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Cognitive Enhancement in Recurrent Depression (The COG-D-R Study)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether brain stimulation and tablet games can help memory, thinking, and brain function. It is for adults over 60 who have had depression more than once and have trouble with thinking skills. The study compares different tablet games with real or pretend brain stimulation, which uses small electric currents on the forehead.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are older than 60.
  • Surveys or tests show trouble with skills like planning, staying organized, or paying attention.
  • A study interview confirms that you have depression now or had it within the past 3 years.
  • You have had at least 2 periods of depression in your life.
  • Your antidepressant treatment has stayed the same for at least 6 weeks, or you are not taking antidepressants. You do not plan to change treatment during the study.
  • You speak English fluently.

Who can't join

  • You have another mental health condition, such as a history of bipolar disorder or psychosis. Anxiety disorders are allowed.
  • You have severe depression, a current risk of suicide, or grief that began within the past month.
  • You have had a moderate or severe alcohol or drug use disorder within the past 12 months.
  • You take medicines that could strongly affect how the brain stimulation works.
  • You have a brain or nerve disorder, such as epilepsy, a brain tumor, Parkinson’s disease, or dementia; a score below 23 on the MoCA thinking test; or mainly memory problems rather than other thinking problems.
  • You have a disability that keeps you from completing tests, an unstable illness needing urgent care, or a condition that makes an MRI scan unsafe.
  • You had ECT (electrical treatment for depression) or TMS (magnetic brain stimulation) within the past 2 months, or you are currently in talk therapy.
  • You are in another research study that gives a treatment. Studies that only observe you are allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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." * Either stable antidepressant regimen for at least 6 weeks or no current antidepressant treatment (no plans to change treatment over course of study). * Fluent in English Exclusion Criteria: * 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) * History of alcohol use disorder or substance use disorder of moderate or greater severity in the last 12 months * Medications that would significantly interfere with tDCS effects (i.e., sodium channel blockers, GABA-ergic or glutamatergic drugs; see Appendix B for exclusionary list)40 * Primary neurological disorder (e.g., epilepsy, brain tumor, Parkinson's disease, Alzheimer's disease, dementia diagnosis) * Montreal Cognitive Assessment (MoCA) \< 23 * Primary amnestic cognitive profile (\>1.5 SD below demographically-adjusted mean on NACC memory measures in context otherwise normal cognitive profile, or per clinician judgement) * Any physical or intellectual disability affecting ability to complete assessments * Unstable medical illness needing urgent treatment * MRI contraindications * Electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) in last 2 months * Current involvement in psychotherapy * Current involvement in other research studies (including but not limited to: neuromodulation \[TMS or tDCS\] or investigational drug studies). Observational studies \[without intervention\] are acceptable.

Study sites (1)

TN