Trial Outcomes & Findings for GAME Veterans With PTSD Using Computer-Based Cognitive Training (NCT NCT01087775)

Last Updated: 2019-12-23

Results Overview

We presented change scores (6-month scores minus baseline scores) outcomes of 10 measures of neurocognitive measures (together with ranges): the Wechsler Memory Scale (WMS-IV) Paired Associates immediate and delayed memory (range: 1-19), Rey Auditory Verbal Learning Test (RAVLT) total score (range: 0-100) and delayed score (range: 0-20), Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span (range: 0-48), Wechsler Adult Intelligence Scale (WAIS-IV) Letter Number Sequencing (range: 1-19), Auditory Consonant Trigrams (ACT) raw score (range: 0-60), Delis-Kaplan Executive Function System (D-KEFS) Stroop Inhibition (range: 1-19), and the Brief Visual Memory Test revised (BVMT-R) total T score and Delayed T score (range: 20-80). Higher scores mean better cognitive functioning outcomes.

Recruitment status

COMPLETED

Study phase

Target enrollment

25 participants

Primary outcome timeframe

6-month follow-up

Results posted on

2019-12-23

Participant Flow

Recruitment flyers were posted on poster boards and electronic billboards around the SFVAMC; collaborated with other investigators to refer potential participants; utilized social media and created a website. We targeted community-based VA facilities, other Veteran community based organizations and local colleges and universities.

Participant milestones

Participant milestones
Measure	Cognitive Training Plasticity Based Adaptive Cognitive Remediation (PACR) Cognitive Training: Plasticity Based Adaptive Cognitive Remediation (PACR)
Overall Study STARTED	25
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Cognitive Training Plasticity Based Adaptive Cognitive Remediation (PACR) Cognitive Training: Plasticity Based Adaptive Cognitive Remediation (PACR)
Overall Study failed inclusion criteria	2

Baseline Characteristics

GAME Veterans With PTSD Using Computer-Based Cognitive Training

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive Training n=25 Participants Plasticity Based Adaptive Cognitive Remediation (PACR) Cognitive Training: Plasticity Based Adaptive Cognitive Remediation (PACR)
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	32.73 years STANDARD_DEVIATION 6.91 • n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	22 Participants n=93 Participants
Region of Enrollment United States	25 participants n=93 Participants

PRIMARY outcome

Timeframe: 6-month follow-up

Population: Challenges in recruitment/retention led us to redesign the study as an open trial and the limitation is that there is a small number of subjects who completed the study.

Outcome measures

Outcome measures
Measure	Treatment n=7 Participants Treatment Arm
Change Scores of Standard (Untrained) Neurocognitive Measures (Verbal Memory, Learning and Sustained Attention) RAVLT Total raw score	0.71 score on a scale Interval -4.0 to 7.0
Change Scores of Standard (Untrained) Neurocognitive Measures (Verbal Memory, Learning and Sustained Attention) RAVLT Delayed raw score	0.14 score on a scale Interval -3.0 to 3.0
Change Scores of Standard (Untrained) Neurocognitive Measures (Verbal Memory, Learning and Sustained Attention) WMS-IV Digit Span Scaled score	2.43 score on a scale Interval 0.0 to 4.0
Change Scores of Standard (Untrained) Neurocognitive Measures (Verbal Memory, Learning and Sustained Attention) WMS-IV Paired Associates Scaled score	2.29 score on a scale Interval -1.0 to 6.0
Change Scores of Standard (Untrained) Neurocognitive Measures (Verbal Memory, Learning and Sustained Attention) WMS-IV Paired Associates Delayed Scaled score	2.29 score on a scale Interval 0.0 to 6.0
Change Scores of Standard (Untrained) Neurocognitive Measures (Verbal Memory, Learning and Sustained Attention) WMS-IV Letter Number Sequencing scaled score	0.286 score on a scale Interval -1.0 to 2.0
Change Scores of Standard (Untrained) Neurocognitive Measures (Verbal Memory, Learning and Sustained Attention) ACT Raw score	10.57 score on a scale Interval 0.0 to 30.0
Change Scores of Standard (Untrained) Neurocognitive Measures (Verbal Memory, Learning and Sustained Attention) D-KEFS Stroop Inhibition Standard score	2.71 score on a scale Interval 0.0 to 9.0
Change Scores of Standard (Untrained) Neurocognitive Measures (Verbal Memory, Learning and Sustained Attention) BVMT Total T score	0.71 score on a scale Interval -19.0 to 29.0
Change Scores of Standard (Untrained) Neurocognitive Measures (Verbal Memory, Learning and Sustained Attention) BVMT Delayed T score	7 score on a scale Interval -15.0 to 34.0

SECONDARY outcome

Timeframe: 6 month follow-up

Population: Challenges in recruitment/retention led us to redesign the study as an open trial and the limitation is that there is a small number of subjects who completed the study.

To measure social and occupational functioning, we used the World Health Organisation Quality of Life Assessment (WHOQOL-BREF) validated to detect intervention-related change in quality of life. Range of post-treatment domain scores: WHOQOL physical domain: 7-35; WHOQOL psychological domain: 6-30; WHOQOL social relationships domain: 2-10; WHOQOL environment domain: 8-40. Higher scores indicate better quality of life outcomes.

Outcome measures

Outcome measures
Measure	Treatment n=7 Participants Treatment Arm
Social and Occupational Functioning and Quality of Life Scores at 6 Months WHOQOL physical domain score	12.65 score on a scale Standard Deviation 2.75
Social and Occupational Functioning and Quality of Life Scores at 6 Months WHOQOL psychological domain score	10.10 score on a scale Standard Deviation 2.29
Social and Occupational Functioning and Quality of Life Scores at 6 Months WHOQOL social relationships domain score	12.76 score on a scale Standard Deviation 3.16
Social and Occupational Functioning and Quality of Life Scores at 6 Months WHOQOL environment domain score	14.00 score on a scale Standard Deviation 2.75

Adverse Events

Cognitive 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

Dr. Karen Seal

San Francisco VA Medical Center

Phone: 4152214810

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place