Action-Based Cognitive Remediation to Improve Vocational Outcomes in Depression (ABCR)
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|ClinicalTrials.gov Identifier: NCT02535390|
Recruitment Status : Completed
First Posted : August 28, 2015
Last Update Posted : November 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Action based cognitive remediation Behavioral: Cognitive remediation||Not Applicable|
Participants will meet with the PI or clinical graduate student to discuss components of cognitive remediation, expectations, and client goals. Follow-up meetings will occur to ensure client satisfaction and determine progress on goal achievement.
Randomization to ABCR or standard CR will be done in groups of 8 to ensure an adequate number of participants in each group. Twenty-four participants will be randomized to each group over the course of the study. Several aspects of the treatments are matched for ideal comparison. Both groups will meet two times per week, two hours per session, for 8 weeks. The same computerized drill and practice, strategic monitoring, and verbal bridging approaches will be used in both groups. The primary differences are the ratio of each aspect of treatment and the manner in which they are bridged work environment. In the standard CR group 60% of the sessions involve computerized drill and practice. In the ABCR group, only 20% of the group sessions are devoted to computer drills, whereas 40% involve the simulated work skills that are directly linked to those computer tasks (see Figure 1 for an example). The remaining 40% of both of the groups involve a didactic component that introduces concepts for that session (e.g., memory strategies, how to avoid distractors), review of homework, and group discussion of bridging. Strategic monitoring occurs during all aspects of treatment, though in ABCR the link between computerized drills and work is made explicit by moving back and forth from computer drills to the role-play tasks. Graduate students in a clinical psychology program who are trained and supervised by Dr. Bowie will conduct the treatment groups. These students will be blind to study hypotheses, though it will not be possible to blind them to the group. Video recordings of sessions are regularly reviewed with Dr. Bowie to ensure treatment fidelity.
In both groups, participants are given the opportunity to engage in supplemental homework exercises outside of the scheduled treatment groups. Scientific Brain Training Pro will be used for computer drills in session and for homework, a program the investigators have used in previous studies. The company provides its software for this research at no cost, but has no input into the design or output of this study. Due to the online availability of the exercises, participants are encouraged to login to the program one or two times per day for 20 minutes each session. Variability in homework completion is expected (and therefore considering it as a treatment process variable and potential mediator of longer-term durability and generalization), yet compliance with the sample is anticipated because they will be engaged standard vocational services programs four days per week, giving them access to an on-site computer room before or after attending their regular appointments.
Few previous studies have examined work stress as a function of supplemental treatments in vocational rehabilitation and to the investigators' knowledge this project will be the first to measure both self-reported and psychophysiological indicators of stress.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Action-Based Cognitive Remediation to Improve Vocational Outcomes in Depression|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||June 1, 2018|
|Actual Study Completion Date :||October 1, 2018|
Experimental: Action based cognitive remediation
Participants in this condition will engage in simulated real world tasks in addition to standard cognitive remediation and group therapy sessions.
Behavioral: Action based cognitive remediation
This is a novel form of cognitive remediation in which participants engage in simulated real world tasks in groups and receive therapist feedback in addition to receiving standard cognitive remediation.
Active Comparator: Standard cognitive remediation
Participants in this condition will engage in computerized cognitive training exercises in addition to standard cognitive remediation and group therapy sessions.
Behavioral: 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.
- Change in composite scores on neurocognitive assessments [ Time Frame: Assessed at baseline, immediately after treatment, and 1 year later ]Assessed with a standardized battery of tests sensitive to cognitive changes. Includes tests measuring domains of attention/vigilance, processing speed, working memory, verbal learning, visual learning, reasoning, and problem solving.
- Change in functional competence [ Time Frame: Assessed at baseline, immediately after treatment, and 1 year later ]Assessed with the UCSD Performance-based Skills Assessment.
- Change in work status [ Time Frame: Assessed at baseline, immediately after treatment, and 1 year later ]Categorical analysis of work/role function: unemployed, part-time, full-time
- Change in everyday real world functioning [ Time Frame: Assessed at baseline, immediately after treatment, and 1 year later ]Assessed with the WHO-DAS
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): NCT02535390
|Kingston, Ontario, Canada, K7L3L3|
|Principal Investigator:||Christopher Bowie, PhD||Queen's University|