Evaluating cognitive effort in a randomized controlled trial

Turner, Travis H.; Renfroe, Jenna B.; Morella, Kristen; Marriott, Bernadette P.

doi:10.1002/mpr.1505

Cited by 2 publications

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“…We previously reported on the use of embedded indices from a test of sustained attention and inhibition to detect insufficient effort in a clinical trial of omega-3 supplementation for individuals at elevated risk for suicide. 6 Here, 12% of the sample were flagged as giving poor effort on testing using empirically based cutoffs. More recently, we conducted the Ranger Resilience and Improved Performance on Phospholipid bound Omega-3's study (RRIPP-3), a randomized controlled trial (RCT) of omega-3 supplementation from krill oil on cognition and resilience among young military officers.…”

Section: Introductionmentioning

confidence: 99%

Poor effort on cognitive testing in voluntary research predicts failure in US Army Ranger School: Implications for clinical trial design

2023

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Introduction Failure to provide effortful performance on cognitive testing is not uncommon for participants in clinical trials and can significantly impact sensitivity to treatment effect. Whether poor effort on cognitive testing might relate to other behaviors of interest is unknown. In the current investigation, we examined whether effort on baseline cognitive testing in a randomized controlled trial to enhance resiliency in US Army Officers predicted subsequent success in Ranger school. Methods Baseline data on six cognitive tests were obtained from 237 US Army Officers entering a military training program prior to attempting Ranger School. Participation was voluntary and the Army was not informed of test scores. “Poor effort” was defined by chance-level accuracy or extreme outlier scores. Logistic regression examined likelihood of Ranger success according to the number of tests with poor effort. Results Overall, 170 (72%) participants provided good effort on all tests. For these participants, 47% were successful in Ranger, versus 32% with poor effort on one test and 14% with poor effort on two tests. Logistic regression analysis found poor effort on baseline testing predicted reduced likelihood of Ranger success, β =−.486, p = .005. Discussion A substantial number of participants exhibited poor effort on testing, and poor effort was predictive of failure in Ranger school. Findings highlight the importance of assessing effort in clinical trials involving cognitive outcomes and suggest application of cognitive effort testing in trials where other motivated behavior is targeted. Registration Clinical Trials.gov NCT02908932.

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Section: Introductionmentioning

confidence: 99%

Poor effort on cognitive testing in voluntary research predicts failure in US Army Ranger School: Implications for clinical trial design

2023

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Impact of Fatty Acid Supplementation on Cognitive Performance among United States (US) Military Officers: The Ranger Resilience and Improved Performance on Phospholipid-Bound Omega-3’s (RRIPP-3) Study

Marriott

Turner

Hibbeln³

et al. 2021

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Studies have assessed omega-3 fatty acids and cognitive decline among older adults and cognitive development among children, although less is known about cognitive or neurological effects among young adults. We examined whether omega-3 supplementation from krill oil could improve cognition and resilience among young military officers compared to a control. This double-blind, placebo-controlled trial enrolled 555 officers (mean age 23.4 ± 2.8, 98.6% male) entering the United States (US) Army Infantry Basic Officer Leaders Course (IBOLC) with the intention to complete the US Ranger Course. Volunteer participants consumed eight dietary supplements daily of krill oil containing 2.3 g omega-3 or control (macadamia nut oil) over an approximate 20-week period. Cognitive functioning, resilience, and mood were assessed during a well-rested period at approximately 14 weeks and after a battlefield simulation at 16 weeks. Blood spot samples were collected to monitor compliance and dietary intake was assessed. All hypotheses were tested using both ‘Intention to Treat’ (ITT) and ‘As Per Protocol’ (APP) approaches. Of the 555 randomized individuals, 245 (44.1%) completed the study. No statistically significant group-by-time interactions indicating treatment effect were found on any outcomes. Poor compliance was indicated by lower than expected omega-3 elevations in the treatment group, and may have contributed to a failure to detect a response.

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Evaluating cognitive effort in a randomized controlled trial

Cited by 2 publications

References 13 publications

Poor effort on cognitive testing in voluntary research predicts failure in US Army Ranger School: Implications for clinical trial design

Poor effort on cognitive testing in voluntary research predicts failure in US Army Ranger School: Implications for clinical trial design

Impact of Fatty Acid Supplementation on Cognitive Performance among United States (US) Military Officers: The Ranger Resilience and Improved Performance on Phospholipid-Bound Omega-3’s (RRIPP-3) Study

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