Validation of the THINC-it Tool for Cognitive Dysfunction in Major Depressive Disorder

Summary

Cognitive dysfunction is a highly persistent, pervasive and progressive abnormality in young adults (i.e., 18-65 years) with MDD. It has also been shown that among adults with MDD who are gainfully employed, measures of cognition are a greater determinant of overall workplace performance than is total depression symptom severity. Several lines of evidence indicate that cognitive deficits that persist between episodes of depression are critical determinants of functional recovery in the workplace. The functional implications associated with cognitive impairment provide the impetus for systematic evaluation, measurement and assessment of the domains of cognition expected to be impaired in this patient population.

To date, no measurement tool has been sufficiently validated and/or determined to be sensitive to the cognitive deficits in younger adults with MDD. Major limitations of available comprehensive psychometric tools include relative lack of availability, cost, lack of access to most healthcare providers, and above all else, the lengthy time to administer. Moreover, the need for a psychometrist to interpret the results adds to the complexity and the costliness of such an endeavor.

It is imperative that any tool recommended for clinical utility be aligned with the busy nature of a high-volume clinical practice. The ideal gold standard tool for assessing the presence of cognitive dysfunction in MDD in the clinical environment should include, but not be limited to, features such as good conceptual coverage of cognitive domains affected in MDD, good sensitivity and reliability, and it should be relatively uninfluenced by culture effects and practice effects. The tool would also need to be brief, easy to administer and interpret, and complement busy clinical practice.

This study is designed to validate a brief user-friendly tool capable of detecting deficit in cognitive performance among adults with MDD. Data will be gathered with the aim to determine whether the proposed tool identifies cognitive deficits in adults with MDD and differentiates the clinical MDD population from healthy controls.

It is anticipated that the THINC-it tool will be free of charge and downloadable from the THINC-it website for use in the primary care and specialty setting. The THINC-it tool will be accessible via computers/tablets, will take 20 minutes to self-administer in a clinical setting, and the performance results will be immediately available.

Conditions

• Major Depressive Disorder

Interventions

OTHER

THINC-it Tool

Digitalized cognitive test application administering the following cognitive test components: * Digit Symbol Substitution Test (DSST) * Choice Reaction Time (CRT) * One-back working memory tool * Trail Making Test B (TMT-B) * Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)

OTHER

Pencil-and-paper Cognitive Tests

Pencil-and-paper versions of the following cognitive tests: * Digit Symbol Substitution Test (DSST) * Trail Making Test B (TMT-B) * Perceived Deficits Questionnaire-5 Depression (PDQ-5-D) * Variant of Choice Reaction Time (CRT) * Variant of the One-back working memory tool

Sponsors & Collaborators

• Co-Principal Investigators: Dr. Roger S. McIntyre & Dr. John Harrison

  collaborator UNKNOWN

• Imperial College London

  collaborator OTHER

• Brain and Cognition Discovery Foundation

  lead OTHER

Principal Investigators

• Roger McIntyre · Brain and Cognition Discovery Foundation

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-11-30

Primary Completion

2016-07-31

Completion

2016-07-31

Countries

• Canada

Study Locations