Clinical trial NCT04010643: Clinical and Economic Evaluation of Neurocognitively-Enhanced Online Cognitive Behavioural Therapy
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: online cognitive behavioural therapy
online neurocognitive remediation
memory
sustained attention
everyday occupational function
economic evaluation
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Irish Research Council
name: Inštitut za ekonomska raziskovanja (Institute for Economic Research, Slovenia)
name: University of Limerick
First posted: 2019-07-08
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Depressive symptoms at end of treatment
timeFrame: through study completion, an average of 1 year
measure: Relapse rates at 6 months follow-up
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Immediate verbal memory (cognitive outcome 1)
timeFrame: through study completion, an average of 1 year
measure: Delayed verbal memory (cognitive outcome 2)
timeFrame: through study completion, an average of 1 year
measure: Inhibition ability (cognitive outcome 3)
timeFrame: through study completion, an average of 1 year
measure: Flexibility ability (cognitive outcome 4)
timeFrame: through study completion, an average of 1 year
measure: Verbal working memory (cognitive outcome 5)
timeFrame: through study completion, an average of 1 year
measure: Planning ability (cognitive outcome 6)
timeFrame: through study completion, an average of 1 year
measure: Work and Social Adjustment (occupational outcome 1)
timeFrame: through study completion, an average of 1 year
measure: Costs Associated with Mental Healthcare (economic main assessment)
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: Work Productivity and the Activity (occupational outcome 2)
timeFrame: through study completion, an average of 1 year
measure: Health-Related Quality of Life (Economic outcome 2): EQ-5D-5L
timeFrame: through study completion, an average of 1 year
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark
Study officials:
affiliation: University of Southern Denmark
name: Maria Semkovska, PhD
role: PRINCIPAL_INVESTIGATOR
References: