Cognitive Enhancement in Recurrent Depression (The COG-D-R Study)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorVanderbilt University Medical Center
About this trial
The goal of this clinical trial is to learn if a combination of non-drug treatments works to benefit memory, thinking, and brain functioning in older individuals with recurrent depression. The non-drug approaches the investigators are studying include transcranial direct current stimulation (tDCS) and computerized cognitive training. tDCS uses small currents of electricity on the forehead to potentially stimulate your brain's ability to process and learn. Computerized cognitive training uses tablet games to improve memory and thinking.
In this study, two different cognitive training programs are being investigated, both of which are stimulating and designed to engage brain activity. One that is believed to be a specific treatment for depression, while the other provides extra stimulation for the brain that is non-specific. Two different tDCS parameters - active stimulation and sham (or placebo) stimulation - are also being investigated.
Participants will be randomized to one of three study groups:
1. Depression cognitive training treatment with active brain stimulation 2. Depression cognitive training treatment with sham brain stimulation 3. Non-specific cognitive training treatment with sham brain stimulation
The main questions this clinical trial aims to answer are:
* Does "depression cognitive training treatment with active brain stimulation" benefit thinking and memory more so than the other treatments? * Does "depression cognitive training treatment with active brain stimulation" benefit brain functioning more so than the other treatments?
Participants will:
* Complete several baseline and post-intervention visits at the research center for checkups and tests over the course of 3-4 months. * Visit the research center daily for 4 weeks to complete their assigned treatment.
Eligibility criteria
Qualifiers
Age > 60 years
Evidence of executive dysfunction via SUBJECTIVE COMPLAINTS (At least one subdomain of the Behavior Rating Inventory of Executive Function in Adults (BRIEF-A) at T > 65, or At least one average score of > 1.5 on Planning, Organization, or Attention subdomains of the Everyday Cognition Scale (ECog)) or OBJECTIVE PERFORMANCE (At least one demographically adjusted z-score > -1.0 SD below the mean on a measure of executive functioning (Digits backward, Trails B, or total Verbal Fluency) on the National Alzheimer's Coordinating Center (NACC) Uniform Data Set 3.0).
DSM-5 diagnosis of a current or past (within last 3 years) depressive episode (e.g., Major Depressive Disorder (MDD), Persistent Depressive Disorder (PDD)) via the using the Structured Clinical Interview for DSM-5 Disorders (SCID-5).
Presence of 2 or more lifetime depressive episodes to be considered "recurrent."
Disqualifiers
Other psychiatric conditions via the SCID-5 (including history of bipolar disorder and psychosis, excluding comorbid anxiety disorders)
Severe depression (MADRS score > 29)
Acute suicidality on clinical evaluation by study clinician and via response on MADRS item 10 (score of 4 or more would require further assessment)
Acute grief (occurring within past month)
Trial design
Treatments tested in this trial
- Depression Cognitive Training
- Non-Specific Cognitive Training
- tDCS (active stimulation)
- tDCS (sham stimulation)
Treatment groups
69 Participants
are divided into 3 treatment groupsSponsors and collaborators
Vanderbilt University Medical Center
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov