Cognitive Training + tDCS for Depression

Overseen By Sarah M Szymkowicz, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Must not be taking: Sodium channel blockers, anticonvulsants

Disqualifiers: Other Axis I, Neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will investigate whether transcranial direct current stimulation (tDCS) enhances the effects of computerized cognitive training in older adults with recurrent depression (2 or more lifetime episodes; either current or within past 3 years).

Will I have to stop taking my current medications?

The trial requires that participants either have a stable antidepressant regimen for at least 6 weeks or not be on any current antidepressant treatment. However, you cannot participate if you are taking medications that significantly interact with tDCS, like sodium channel blockers or anticonvulsants.

What data supports the effectiveness of this treatment for depression?

Research shows that computerized cognitive training (CCT) can improve mood and cognitive function in people with depression. Additionally, combining CCT with other interventions has been effective in improving functional outcomes in mental health settings. ^{1 2 3 4 5}

Is Cognitive Training + tDCS safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe with very low side effects, even when used at home with supervision. Computerized cognitive training (CCT) is also regarded as safe for enhancing cognitive performance in various clinical populations. ^{5 6 7 8 9}

How is the Cognitive Training + tDCS treatment for depression different from other treatments?

Cognitive Training combined with transcranial direct current stimulation (tDCS) is unique because it uses computer-based exercises to improve thinking and emotional skills, alongside a noninvasive brain stimulation technique to enhance mood and cognitive function. This approach is different from traditional drug treatments as it focuses on strengthening cognitive abilities and emotional regulation without medication. ^{5 9 10 11 12}

Research Team

Sarah M Szymkowicz, PhD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

This trial is for adults aged 60 and over who have been diagnosed with Major Depressive Disorder, as per DSM-5 criteria. They should be experiencing cognitive complaints and a depression severity of 15+ on the MADRS scale. Participants must speak English fluently and either be on a stable antidepressant regimen for at least six weeks or not taking any antidepressants.

Inclusion Criteria

You have reported problems with memory and thinking on a specific questionnaire.

My depression is severe, scoring 15 or more on a scale.

I have been on the same antidepressant for at least 6 weeks or am not taking any.

Exclusion Criteria

You have a significant memory problem compared to other people your age, even though your overall thinking skills seem normal.

I have a neurological disorder such as dementia, stroke, or Parkinson's.

Current involvement in other research studies (including but not limited to: neuromodulation [TMS or tDCS] or investigational drug studies)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active or sham tDCS combined with daily computerized cognitive remediation over 4 weeks

4 weeks

Daily visits for treatment

Follow-up

Participants are monitored for cognitive and psychiatric outcomes post-intervention

3 months

Cognitive assessments at 3 months post-intervention

Treatment Details

Interventions

• Cognitive Training
• tDCS (active stimulation)
• tDCS (sham stimulation)

Trial Overview The study examines if transcranial direct current stimulation (tDCS), which uses mild electrical currents applied to the head, can improve cognitive function when combined with cognitive training in older adults suffering from depression.

Participant Groups

Group I: Cognitive Training + Sham Stimulation Experimental Treatment 2 Interventions

This arm receives cognitive training combined with sham tDCS.

Group II: Cognitive Training + Active Stimulation Experimental Treatment 2 Interventions

This arm receives cognitive training combined with active tDCS.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

American Academy of Neurology

Collaborator

Trials

12

Recruited

370+

Findings from Research

Computerized cognitive training (CCT) using Brain HQ showed significant cognitive improvements in psychiatric rehabilitation clients, with an average increase of 4.4 points in BACS t-scores after about 17 days of training.

Higher engagement in training (measured by levels completed per day) was positively correlated with cognitive gains, suggesting that monitoring engagement can help identify patients who may need additional support to benefit from CCT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training engagement, baseline cognitive functioning, and cognitive gains with computerized cognitive training: A cross-diagnostic study. Harvey, PD., Balzer, AM., Kotwicki, RJ.[2020]

In a study involving 46 young adults with mild depressive symptoms, executive functioning and processing speed (EF/PS)-focused computerized cognitive training (CCT) led to greater improvements in those specific cognitive areas compared to verbal ability-focused CCT.

Both types of CCT resulted in significant improvements in mood and everyday functioning, but the EF/PS group achieved similar mood benefits with only half the training time, suggesting that the content of CCT may not be as crucial as the engagement in the training itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized cognitive training in young adults with depressive symptoms: Effects on mood, cognition, and everyday functioning. Motter, JN., Grinberg, A., Lieberman, DH., et al.[2019]

A 2-year follow-up study involving 42 participants with major depressive disorder showed that Goal Management Training (GMT) led to long-term reductions in depressive symptoms and rumination, while drill-and-practice cognitive training (CCT) did not show significant differences in outcomes.

Despite improvements in mental health from GMT, everyday executive functions did not show sustained improvement, suggesting that additional treatment may be necessary to maintain these cognitive benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Goal Management Training and Computerized Cognitive Training in Depression-a 2-Year Follow-Up of a Randomized Controlled Trial. Hagen, BI., Stubberud, J.[2021]

In a study involving 75 severely depressed psychiatric inpatients, metacognitive training for depression (D-MCT) did not show a significant added benefit over standard cognitive-behavioral therapy (CBT) in reducing overall depression severity, but it was particularly effective for patients with major depressive disorder (MDD) without comorbidities, leading to greater improvements in depressive cognition.

Patients reported higher satisfaction, motivation, and treatment preference for D-MCT, indicating it is a well-accepted and feasible intervention in acute psychiatric care, although further research is needed to assess its long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of metacognitive training for depression as add-on intervention for patients with depression in acute intensive psychiatric inpatient care: A randomized controlled trial. Hauschildt, M., Arlt, S., Moritz, S., et al.[2022]

This study aims to systematically review and analyze the efficacy of computerized cognitive training (CCT) in improving cognitive performance in adults with depression, focusing on randomized controlled trials.

