DepressionABCRNCT02535390
Action-Based Cognitive Remediation to Improve Vocational Outcomes in Depression
A study testing Action based cognitive remediation and Cognitive remediation in people with Depression, run by Queen's University at 1 site in Canada.
Trial summary
Major depressive disorder places a tremendous burden on workplace disability each year. Its diagnosis is based on the presence of characteristic symptoms that include disturbances in mood regulation, maladaptive beliefs, and behaviour. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Action based cognitive remediation and Cognitive remediation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2014to 1 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM Axis 1 Mental disorder of Major Depressive Disorder
- Between the ages of 18 and 65 years old
Who cannot join
- Reading level below grade 6 (assessed with the Wide Range Achievement - Reading Recognition Test)
Trial locations and contacts
1 site in 1 country.
About this study
Major depressive disorder places a tremendous burden on workplace disability each year. Its diagnosis is based on the presence of characteristic symptoms that include disturbances in mood regulation, maladaptive beliefs, and behaviour. Impairment in neurocognitive functions (e.g., information processing speed, attention, memory, problem solving skills) is absent from current diagnostic criteria and off the radar in most clinical treatment settings, yet increasingly recognized as a primary cause of poor work functioning and outcomes. This disconnect between the root causes of poor vocational outcomes and targets of treatment has resulted in a failure to return to work following illness, job underproductivity, and work-related stress, which contribute to indirect costs to society each year. The investigators seek to expand scientific support for treating neurocognitive impairments in order to increase occupational productivity and reduce job-related stress associated with depression. The investigators developed a novel group cognitive remediation (CR) treatment, Action-Based Cognitive Remediation (ABCR). It builds on procedural learning skills with explicit work-related role-plays to facilitate immediate and salient abstraction of drill and practice remediation techniques. The activities were developed in collaboration with a community rehabilitation partner in this study through systematic interviews with job placement specialists and supervisors from employment sites used by the agency. The props match those used in work settings and include miniature versions of a cash register, filing system, conveyer belt, cleaning closet, garden nursery, and secretarial station. The activities capitalize on procedural learning skills through roleplays and props that simulate a work environment. ABCR maintains important aspects of drill and practice, strategic monitoring to enhance flexible problem solving approaches, and bridging. The role-plays follow computerized drill and practice exercise and therapists facilitate group discussions of how cognitive skills and flexibility in thinking from drill and practice can be effective while directly engaged in an everyday work environment. Thus, bridging used in ABCR is a tangible, procedural, and realistic. This approach to bridging differentiates the treatment from standard CR, where the discussion-based approach is limited by the auditory learning, memory, and abstraction deficits observed in depression.
Read the detailed description
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.
- Conditions
- Depression
- Being tested
- Action based cognitive remediation, Cognitive remediation
- Keywords
- cognitive remediation, vocational outcomes
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action based cognitive remediationBehavioural
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.
Cognitive remediationBehavioural
Cognitive remediation engages participants in computerized exercises meant to improve cognitive functions and provides therapist feedback for how these improvements manifest in everyday life.
| Study group | Role | What they receive |
|---|---|---|
| Action based cognitive remediation | Experimental | Participants in this condition will engage in simulated real world tasks in addition to standard cognitive remediation and group therapy sessions. Receives: Behavioral: Action based cognitive remediation |
| Standard cognitive remediation | Active comparator | Participants in this condition will engage in computerized cognitive training exercises in addition to standard cognitive remediation and group therapy sessions. Receives: Behavioral: Cognitive remediation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in composite scores on neurocognitive assessments
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.
Measured: Assessed at baseline, immediately after treatment, and 1 year later
Secondary outcomes (3)
Change in functional competence
Assessed with the UCSD Performance-based Skills Assessment.
