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Remote Cognitive Remediation for Depression (RECORD)

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ClinicalTrials.gov Identifier: NCT03492203
Recruitment Status : Recruiting
First Posted : April 10, 2018
Last Update Posted : August 29, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr. Christopher Bowie, Queen's University

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.

Condition or disease Intervention/treatment Phase
Major Depression Behavioral: Active Cognitive Remediation Behavioral: Cognitive Remediation Control Behavioral: Online computer exercises Behavioral: Strategy monitoring Behavioral: Bridging strategies Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Remote Cognitive Remediation for Depression
Study Start Date : December 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: 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.

Behavioral: 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.

Behavioral: 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.

Behavioral: 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).

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.
Behavioral: 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.

Behavioral: 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.

Behavioral: 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.

Behavioral: 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).

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.
Behavioral: 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.

Behavioral: 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.

Behavioral: 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.

Behavioral: 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 Measures :
  1. 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. ]
    Neurocognitive Measure


Secondary Outcome Measures :
  1. Virtual Reality Functional Capacity Test [ 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. ]
    Functional Capacity Measure

  2. Composite neurocognition score 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. ]
    Functional Capacity Measure

  3. World Health Organization Quality of Life [ 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. ]
    Everyday Functioning Measure

  4. Bell-Lysaker Emotion Recognition Task [ 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. ]
    Social Cognition Measure

  5. Montgomery-Asberg Depression Rating Scale [ 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. ]
    Mood symptom rating

  6. Sheehan Disability Scale [ 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. ]
    Self-reported quality of life

  7. Lam Employment Absence and Productivity Scale [ 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. ]
    Work outcomes

  8. Need for Cognition Scale [ 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. ]
    Self-reported need for cognitive demand in life



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03492203


Contacts
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Contact: Tammy L Vanrooy, BA Hons Law 613 533 6000 ext 78478 tammy.vanrooy@queensu.ca

Locations
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Canada, Ontario
Queen's University Recruiting
Kingston, Ontario, Canada, K7L3N6
Contact: Tammy Vanrooy, BA Hons Law    613-533-6000 ext 78478    tammy.vanrooy@queensu.ca   
Principal Investigator: Christopher Bowie, PhD, CPsych         
Sponsors and Collaborators
Queen's University
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Christopher R Bowie, Ph D CPsych Queen's University

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Responsible Party: Dr. Christopher Bowie, Professor, Queen's University
ClinicalTrials.gov Identifier: NCT03492203     History of Changes
Other Study ID Numbers: PSYC-189-16
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Christopher Bowie, Queen's University:
Cognitive Remediation
Neurocognition
Severe mental illness
Remote treatment
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders