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Evaluating cognitive effort in a randomized controlled trial.

Travis H Turner1,2,3, Jenna B Renfroe4, Kristen Morella5

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Summary
This summary is machine-generated.

Many psychiatric clinical trials lack cognitive effort screening, potentially invalidating results. This study found 12% of participants showed poor effort, impacting outcome interpretation.

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Area of Science:

  • Neuroscience
  • Psychiatry
  • Clinical Trials

Background:

  • Cognitive outcome measures are common in neuropsychiatric randomized controlled trials (RCTs).
  • The validity of cognitive data hinges on adequate participant effort during testing.
  • Screening for poor effort is rarely performed, despite known rates of 10-30% in clinical settings.

Purpose of the Study:

  • To evaluate cognitive testing effort in an RCT for omega-3 supplementation in a high-risk psychiatric population.
  • To determine the prevalence of poor effort in this specific RCT context.

Main Methods:

  • An interim analysis of sustained attention measures from the Connors Performance Test (CPT-2) at baseline was conducted.
  • The study included the first 60 participants of the RCT.
  • Previously validated cut-points were used to identify insufficient effort on the CPT-2.

Main Results:

  • At baseline, 12% (7 out of 60) of participants were identified as exhibiting poor effort.
  • Follow-up analyses suggested less psychiatric distress and suicidality in the poor effort group.
  • The likelihood of poor effort in RCT participation appears comparable to clinical settings.

Conclusions:

  • The findings highlight the critical importance of screening cognitive data for effort in RCTs.
  • Reduced psychiatric distress in the poor effort group raises concerns about the interpretation of other cognitive measures.
  • Future research should examine effort at follow-up and its relationship to attrition, adherence, and treatment response.