Remote Cognitive Remediation for Depression
RECORD
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 24, 2016
CompletedFirst Posted
Study publicly available on registry
April 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedAugust 29, 2018
August 1, 2018
2.6 years
December 24, 2016
August 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in composite neurocognition scores from the CNS Vitals Signs battery
Neurocognitive Measure
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.
Secondary Outcomes (8)
Virtual Reality Functional Capacity Test
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.
Composite neurocognition score from the CNS Vitals Signs battery
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.
World Health Organization Quality of Life
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.
Bell-Lysaker Emotion Recognition Task
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.
Montgomery-Asberg Depression Rating Scale
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.
- +3 more secondary outcomes
Study Arms (3)
Active Cognitive Remediation -Long-term
EXPERIMENTALParticipants 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 Cognitive Remediation -Short-term
ACTIVE COMPARATORParticipants 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.
Cognitive Remediation Control
PLACEBO COMPARATORParticipants 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
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.
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.
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.
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.
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).
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Queen's Universitylead
- Canadian Institutes of Health Research (CIHR)collaborator
Study Sites (1)
Queen's University
Kingston, Ontario, K7L3N6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher R Bowie, Ph D CPsych
Queen's University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 24, 2016
First Posted
April 10, 2018
Study Start
December 1, 2016
Primary Completion
July 1, 2019
Study Completion
January 1, 2020
Last Updated
August 29, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share