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

University of Southern Denmark (SDU)

Status: Unknown

Conditions: Depression

Treatments: Behavioral: online cognitive behavioural therapy; Behavioral: online neurocognitive remediation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04010643

SDU_MS_02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

online cognitive behavioural therapy (oCBT)

Active Comparator group

Description:

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.

Treatment:

Behavioral: online cognitive behavioural therapy

online neurocognitively-enhanced CBT (oCBT+oNCRT)

Experimental group

Description:

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.

Treatment:

Behavioral: online cognitive behavioural therapy

Behavioral: online neurocognitive remediation therapy