Recruiting

Cognitive Remediation

Sponsor:

Queen's University

Code:

NCT03492203

Conditions

Major Depression

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Active Cognitive Remediation

Cognitive Remediation Control

Online computer exercises

Strategy monitoring

Bridging strategies

Study Details

Brief summary:

Major depressive disorder is the number one cause of disability worldwide. Evidence regarding the effectiveness of various treatments for patients with severe depression is still lacking. Although many patients achieve treatment response, only a minority of patients achieve full remission and even fewer sustain it. In fact, within one month 10% will be re-hospitalized and the rate climbs to 30% within a year. Further, remission from depressive symptoms is a surprisingly poor predictor of recovery of community functioning following discharge. It is clear that the traditional focus on diagnostic symptoms is insufficient for promoting a full return to everyday functioning. The present aim is to examine the efficacy and effectiveness of treating neurocognition, a symptom that explains persistent deficits in community functioning for those with depression. The study design that maps on to the contemporary clinical setting, in order to reflect the changing landscape of inpatient and community treatment.

Conditions

Major Depression

Study ID

NCT03492203

Start date

Dec, 2016

Status verified date

Aug, 2018

Completion date

Jan, 2020

Anticipated

Primary completion date

Jul, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria: Participants must have a primary diagnosis of Major Depressive Disorder

Exclusion Criteria: Medical conditions that affect central nervous system functioning, substance abuse within the past three months (assessed with the SCID-V), and sensory or perceptual conditions that affect validity of testing.

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active Cognitive Remediation -Long-term

Participants in the long-term treatment will receive 24 weeks of active cognitive remediation. Participants will complete 24 weeks of on-line computer exercises and participate in an on-line forum to facilitate strategy monitoring and bridging strategies.

active comparator: Active Cognitive Remediation -Short-term

Participants in the short-term treatment will receive 12 weeks of active cognitive remediation (the standard length of time in the literature). Participants will complete 12 weeks of on-line computer exercises and participate in an on-line forum to facilitate strategy monitoring and bridging strategies.

placebo comparator: Cognitive Remediation Control

Participants in the comparison training group will login to the same training environment but the cognitive load will not adjust as it does in the experimental conditions. Participants in this group will complete 12 weeks of on-line computer exercises.

Interventions

Active Cognitive Remediation

Cognitive remediation engages participants in computerized exercises meant to improve cognitive functions and provides therapist feedback for how these improvements manifest in everyday life. The novel components of CR in this study will be the delivery of treatment remotely.

Cognitive Remediation Control

The investigators have developed a 'comparison' cognitive remediation treatment in collaboration with the same company that produced the cognitive exercises. These procedures include the same stimuli but are adjusted without increasing cognitive load.

Online computer exercises

There are 30 unique cognitive exercises in the program (sbtpro.com). The investigators will prescribe 24 exercises in the domains most commonly impaired in MDD: six targeting executive functions, ten targeting memory, and eight targeting attention and working memory. The specific activities are prescribed in a fixed, systematic order, such that the participants have a schedule of exercises that address several different cognitive domains each week and return to exercises in subsequent weeks. Parameters are automatically adjusted based on participant performance across 30 difficulty levels. Participants are prescribed two 20-minute sessions per day, five days per week, for the duration of the study.

Strategy monitoring

Therapists communicate with participants in asynchronous private and group forums, where specific responses to questions prime flexible strategy formation, monitoring of strategies, and bridging to real world functioning. Participants use logs to track their own strategies and upload this information to the forum for therapist feedback. The purpose of the therapist responses is to reinforce the development of multiple strategies and help supplement or reshape those that are concrete, based on a predetermined list of strategies developed for each of the computer exercises.

Bridging strategies

The online forum will have illustrations for bridging cognitive abilities and problem solving strategies related to each game to experiences in the real world. An at home workbook will also be used to facilitate active application of skills in various domains (e.g., work, socialization, recreation, household maintenance).

Primary outcome measure

  • Changes in composite neurocognition scores from the CNS Vitals Signs battery [ Time Frame: Participants will be tested at baseline, and assessed for changes at 12 weeks (post-intervention, intermediate intervention, or sham, respectively), and assessed for changes at 6 months post-intervention. ]

Central Contacts and Locations

Central contacts

Tammy L Vanrooy, BA Hons Law

613 533 6000tammy.vanrooy@queensu.ca

Locations

Queen's University

Recruiting

Kingston, Ontario, Canada, K7L3N6

Contacts

Tammy Vanrooy, BA Hons Law

613-533-6000tammy.vanrooy@queensu.ca

Principal Investigator:

Christopher Bowie, PhD, CPsych

More Information

Sponsor

Queen's University

Last update posted

Aug 29, 2018

Last verified

Aug, 2018

Keywords

  • Cognitive Remediation
  • Neurocognition
  • Severe mental illness
  • Remote treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Queen's University on 2018-08-29.