DepressionOPTMNCT04010643
Clinical and Economic Evaluation of Neurocognitively-Enhanced Online Cognitive Behavioural Therapy
A study testing online cognitive behavioural therapy and online neurocognitive remediation therapy in people with Depression, run by University of Southern Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- online cognitive behavioural therapy and online neurocognitive remediation therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Oct 2018to 31 Jan 2022
- 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
- scoring a minimum of 14 on the BDI-II,
- internet access
- computer access
- English-speaking fluency
Who cannot join
- scoring less than 14 on BDI
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Depression
- Being tested
- online cognitive behavioural therapy, online neurocognitive remediation therapy
- Keywords
- online cognitive behavioural therapy, online neurocognitive remediation, memory, sustained attention, everyday occupational function, economic evaluation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online cognitive behavioural therapyBehavioural
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 therapyBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| online cognitive behavioural therapy (oCBT) | Active comparator | 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. Receives: Behavioral: online cognitive behavioural therapy |
| online neurocognitively-enhanced CBT (oCBT+oNCRT) | Experimental | 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. Receives: Behavioral: online cognitive behavioural therapy; Behavioral: online neurocognitive remediation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: through study completion, an average of 1 year
Secondary outcomes (8)
Immediate verbal memory (cognitive outcome 1)
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
Measured: through study completion, an average of 1 year
Delayed verbal memory (cognitive outcome 2)
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
Measured: through study completion, an average of 1 year
Inhibition ability (cognitive outcome 3)
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.
Measured: through study completion, an average of 1 year
Flexibility ability (cognitive outcome 4)
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.
Measured: through study completion, an average of 1 year
Verbal working memory (cognitive outcome 5)
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
Measured: through study completion, an average of 1 year
Planning ability (cognitive outcome 6)
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.
Measured: through study completion, an average of 1 year
Work and Social Adjustment (occupational outcome 1)
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.
Measured: through study completion, an average of 1 year
Costs Associated with Mental Healthcare (economic main assessment)
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start24 Oct 2018
- Primary completion31 Jan 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
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.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- 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)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Irish Research Council, Inštitut za ekonomska raziskovanja (Institute for Economic Research, Slovenia), University of Limerick
- Responsible party
- Principal investigator, Maria Semkovska, University of Southern Denmark
- Investigators
- Maria Semkovska, PhD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010643
- Sponsor's protocol ID
- SDU_MS_02
- Acronym
- OPTM
- Status last verified
- Dec 2019
- First submitted
- 22 Jun 2019
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04010643
- Acronym / sponsor ID
- OPTM / SDU_MS_02
- Conditions
- Depression
- Keywords
- online cognitive behavioural therapy, online neurocognitive remediation, memory, sustained attention, everyday occupational function, economic evaluation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Irish Research Council, Inštitut za ekonomska raziskovanja (Institute for Economic Research, Slovenia), University of Limerick
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 8 Jul 2019 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| online cognitive behavioural therapy (oCBT) | Active comparator | Behavioral: online cognitive behavioural therapy20 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) | Experimental | Behavioral: online cognitive behavioural therapy, Behavioral: online neurocognitive remediation therapy20 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- scoring a minimum of 14 on the BDI-II,
- internet access
- computer access
- English-speaking fluency
Key exclusion criteria (1 listed)
- scoring less than 14 on BDI
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 |
|---|---|---|
| online cognitive behavioural therapyoCBT: 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. | Behavioural | online cognitive behavioural therapy (oCBT), online neurocognitively-enhanced CBT (oCBT+oNCRT) |
| online neurocognitive remediation therapyNCRT 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). | Behavioural | online neurocognitively-enhanced CBT (oCBT+oNCRT) |
Primary outcome
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.
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
8 secondary outcomes
Immediate verbal memory (cognitive outcome 1)
Time frame: through study completion, an average of 1 year
Delayed verbal memory (cognitive outcome 2)
Time frame: through study completion, an average of 1 year
Inhibition ability (cognitive outcome 3)
Time frame: through study completion, an average of 1 year
Flexibility ability (cognitive outcome 4)
Time frame: through study completion, an average of 1 year
Verbal working memory (cognitive outcome 5)
Time frame: through study completion, an average of 1 year
Planning ability (cognitive outcome 6)
Time frame: through study completion, an average of 1 year
Work and Social Adjustment (occupational outcome 1)
Time frame: through study completion, an average of 1 year
Costs Associated with Mental Healthcare (economic main assessment)
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Maria Semkovska, PhD principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing online cognitive behavioural therapy and online neurocognitive remediation therapy in people with Depression, run by University of Southern Denmark at 1 site in Denmark.
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 4 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: status not confirmed, as of the sponsor's last update on 18 Dec 2019. 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 Denmark. 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?
Results are not available in the source record.
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?
Depressive symptoms at end of treatment (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 18 Dec 2019.