NCT04383509

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).

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

May 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2023

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

3.1 years

First QC Date

May 7, 2020

Last Update Submit

November 27, 2023

Conditions

Depressive EpisodeElectroconvulsive TherapyCognitive Remediation

Keywords

Cognitive control training

Outcome Measures

Primary Outcomes (3)

  • Change in severity of depressive symptoms, clinician-rated (HAM-D)

    The Hamilton Depression Rating Scale (HAM-D) is a clinician rated questionnaire with 17 items scored on a three or five-point Likert-type scale. Amongst other symptoms of depression, items include mood, insomnia and suicidal ideations. Higher scores indicate increased severity of depression with a maximum score of 50 and minimum of 0.

    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

  • Change in severity of depressive symptoms, self-reported (BDI-II)

    The Beck Depression Inventory (BDI-II) is a 21-item self-report questionnaire regarding symptoms of depression with good validity and reliability. Higher scores indicate increased severity of depression. Minimum score is 0 and 63 is the maximum score.

    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

  • Change in depressive symptoms and quality of life, self-reported (RDQ)

    The Remission from Depression Questionnaire (RDQ) will inform about seven domains: symptoms of depression, non-depressive symptoms, features of positive mental health, coping ability, functioning, life satisfaction and a general sense of well-being. The RDQ is a 41-item questionnaire. Higher scores indicate increased severity of depression. Minimum score is 0 and 82 is the maximum score.

    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 (8)

  • Subjective memory complaints (SSMQ)

    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

  • Quality of Life in Depression Scale (QLDS)

    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

  • Rumination (RRS-10)

    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

  • Cognition (CANTAB)

    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

  • Cognition (Paced Auditory Serial Addition Task - PASAT)

    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

  • +3 more secondary outcomes

Study Arms (2)

Cognitive control training

EXPERIMENTAL

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.

Behavioral: Cognitive Control Training

Active Control

ACTIVE COMPARATOR

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.

Behavioral: Active Control

Interventions

Cognitive Control TrainingBEHAVIORAL

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.

Also known as: aPASAT
Cognitive control training
Active ControlBEHAVIORAL

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.

Active Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Gent (University Hospital Ghent)

Ghent, 9000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 32938410DERIVED

Study Officials

  • Gilbert Lemmens

    University Hospital, Ghent

    STUDY DIRECTOR

  • Marie-Ann Vanderhasselt

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Upon registration in the computer-based training, the computer will randomly allocate participants to either cognitive control training or placebo condition.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be assigned to either intervention or placebo.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2020

First Posted

May 12, 2020

Study Start

May 10, 2020

Primary Completion

June 14, 2023

Study Completion

July 1, 2023

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

The datasets generated and/or analyzed during the current study are not publicly available due to confidentiality issues but are available from the corresponding author upon reasonable request.

Locations

BE(1)