Cognitive Remediation Following Electroconvulsive Therapy in Patients With Treatment Resistant Depression: Randomized Controlled Trail of an Intervention for Relapse Prevention
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depressive Episode
- Sponsor
- University Hospital, Ghent
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Change in severity of depressive symptoms, clinician-rated (HAM-D)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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 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.
Investigators
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 MOCA \< 18
- •catatonia
- •schizophrenia
- •alcohol use disorder in previous year
- •prior ECT treatment
- •insufficient computer knowledge or analphabetism
Outcomes
Primary Outcomes
Change in severity of depressive symptoms, clinician-rated (HAM-D)
Time Frame: 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
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.
Change in depressive symptoms and quality of life, self-reported (RDQ)
Time Frame: 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
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.
Change in severity of depressive symptoms, self-reported (BDI-II)
Time Frame: 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
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.
Secondary Outcomes
- Time to relapse(Up to 6 months monitoring)
- 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)
- Facial features from video footage(2 weeks during CCT or placebo intervention)
- 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)
- Acceptability and satisfaction(1 - 30 days after CCT training completion)
- 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)