Clinical and Economic Evaluation of Neurocognitively-Enhanced Online Cognitive Behavioural Therapy
OPTM
1 other identifier
interventional
134
1 country
1
Brief Summary
To evaluate the clinical efficacy of online cognitive behavioural therapy supplemented with online neurocognitive remediation therapy to improve mood and cognition, decrease relapse rates and optimise work and occupational functioning.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable depression
Started Oct 2018
Typical duration for not_applicable depression
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
October 24, 2018
CompletedFirst Submitted
Initial submission to the registry
June 22, 2019
CompletedFirst Posted
Study publicly available on registry
July 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedDecember 18, 2019
December 1, 2019
2.3 years
June 22, 2019
December 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Depressive symptoms at end of treatment
The Beck's Inventory for Depression - II (BDI-II; Beck et al., 1996) assesses the self-report severity of currently experienced depressive symptoms. The total score of 21 items is used.The scale score ranges 0 to 63, with higher values indicating more severe depression. Scores are to be interpreted as follows: 0-8: no depression; 9-13: subsyndromal depressive symptoms; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression.
through study completion, an average of 1 year
Relapse rates at 6 months follow-up
Percent individuals, whose Beck's Inventory for Depression - II score at end of treatment was below 14, but returned to above 14 at 6-months follow-up
through study completion, an average of 1 year
Secondary Outcomes (8)
Immediate verbal memory (cognitive outcome 1)
through study completion, an average of 1 year
Delayed verbal memory (cognitive outcome 2)
through study completion, an average of 1 year
Inhibition ability (cognitive outcome 3)
through study completion, an average of 1 year
Flexibility ability (cognitive outcome 4)
through study completion, an average of 1 year
Verbal working memory (cognitive outcome 5)
through study completion, an average of 1 year
- +3 more secondary outcomes
Other Outcomes (2)
Work Productivity and the Activity (occupational outcome 2)
through study completion, an average of 1 year
Health-Related Quality of Life (Economic outcome 2): EQ-5D-5L
through study completion, an average of 1 year
Study Arms (2)
online cognitive behavioural therapy (oCBT)
ACTIVE COMPARATOR20 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 neurocognitively-enhanced CBT (oCBT+oNCRT)
EXPERIMENTAL20 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.
Interventions
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.
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
You may qualify if:
- scoring a minimum of 14 on the BDI-II,
- internet access
- computer access
- English-speaking fluency
You may not qualify if:
- scoring less than 14 on BDI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Southern Denmark
Odense, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Semkovska, PhD
University of Southern Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator of OPTM Study
Study Record Dates
First Submitted
June 22, 2019
First Posted
July 8, 2019
Study Start
October 24, 2018
Primary Completion
January 31, 2021
Study Completion
January 31, 2022
Last Updated
December 18, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share