The research will explore how CCT affects not only cognitive outcomes but also mood and daily functioning, making it the first comprehensive analysis of its kind in this specific clinical population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized cognitive training in people with depression: a protocol for a systematic review and meta-analysis. Lampit, A., Launder, NH., Minkov, R., et al.[2022]

Transcranial direct current stimulation (tDCS) is generally considered a safe treatment for major depressive disorder, with very low side effects reported, making it a viable option for patients.

While meta-analyses indicate some efficacy of tDCS for acute depression with a moderate effect size, its effectiveness is reduced in treatment-resistant cases, suggesting that more research is needed to establish its overall therapeutic value.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

tDCS for the treatment of depression: a comprehensive review. Palm, U., Hasan, A., Strube, W., et al.[2018]

A home-based protocol for transcranial direct current stimulation (tDCS) was tested on 26 participants with major depressive disorder (MDD) over 6 weeks, showing significant improvement in depressive symptoms that persisted for at least 6 months.

The treatment was highly acceptable to participants, with 92.3% completing the study, indicating that tDCS could be a feasible and effective option for managing MDD outside of clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive home-based transcranial direct current stimulation treatment for major depression with real-time remote supervision: An open-label, single-arm feasibility study with long term outcomes. Woodham, RD., Rimmer, RM., Young, AH., et al.[2022]

Transcranial direct current stimulation (tDCS) shows potential for reducing symptoms of major depression, particularly when applied to frontal brain regions, but results have been inconsistent across studies.

Currently, no tDCS devices are FDA-cleared for clinical use, and while older systems have some regulatory approval, they lack demonstrated efficacy in rigorous trials, highlighting the need for more research and education in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation in Psychiatry: What Psychiatrists Need to Know. Zandvakili, A., Berlow, YA., Carpenter, LL., et al.[2020]

In a case series of 16 treatment-resistant depression patients, home-administered transcranial direct current stimulation (HA-tDCS) showed clinical benefits, with 5 out of 12 patients responding within 6 weeks and 9 maintaining improvements after 12 weeks of treatment.

HA-tDCS was found to be safe and well-tolerated, with no significant cognitive impairments reported over up to 2 years of treatment, although two patients experienced mild side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Clinical Case Series of Acute and Maintenance Home Administered Transcranial Direct Current Stimulation in Treatment-Resistant Depression. Le, B., Alonzo, A., Bull, M., et al.[2023]

In a pilot study involving 31 patients with drug-resistant depression, combining transcranial direct current stimulation (tDCS) with mindfulness-based cognitive therapy (MBCT) showed better long-term maintenance of clinical improvements compared to tDCS with relaxation.

Both treatment conditions improved symptoms of depression, but the tDCS and MBCT combination was more effective in sustaining reductions in depression and cognitive symptoms two weeks after treatment, suggesting a promising multi-disciplinary approach for resistant depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Resistant Depression: A Pilot Study Assessing the Efficacy of a tDCS-Mindfulness Program Compared With a tDCS-Relaxation Program. Monnart, A., Vanderhasselt, MA., Schroder, E., et al.[2023]

A randomized controlled trial with 112 participants showed that cognitive and emotional remediation training (CERT-D) significantly improved psychosocial function and reduced symptom severity in individuals with Major Depressive Disorder (MDD).

The training focused on enhancing cognitive, emotional, and social-cognitive skills through repeated exercises, suggesting that this approach could be a cost-effective alternative to traditional psychological therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological training to improve psychosocial function in patients with major depressive disorder: A randomised clinical trial. Knight, MJ., Lyrtzis, E., Fourrier, C., et al.[2023]

Cognitive Control Training (CCT) significantly reduced negative mood in participants with high depression scores, showing a large effect size (d = 0.73) compared to a control group that received Peripheral Vision Training (PVT).

The study involved 48 participants over a 2-week period, and results indicated that better performance in CCT was associated with improved mood, suggesting that enhancing cognitive focus can positively impact emotional well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Computerized Cognitive Control Training on Community Adults with Depressed Mood. Calkins, AW., McMorran, KE., Siegle, GJ., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Training engagement, baseline cognitive functioning, and cognitive gains with computerized cognitive training: A cross-diagnostic study. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Computerized cognitive training in young adults with depressive symptoms: Effects on mood, cognition, and everyday functioning. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Goal Management Training and Computerized Cognitive Training in Depression-a 2-Year Follow-Up of a Randomized Controlled Trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Efficacy of metacognitive training for depression as add-on intervention for patients with depression in acute intensive psychiatric inpatient care: A randomized controlled trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Computerized cognitive training in people with depression: a protocol for a systematic review and meta-analysis. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

tDCS for the treatment of depression: a comprehensive review. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Adjunctive home-based transcranial direct current stimulation treatment for major depression with real-time remote supervision: An open-label, single-arm feasibility study with long term outcomes. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation in Psychiatry: What Psychiatrists Need to Know. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

A Clinical Case Series of Acute and Maintenance Home Administered Transcranial Direct Current Stimulation in Treatment-Resistant Depression. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Treatment of Resistant Depression: A Pilot Study Assessing the Efficacy of a tDCS-Mindfulness Program Compared With a tDCS-Relaxation Program. [2023]

11. Ireland pubmed.ncbi.nlm.nih.gov

Psychological training to improve psychosocial function in patients with major depressive disorder: A randomised clinical trial. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

The Effects of Computerized Cognitive Control Training on Community Adults with Depressed Mood. [2022]