Electroconvulsive Treatment Followed by Cognitive Control Training (ECT-CCT)

University Ghent

Status: Terminated

Conditions: Electroconvulsive Therapy; Cognitive Remediation; Depressive Episode

Treatments: Behavioral: Cognitive Control Training; Behavioral: Active Control

Study type: Interventional

Funder types: Other

Identifiers

NCT04383509

EC/2017/0970

Details and patient eligibility

About

Major depressive disorder (MDD) is worldwide one of the most prevalent and disabling mental health conditions. Electroconvulsive therapy (ECT) is a safe and effective treatment even though 6-month relapse rates are high. Cognitive side effects of ECT, such as reduced cognitive control, might trigger mechanisms that increase relapse in patients. As such, cognitive control training (CCT) holds promise as a non-pharmacological strategy to improve long-term effects of ECT (i.e., increase remission, and reduce depression relapse).

Full description

Eighty-eight participants aged between 18-70 years with major depressive disorder who start electroconvulsive treatment (ECT) will be included in this randomized controlled trial (RCT). Following (partial) response to ECT treatment (at least a 25% reduction of clinical symptoms), participants will be randomly assigned to a computer based CCT or active placebo control. A first aim of this RCT is to assess the effects of CCT compared to an active placebo condition on depression symptomatology, cognitive complaints, and quality of life. Secondly, participants will be monitored every two weeks for a period of six months following CCT/active placebo, allowing the detection of potential relapse of depression. Thirdly, the investigators will assess participant evaluation of the addition of cognitive remediation to ECT using qualitative interview methods (satisfaction, acceptability and appropriateness). Finally, in order to further advance the understanding of the mechanisms underlying effects of CCT, exploratory analyses may be conducted using facial video footage collected during the CCT/active control phase of the study.

Enrollment: 21 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged between 18 and 70 years old
• current major depressive episode with treatment resistance
• eligibility and consent for ECT treatment
• ability to provide consent to study

Exclusion criteria

• neurodegenerative disorder or Montreal Cognitive Assessment (MOCA) < 18
• catatonia
• schizophrenia
• alcohol use disorder in previous year
• prior ECT treatment
• insufficient computer knowledge or analphabetism

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 2 patient groups

Cognitive control training

Experimental group

Description:

Cognitive Control Training (CCT) makes use of a very basic cognitive task that strongly loads on working memory and cognitive control processes, namely the adaptive Paced Auditory Serial Addition Task (aPASAT) where participants are given a number every 3 seconds and are asked to add the number they just heard with the number they heard before. Task difficulty is modified based on the participants current task performance, allowing training of cognitive control. Participants in the intervention group will start the CCT training after completion of ECT with a maximum time interval of 7 days. Training sessions will be performed on a tablet or computer and participants will complete five sessions per week (20 minutes per session) for a period of two weeks.

Treatment:

Behavioral: Cognitive Control Training

Active Control

Active Comparator group

Description:

Participants in the active control group will start placebo training after completion of ECT with a maximum time interval of 7 days. The placebo task consists of a task similar to the experimental condition but that does not train cognitive control. Prior research confirmed that this condition controls for non-specific effects of the training and motivational issues. Participants will perform the sessions on a tablet or computer and complete five sessions per week (20 minutes per session) for a period of two weeks.

Treatment:

Behavioral: Active Control