COG-D Study

JOIN THE COG-D STUDY

(COGnitive Enhancement in Depression)

brain

Did you know that older adults with depression may experience memory or thinking (aka ‘cognitive’) changes?

These symptoms we see with depression do not always improve with antidepressant medications or other depression treatments. But these symptoms can cause distress and difficulties with daily activities.

The current study seeks to combine two non-drug interventions (brain stimulation and cognitive training) to see whether they can improve memory and thinking, as well as depressive symptoms, in older adults with recurrent depression.

The non-drug approaches we are investigating include transcranial direct current stimulation (tDCS) and computerized cognitive training. tDCS uses small currents of electricity on your forehead to potentially stimulate your brain’s ability to process and learn. Computerized cognitive training uses computer or tablet games to improve memory and thinking. We also want to determine how tDCS and computerized cognitive training affects brain function in order to cause these changes. To date, there is no medicine or intervention that is approved by the U.S. Food and Drug Administration (FDA) to treat memory and thinking difficulties in depressed adults.

This study will help determine if this combination of treatments should be further studied in recurrent depression. It will also help determine who may be more likely to benefit from combined brain stimulation and cognitive training interventions.

We are seeking adults age 60 or older who:

  • Have a recent history of depression and are noticing mild memory or thinking difficulties

You may be eligible to participate if you:

  • Are 60 years of age or older
  • Have history of depression (2 or more episodes; either current or occurring within past 3 years)
  • Have noticed changes in your memory and / or thinking skills
  • Have no other mental health problems, other than depression and anxiety
  • Have no neurological conditions (including diagnoses of dementia or Alzheimer's disease)
  • Are able to have an MRI scan

Why should I consider participating?

Participants all have unique reasons for joining research studies.

By participating in this study, you are helping us understanding interventions that treat cognitive symptoms in recurrent depression. This study may also inform what we know about depression and how we treat it in the future. You also get to learn more about your depression.

Although we cannot guarantee that you personally will benefit from participating, we try to make sure that all participants have a better understanding of their depression and a plan to help them recover. 

We are dedicated and passionate about our research and could not do it without your help!

What is involved in the study?

First you will have a preliminary telephone call or survey to make sure you are eligible. If you appear eligible and agree to participate, you will complete an initial screening visit to see if you qualify for the study.

The screening visit takes about 3.0 to 3.5 hours and will take place at Vanderbilt University Medical Center (VUMC). This visit will include an interview, some memory and thinking tests, as well as completing questionnaires. 

After you complete the screening process, you will then enter a baseline period. The baseline period will last up to 4 weeks and will include 1 to 2 in-person visits. The total time required to complete the baseline period is about 3.0 to 3.5 hours spread over the multiple visits. During the baseline period, you will complete one Magnetic Resonance Imaging (MRI) brain scan, some additional memory and thinking tests, and additional questionnaires.

You will then enter the intervention phase of the study. This part of the study occurs daily for 1.5 hours over 4 weeks at VUMC. During this period, you will receive brain stimulation while you are completing computerized cognitive training. Note that participants will be randomized to receive either active or sham (i.e., placebo) tDCS and all participants will receive the cognitive training intervention.

After completion of the intervention, you will return to complete questionnaires and memory and thinking testing, and a MRI brain scan.

Three months after you complete the intervention, you will return to complete questionnaires and memory and thinking testing. This visit will NOT include a MRI brain scan.

Will I be reimbursed or compensated?

Yes! Participants will receive monetary compensation for their time and efforts.

Frequently Asked Questions

  • How long is the study? The length of your participation in the study will vary. The screening visit will be completed within about 4 weeks from the beginning of the baseline period. All baseline procedures will be completed within 4 weeks of entering the baseline period. Following the baseline period, your participation in the study will last about 17 weeks (daily intervention for 4 weeks, post-intervention study visit, 3-month follow-up visit).
    Why do I need to come in daily for the intervention? There are multiple components to the computerized cognitive training. Ample time is needed with each component, as well as with the tDCS, in order to induce the desired changes in cognitive and brain functioning. Think of it like going to the gym -- you need to work on the "cognitive weakness" daily in order to "strengthen the muscle." This will help to maximize the potential benefit of this combination of interventions.
    Will I receive results from my study? We will notify you if there are any clinically important findings.
    If I am experiencing symptoms of depression, do I have to already be diagnosed with depression to participate? No! You do not need to already be diagnosed with depression to participate. An assessment will be done at the screening visit to determine if you are eligible for the study.
    I have a history of depression, but am not currently experience symptoms. Can I participate? Yes - as long as your last depressive episode was relatively recent (within the past 3 years). We will assess for this at the screening visit.
    What if I have other mental health problems? People with anxiety are potentially eligible. Individuals with a history of Bipolar Disorder, Post-Traumatic Stress Disorder (PTSD), Obsessive Compulsive Disorder (OCD), and Schizophrenia are not eligible at this time.
    What if I am already taking a medication for the treatment of depression? You may participate if you are taking a therapeutic dose of an allowable antidepressant medication. You will be asked to continue that medication throughout the study. If you are not taking an antidepressant medication(s),you may still be eligible to participate. If you are taking a medication that is not allowed, you may be eligible for a separate study that includes treatment with antidepressant medications.
    Are there any medical conditions that would exclude me from participating? 