Measured: Assessed at baseline, immediately after treatment, and 1 year later
Change in work status
Categorical analysis of work/role function: unemployed, part-time, full-time
Measured: Assessed at baseline, immediately after treatment, and 1 year later
Change in everyday real world functioning
Assessed with the WHO-DAS
Measured: Assessed at baseline, immediately after treatment, and 1 year later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startDec 2014
- Primary completion1 Jun 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Dr. Christopher Bowie, Queen's University
- Investigators
- Christopher Bowie, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535390
- Sponsor's protocol ID
- PSYC-152-14
- Acronym
- ABCR
- Status last verified
- Aug 2018
- First submitted
- 20 Apr 2015
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Action-Based Cognitive Remediation to Improve Vocational Outcomes in Depression
- ClinicalTrials.gov ID
- NCT02535390
- Acronym / sponsor ID
- ABCR / PSYC-152-14
- Conditions
- Depression
- Keywords
- cognitive remediation, vocational outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Dec 2014
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 28 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Major depressive disorder places a tremendous burden on workplace disability each year. Its diagnosis is based on the presence of characteristic symptoms that include disturbances in mood regulation, maladaptive beliefs, and behaviour. Impairment in neurocognitive functions (e.g., information processing speed, attention, memory, problem solving skills) is absent from current diagnostic criteria and off the radar in most clinical treatment settings, yet increasingly recognized as a primary cause of poor work functioning and outcomes. This disconnect between the root causes of poor vocational outcomes and targets of treatment has resulted in a failure to return to work following illness, job underproductivity, and work-related stress, which contribute to indirect costs to society each year. The investigators seek to expand scientific support for treating neurocognitive impairments in order to increase occupational productivity and reduce job-related stress associated with depression. The investigators developed a novel group cognitive remediation (CR) treatment, Action-Based Cognitive Remediation (ABCR). It builds on procedural learning skills with explicit work-related role-plays to facilitate immediate and salient abstraction of drill and practice remediation techniques. The activities were developed in collaboration with a community rehabilitation partner in this study through systematic interviews with job placement specialists and supervisors from employment sites used by the agency. The props match those used in work settings and include miniature versions of a cash register, filing system, conveyer belt, cleaning closet, garden nursery, and secretarial station. The activities capitalize on procedural learning skills through roleplays and props that simulate a work environment. ABCR maintains important aspects of drill and practice, strategic monitoring to enhance flexible problem solving approaches, and bridging. The role-plays follow computerized drill and practice exercise and therapists facilitate group discussions of how cognitive skills and flexibility in thinking from drill and practice can be effective while directly engaged in an everyday work environment. Thus, bridging used in ABCR is a tangible, procedural, and realistic. This approach to bridging differentiates the treatment from standard CR, where the discussion-based approach is limited by the auditory learning, memory, and abstraction deficits observed in depression.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Action based cognitive remediation | Experimental | Behavioral: Action based cognitive remediationParticipants in this condition will engage in simulated real world tasks in addition to standard cognitive remediation and group therapy sessions. |
| Standard cognitive remediation | Active comparator | Behavioral: Cognitive remediationParticipants in this condition will engage in computerized cognitive training exercises in addition to standard cognitive remediation and group therapy sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- DSM Axis 1 Mental disorder of Major Depressive Disorder
- Between the ages of 18 and 65 years old
Key exclusion criteria (1 listed)
- Reading level below grade 6 (assessed with the Wide Range Achievement - Reading Recognition Test)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action based cognitive remediationThis 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. | Behavioural | Action based cognitive remediation |
| Cognitive remediationCognitive remediation engages participants in computerized exercises meant to improve cognitive functions and provides therapist feedback for how these improvements manifest in everyday life. | Behavioural | Standard cognitive remediation |
Primary outcome
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.
3 secondary outcomes
Change in functional competence
Time frame: Assessed at baseline, immediately after treatment, and 1 year later
Change in work status
Time frame: Assessed at baseline, immediately after treatment, and 1 year later
Change in everyday real world functioning
Time frame: Assessed at baseline, immediately after treatment, and 1 year later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Bowie, PhD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action based cognitive remediation and Cognitive remediation in people with Depression, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in composite scores on neurocognitive assessments (time frame: Assessed at baseline, immediately after treatment, and 1 year later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.