RCT for Electroconvulsive Treatment Followed by Cognitive Control Training

  • STATUS
    Recruiting
  • End date
    Sep 30, 2025
  • participants needed
    88
  • sponsor
    University Ghent
Updated on 24 January 2021

Summary

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).

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 our 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.

Details
Condition Endogenous depression, Electroconvulsive Therapy, Cognitive Remediation, depressive episode, electroconvulsive therapy (ect)
Treatment Cognitive control training, Active control
Clinical Study IdentifierNCT04383509
SponsorUniversity Ghent
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Gender: Male or Female
Do you have any of these conditions: Endogenous depression or Cognitive Remediation or Electroconvulsive Therapy?
Do you have any of these conditions: Endogenous depression or electroconvulsive therapy (ect) or Cognitive Remediation or depressive episode or Electroconvulsive Therapy?
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
Clear my responses

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