    Yes. You CANNOT participate if you have a history of: 

    • Major neurological disorders, such as dementia, stroke, brain tumors, seizures, Parkinson’s Disease, or Multiple Sclerosis (MS).
    • Surgical implants that send electrical signals, such as pacemakers, cardio defibrillators, and spinal cord stimulators.
    What if I don’t live close to Vanderbilt University Medical Center? Volunteers must be able to attend study visits at VUMC. Unfortunately, travel reimbursement is not available and there is not an option to complete the study remotely.
    How can I volunteer? If you are aged 60 years or older, click here to contact us.
  • What does tDCS involve? 

    tDCS is non-invasive (as it does not involve penetrating the skin or a body cavity) and uses small currents of electricity applied to both sides of your forehead to potentially stimulate your brain’s ability to process and learn.

    Participants will be randomized to receive either active or sham (i.e., placebo) tDCS. There is an equal chance of receiving either brain stimulation treatment.

    You will sit comfortably in a chair and complete the computerized cognitive training while you receive tDCS. This will occur daily for about 1.5 hours over 4 weeks (or for 20 sessions).

    Are there any known risks of tDCS? 

    You may experience itching and tingling or mild discomfort at the area of stimulation and headache. Other possible side effects include dizziness and nausea. Whenever an electrical stimulation is applied to the body, it could possibly cause a seizure or abnormal heartbeat, but this has never occurred with the tDCS parameters used in this study. The application of electrical current to the brain does induce functional changes (i.e., neural plasticity) that can present as a potential risk.

    If you have concerns, please do not hesitate to contact us and bring them up.

    Do I have to receive tDCS to participate? All participants in the current study will have to participate in both the tDCS and cognitive training interventions. We may have other studies you could be eligible for that don’t involve brain stimulation. Please see the other studies listed on our website, or click here to go to our contact information. We are happy to discuss our other studies that are currently recruiting.
  • What does computerized cognitive training involve? 

    Participants will sit comfortably in a chair and complete cognitive training games on a tablet while tDCS is simultaneously administered. This will occur daily for about 1.5 hours over 4 weeks (or for 20 sessions).

    These computerized games have been specifically designed to address the memory and thinking difficulties that older adults with depression may experience. The games start out easy and then become more challenging as the intervention progresses. 

    There are multiple components to the computerized cognitive training and ample time is spent with each component to maximize its potential benefit.

    Are there any known risks of participating in the cognitive training? You may find cognitive training on the tablet challenging, fatiguing, and / or boring. You may also feel fatigued during the cognitive training sessions and breaks will be allowed as needed.
    Do I have to receive computerized cognitive training to participate? All participants in the current study will have to participate in both the tDCS and cognitive training interventions. We may have other studies you could be eligible for that don’t involve cognitive training. Please see the other studies listed on our website, or click here to go to our contact information. We are happy to discuss our other studies that are currently recruiting.
  • What does an MRI involve? An MRI scan is performed in a large machine that is shaped like a tunnel. The machine we use for our studies is open on both ends, but closed on the top. This scan does not use x-rays. Instead, they use a strong magnet and radio waves, like an AM/FM radio, to take pictures of your body. We do not give you any drugs or injections during our MRI scan(s). During the scan(s), you will hear “hammering,” clicking, or squealing noises. They are a little loud, but you will be given earplugs to reduce the noise.
    Are there any known risks of an MRI scan? 

    There are no known major risks with an MRI scan. MRIs do not use radiation.

    Before you can complete an MRI for the study, we will take a detailed medical and surgical history to assess you for MRI safety.

    However, it may be uncomfortable being in a tight space if you experience claustrophobia. Furthermore, the noises can be loud despite the ear plugs.

    You have the option to complete a “mock” MRI scan during the screening visit. It takes place in a non-operational scanner that is similar to the scanner that will be used for our studies.

    Do I have to be able to have an MRI scan to participate? Yes. MRIs are required for this study. You will complete 2 MRIs over the course of the study.
    Can I be sedated during the MRI scan(s)? No, sedation is not permitted during the MRI scan(s). We need participants to be awake so they can complete tasks in the scanner.
    I have metal implants. Are these safe for MRI? Many medical implants are MRI-safe. During the screening visit, we will evaluate you for any surgical implants that may exclude you from having an MRI.

  • We are following all appropriate public health guidelines during the COVID-19 Pandemic. We are going to be pre-screening people by phone. Once we have your information, it will be provided to the study doctor to review. We will then reach out to you via email or phone and discuss with you further screening activities.

    For more information about our safety guidelines, please click here.

    To visit the VUMC Coronavirus website, please click here.

  • The Laboratory of Affective and Cognitive Imaging is located within the Center for Cognitive Medicine at the

    Vanderbilt Psychiatric Hospital

    1601 23rd Ave South

    Nashville, TN 37212

     

  • If you have any additional questions or would like to find out if you may be eligible, please click here to be taken to our contact information.