a modified working memory capacity task designed to be inert. The non-training condition was designed to contain relatively less interference demands across trials. Participants are required to remember the same total number of items as in COGENT (i.e., storage requirements were equivalent), but the task contains relatively less interference inherent in the task.
|
|---|---|---|
|
Clinician Administered PTSD Scale Diagnosis
|
21 Participants
|
16 Participants
|
Adverse Events
COGENT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Training
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