Clinical and Economic Evaluation of Neurocognitively-Enhanced Online Cognitive Behavioural Therapy
NCT ID: NCT04010643
Last Updated: 2019-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
134 participants
INTERVENTIONAL
2018-10-24
2022-01-31
Brief Summary
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Detailed Description
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This trial aims to test the effectiveness and cost-effectiveness of neurocognitively enhanced online CBT to improve mood and cognition in depression, optimise everyday functioning and prevent depression relapse over six months follow-up, using a randomised active-control parallel-groups research design. Individuals presenting with at least mild depression (n=134) are randomly assigned to one of two treatment allocations: online CBT (oCBT) or neurocognitively enhanced online CBT (oCBT+oNCRT) for 20 one-hour sessions over 5 weeks (i.e., four weekly sessions).
Before randomisation and within a week of the final allocated session, mood, attention, memory and planning abilities will be assessed. All participants will be then followed for six-months to determine if the mood and cognitive benefits of the oCBT+oNCRT are maintained with the passage of time compared to the control group (oCBT alone). Standard measures of daily functioning (e.g., work ability, occupational function) and economic cost-effectiveness data will be obtained at the same time points. Demonstrating the oNCRT effectiveness as an adjunct to CBT will contribute towards optimising connected healthcare solutions for depression.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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online cognitive behavioural therapy (oCBT)
20 hours of online engagement with the oCBT programme over 5 weeks, distributed as follows.
Each week, the participants complete 1 hour of of the MoodGym program, followed by 2 hours of practical online CBT homework. To equate time and type of engagement spent in doing oCBT and oCBT+NCRT, 1 final hour per week is dedicated to completing online puzzles.
online cognitive behavioural therapy
oCBT: MoodGym is a 5-week oCBT program developed by the Centre for Mental Health Research at the Australian National University. This program has been shown to be clinically effective at reducing mood symptoms in depression studies (see meta-analytical review of Twomey \& O'Reilly, 2017). MoodGym consists of a number of interactive modules to be completed sequentially and including work on own feelings, thoughts, methods to change dysfunctional thinking patterns, de-stressing, and relaxation. Each module is followed by an associated practical homework, while a personalised workbook allows the participant to track their mood profile and progress throughout the modules.
online neurocognitively-enhanced CBT (oCBT+oNCRT)
20 hours of online engagement with the oCBT+oNCRT programme over 5 weeks, distributed as follows.
Each week, the participants complete 1 hour of the MoodGym program, followed by 1 hour of practical online CBT homework \& 3 hours of the online NCRT programme Cognifit targeting attention, memory, and planning ability.
online cognitive behavioural therapy
oCBT: MoodGym is a 5-week oCBT program developed by the Centre for Mental Health Research at the Australian National University. This program has been shown to be clinically effective at reducing mood symptoms in depression studies (see meta-analytical review of Twomey \& O'Reilly, 2017). MoodGym consists of a number of interactive modules to be completed sequentially and including work on own feelings, thoughts, methods to change dysfunctional thinking patterns, de-stressing, and relaxation. Each module is followed by an associated practical homework, while a personalised workbook allows the participant to track their mood profile and progress throughout the modules.
online neurocognitive remediation therapy
NCRT involves the behavioural application of structured exercises targeting neurocognitive processes by mobilising neuroplasticity that is the brain's ability to adjust its function in response to environmental change. Computerised NCRT has demonstrated efficacy to improve attention, working memory and global functioning in depression (Motter et al., 2016; Semkovska et al., 2015). NCRT is delivered through the Cognifit online programme. The Cognifit modules were selected as targeting remediation of neurocognitive domains known to be impaired in depression, i.e. selective and divided attention, visual and verbal working memory, and everyday planning (Hammar and Ardal, 2009; Semkovska et al., 2019).
Interventions
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online cognitive behavioural therapy
oCBT: MoodGym is a 5-week oCBT program developed by the Centre for Mental Health Research at the Australian National University. This program has been shown to be clinically effective at reducing mood symptoms in depression studies (see meta-analytical review of Twomey \& O'Reilly, 2017). MoodGym consists of a number of interactive modules to be completed sequentially and including work on own feelings, thoughts, methods to change dysfunctional thinking patterns, de-stressing, and relaxation. Each module is followed by an associated practical homework, while a personalised workbook allows the participant to track their mood profile and progress throughout the modules.
online neurocognitive remediation therapy
NCRT involves the behavioural application of structured exercises targeting neurocognitive processes by mobilising neuroplasticity that is the brain's ability to adjust its function in response to environmental change. Computerised NCRT has demonstrated efficacy to improve attention, working memory and global functioning in depression (Motter et al., 2016; Semkovska et al., 2015). NCRT is delivered through the Cognifit online programme. The Cognifit modules were selected as targeting remediation of neurocognitive domains known to be impaired in depression, i.e. selective and divided attention, visual and verbal working memory, and everyday planning (Hammar and Ardal, 2009; Semkovska et al., 2019).
Eligibility Criteria
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Inclusion Criteria
* internet access
* computer access
* English-speaking fluency
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Irish Research Council
OTHER
Inštitut za ekonomska raziskovanja (Institute for Economic Research, Slovenia)
UNKNOWN
University of Limerick
OTHER
University of Southern Denmark
OTHER
Responsible Party
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Maria Semkovska
Principal Investigator of OPTM Study
Principal Investigators
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Maria Semkovska, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Southern Denmark
Locations
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University of Southern Denmark
Odense, , Denmark
Countries
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Other Identifiers
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SDU_MS_02
Identifier Type: -
Identifier Source: org_study_id