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Clinical and Economic Evaluation of Neurocognitively-Enhanced Online Cognitive Behavioural Therapy (OPTM)

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ClinicalTrials.gov Identifier: NCT04010643
Recruitment Status : Active, not recruiting
First Posted : July 8, 2019
Last Update Posted : December 18, 2019
Sponsor:
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Irish Research Council
Inštitut za ekonomska raziskovanja (Institute for Economic Research, Slovenia)
University of Limerick
Information provided by (Responsible Party):
Maria Semkovska, 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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: online cognitive behavioural therapy Behavioral: online neurocognitive remediation therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study will be a two-group parallel-design randomised controlled trial comparing online cognitive behavioural therapy (oCBT) to oCBT enhanced with neurocognitive remediation for depression
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical and Economic Evaluation of Neurocognitively-Enhanced Online Cognitive Behavioural Therapy to Promote Functional Recovery Among Community-Living Individuals With Depression: OPTM Study (Online Psychological Treatments for Low Mood)
Actual Study Start Date : October 24, 2018
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.

Behavioral: 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.

Experimental: 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.

Behavioral: 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.

Behavioral: 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).




Primary Outcome Measures :
  1. Depressive symptoms at end of treatment [ Time Frame: 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.

  2. Relapse rates at 6 months follow-up [ Time Frame: 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 :
  1. Immediate verbal memory (cognitive outcome 1) [ Time Frame: 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

  2. Delayed verbal memory (cognitive outcome 2) [ Time Frame: 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

  3. Inhibition ability (cognitive outcome 3) [ Time Frame: 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.

  4. Flexibility ability (cognitive outcome 4) [ Time Frame: 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.

  5. Verbal working memory (cognitive outcome 5) [ Time Frame: 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

  6. Planning ability (cognitive outcome 6) [ Time Frame: 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.

  7. Work and Social Adjustment (occupational outcome 1) [ Time Frame: 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.

  8. Costs Associated with Mental Healthcare (economic main assessment) [ Time Frame: 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


Other Outcome Measures:
  1. Work Productivity and the Activity (occupational outcome 2) [ Time Frame: through study completion, an average of 1 year ]
    will be measured with the Work Productivity and Activity Impairment Scale, a 6-item self-report questionnaire (Reilly et al., 1993). Each item, with ranges 0 to 10 will be analysed separately, with higher values representing lower work productivity

  2. Health-Related Quality of Life (Economic outcome 2): EQ-5D-5L [ Time Frame: through study completion, an average of 1 year ]
    will be measured with the EQ-5D-5L self-report questionnaire regarding areas of mobility, self-care, usual activities, pain/discomfort, anxiety. Responses allow for the calculation of quality adjusted life years that are used to inform economic evaluations of healthcare (EuroQol Group, 1990), with scores varying from 0 to 25, with higher values meaning lower quality of life



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • scoring a minimum of 14 on the BDI-II,
  • internet access
  • computer access
  • English-speaking fluency

Exclusion Criteria:

  • scoring less than 14 on BDI

Information from the National Library of Medicine

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): NCT04010643


Locations
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Denmark
University of Southern Denmark
Odense, Denmark
Sponsors and Collaborators
University of Southern Denmark
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Irish Research Council
Inštitut za ekonomska raziskovanja (Institute for Economic Research, Slovenia)
University of Limerick
Investigators
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Principal Investigator: Maria Semkovska, PhD University of Southern Denmark
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Responsible Party: Maria Semkovska, Principal Investigator of OPTM Study, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT04010643    
Other Study ID Numbers: SDU_MS_02
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Semkovska, University of Southern Denmark:
online cognitive behavioural therapy
online neurocognitive remediation
memory
sustained attention
everyday occupational function
economic evaluation
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms