Clinical and Economic Evaluation of Neurocognitively-Enhanced Online Cognitive Behavioural Therapy
- Conditions
- Depression
- Interventions
- Behavioral: online cognitive behavioural therapyBehavioral: online neurocognitive remediation therapy
- Registration Number
- NCT04010643
- Lead Sponsor
- University of Southern Denmark
- 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.
- Detailed Description
Depression is the most prevalent mental disorder with high relapse rates. Direct costs to Europe represent 1% of its total economy. Following usual treatment, mood improves or fully recovers but cognitive deficits often persist, preventing full return to normal social function. These deficits worsen with repeated depressive episodes and are a significant predictor of relapse. Preventing depression relapse remains one of the biggest therapeutic challenges in the field. While effective short-term therapies, such as cognitive behavioural therapy (CBT), exist, all are associated with high relapse rates. Online neurocognitive remediation therapy (oNCRT), by its potential to rehabilitate impaired cognition in depression, offers an innovative solution to this mental health problem.
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 134
- scoring a minimum of 14 on the BDI-II,
- internet access
- computer access
- English-speaking fluency
- scoring less than 14 on BDI
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description online neurocognitively-enhanced CBT (oCBT+oNCRT) online neurocognitive remediation therapy 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) online cognitive behavioural therapy 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 neurocognitively-enhanced CBT (oCBT+oNCRT) online cognitive behavioural therapy 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.
- Primary Outcome Measures
Name Time Method Depressive symptoms at end of treatment through study completion, an average of 1 year 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.
Relapse rates at 6 months follow-up through study completion, an average of 1 year 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
- Secondary Outcome Measures
Name Time Method Verbal working memory (cognitive outcome 5) through study completion, an average of 1 year The Digit Span Backwards neuropsychological test is used to assess verbal working memory. It requires the individual to repeat in reverse order a sequence of numbers. The length of the sequence increases after every second trial. The score range is 0 to 16, with higher scores meaning better verbal working memory
Planning ability (cognitive outcome 6) through study completion, an average of 1 year The Towers neuropsychological test is used to assess planning ability. It requires solving problems of increasing difficulty that involve the reproduction of tower models given a specific set of rules. The score range is 0 to 22, with higher scores meaning better planning ability.
Work and Social Adjustment (occupational outcome 1) through study completion, an average of 1 year will be measured with the Work and Social Adjustment Scale, a 5-item self-report questionnaire assessing the impact of depression on current everyday occupational functioning (Mundt et al., 2002). The score range is 0 to 40, with higher scores meaning lower quality of occupational functioning.
Inhibition ability (cognitive outcome 3) through study completion, an average of 1 year will be assessed with the Colour Word Interference Test, a standardized neuropsychological test which third part is designed to assess the individual's ability to inhibit a predominant response (reading a meaningful word) and provide a required response (naming the ink in which a word is printed). Speed of performance (in seconds) at the third part of the test is used to determine inhibition ability, with longer time taken to complete task meaning lower performance.
Immediate verbal memory (cognitive outcome 1) through study completion, an average of 1 year will be assessed with the Logical Memory, a standardized neuropsychological test assessing the ability to recall two stories that one has just heard (Lezak et al., 2012) and after a delay. The first part (Logical memory I) measures immediate verbal memory, with total score ranging 0 to 75, with higher values suggesting better memory
Flexibility ability (cognitive outcome 4) through study completion, an average of 1 year will be assessed with the Colour Word Interference Test, a standardized neuropsychological test which forth part is designed to assess the individual's ability to flexibly shift between a predominant response (reading a meaningful word) and a non dominant required response (naming the ink in which a word is printed). Speed of performance (in seconds) at the forth part of the test is used to determine flexibility ability, with longer time taken to complete task meaning lower performance.
Costs Associated with Mental Healthcare (economic main assessment) through study completion, an average of 1 year Costs Associated with Mental Healthcare Questionnaire, A questionnaire designed to collect data regarding the costs of depression across areas including medication, hospitalisations,consultations with mental healthcare specialists, travel, time away from work etc.; higher values of all items indicate higher costs
Delayed verbal memory (cognitive outcome 2) through study completion, an average of 1 year will be assessed with the Logical Memory, a standardized neuropsychological test assessing the ability to recall two stories that one has just heard (Lezak et al., 2012) and after a delay. The first part (Logical memory II) measures delayed verbal memory, with total score ranging 0 to 50, with higher values suggesting better memory
Trial Locations
- Locations (1)
University of Southern Denmark
🇩🇰Odense, Denmark