Depression Clinical Trial
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.
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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