Clinical trial NCT04383509: Electroconvulsive Treatment Followed by Cognitive Control Training
Official title: Cognitive Remediation Following Electroconvulsive Therapy in Patients With Treatment Resistant Depression: Randomized Controlled Trail of an Intervention for Relapse Prevention
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depressive Episode
Electroconvulsive Therapy
Cognitive Remediation
Keywords: Cognitive control training
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: University Hospital, Ghent
name: King Baudouin Foundation
First posted: 2020-05-12
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to either intervention or placebo.
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in severity of depressive symptoms, clinician-rated (HAM-D)
timeFrame: 1-7 days before first ECT session, 1-7 days post ECT completion, 1-7 days after intervention/placebo completion, 3 months after ECT completion, and 6 months after ECT completion
measure: Change in severity of depressive symptoms, self-reported (BDI-II)
timeFrame: 1-7 days before first ECT session, 1-7 days post ECT completion, 1-7 days after intervention/placebo completion, 3 months after ECT completion, and 6 months after ECT completion
measure: Change in depressive symptoms and quality of life, self-reported (RDQ)
timeFrame: 1-7 days before first ECT session, 1-7 days post ECT completion, 1-7 days after intervention/placebo completion, 3 months after ECT completion, and 6 months after ECT completion
Secondary outcomes:
measure: Subjective memory complaints (SSMQ)
timeFrame: 1-7 days before first ECT session, 1-7 days post ECT completion, 1-7 days after intervention/placebo completion, 3 months after ECT completion, and 6 months after ECT completion
measure: Quality of Life in Depression Scale (QLDS)
timeFrame: 1-7 days before first ECT session, 1-7 days post ECT completion, 1-7 days after intervention/placebo completion, 3 months after ECT completion, and 6 months after ECT completion
measure: Rumination (RRS-10)
timeFrame: 1-7 days before first ECT session, 1-7 days post ECT completion, 1-7 days after intervention/placebo completion, 3 months after ECT completion, and 6 months after ECT completion
measure: Cognition (CANTAB)
timeFrame: 1-7 days before first ECT session, 1-7 days post ECT completion, 1-7 days after intervention/placebo completion, 3 months after ECT completion, and 6 months after ECT completion
measure: Cognition (Paced Auditory Serial Addition Task - PASAT)
timeFrame: 1-7 days before first ECT session, 1-7 days post ECT completion, 1-7 days after intervention/placebo completion, 3 months after ECT completion and 6 months after ECT completion
measure: Acceptability and satisfaction: Qualitative interviews
timeFrame: 1 - 30 days after CCT training completion
measure: Time to relapse
timeFrame: Up to 6 months monitoring
measure: Facial features from video footage
timeFrame: 2 weeks during CCT or placebo intervention
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: UZ Gent (University Hospital Ghent)
Study officials:
affiliation: University Hospital, Ghent
name: Gilbert Lemmens
role: STUDY_DIRECTOR
affiliation: University Hospital, Ghent
name: Marie-Ann Vanderhasselt
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van de Velde N, Kappen M, Koster EHW, Hoorelbeke K, Tandt H, Verslype P, Baeken C, De Raedt R, Lemmens G, Vanderhasselt MA. Cognitive remediation following electroconvulsive therapy in patients with treatment resistant depression: randomized controlled trail of an intervention for relapse prevention - study protocol. BMC Psychiatry. 2020 Sep 16;20(1):453. doi: 10.1186/s12888-020-02856-x.