Cognitive Training + tDCS for Depression
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Vanderbilt University Medical Center
No Placebo Group
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).
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.
2691112What 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.
358910How 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.
147911Will 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.
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
My depression is severe, scoring 15 or more on a scale.
I am 60 years old or older.
I have been diagnosed with Major Depressive Disorder.
Exclusion Criteria
I have a neurological disorder such as dementia, stroke, or Parkinson's.
I am not on medication that affects brain stimulation treatments.
I do not have disabilities that affect my ability to complete health assessments.
My memory and thinking test score is below 23.
I haven't had ECT or TMS in the last 2 months.
I do not have any urgent medical conditions needing immediate treatment.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Cognitive Training + Sham StimulationExperimental Treatment2 Interventions
This arm receives cognitive training combined with sham tDCS.
Group II: Cognitive Training + Active StimulationExperimental Treatment2 Interventions
This arm receives cognitive training combined with active tDCS.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Vanderbilt University Medical CenterNashville, TN
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
American Academy of NeurologyCollaborator
References
The Effects of Computerized Cognitive Control Training on Community Adults with Depressed Mood. [2022]Depression is frequently characterized by patterns of inflexible, maladaptive, and ruminative thinking styles, which are thought to result from a combination of decreased attentional control, decreased executive functioning, and increased negative affect. Cognitive Control Training (CCT) uses computer-based behavioral exercises with the aim of strengthening cognitive and emotional functions. A previous study found that severely depressed participants who received CCT exhibited reduced negative affect and rumination as well as improved concentration.
tDCS for the treatment of depression: a comprehensive review. [2018]Transcranial direct current stimulation (tDCS) has been investigated for the treatment of major depressive disorders in recent years. Here, we review the implications of current research for the clinical use of tDCS in the treatment of major depressive disorder. Meta-analyses, randomized, placebo-controlled clinical trials, open-label trials, case reports and review articles were identified through a systematic search of the literature database of the National Institutes of Health (USA). Available articles were evaluated with regard to their clinical relevance. Results of tDCS efficacy are inconsistent due to the small sample sizes, the heterogeneous patient samples and the partially high treatment resistance in some studies. Overall, tDCS has very low side effects. Meta-analyses suggest some efficacy of tDCS in the treatment of acute depressive disorder with moderate effect size, and low efficacy in treatment-resistant depression. A general statement about the efficacy of tDCS as a therapeutic tool in major depression seems to be premature. tDCS is considered as a safe therapeutic option and is associated with only minor side effects. The effectiveness of tDCS decreases with resistance to treatment. Psychotropic drugs may attenuate or amplify its effects. The use of 2 mA current strength over 20 min per day over a short time span can be considered as safe.
Computerized cognitive training in young adults with depressive symptoms: Effects on mood, cognition, and everyday functioning. [2019]Computerized cognitive training (CCT) has previously improved cognition and mood in people with depression. Existing research has not determined if the benefits following CCT are specific to the content of CCT or are a function of participation in an engaging activity. In this double-blind randomized controlled trial, we tested whether executive functioning and processing speed (EF/PS)-focused CCT could outperform verbal ability-focused CCT.
Treatment of Resistant Depression: A Pilot Study Assessing the Efficacy of a tDCS-Mindfulness Program Compared With a tDCS-Relaxation Program. [2023]Background: This pilot study explores a therapeutic setting combining transcranial direct current stimulation (tDCS) and mindfulness-based cognitive therapy (MBCT) for patients with drug-resistant depression. tDCS has shown efficacy for depression treatment and improvement could be maintained with the combination with mindfulness, which has shown depression relapse-prevention properties. Methods: Thirty-one treatment-resistant depressed patients have been assigned to our experimental treatment condition [tDCS combined with MBCT (n = 15)] or to a control condition [tDCS combined with relaxation (n = 16)]. Patients have completed both an intensive treatment block (eight consecutive days) and a single remind session 2 weeks after the intensive treatment. Clinical (depression, anxiety, and rumination) and cognitive (general cognitive functioning, mental flexibility, and working memory) symptoms of depression have been assessed through different questionnaires at baseline (t0), after the first block of treatment (t1), and after the remind session (t2). Results: Results seem to indicate a positive impact of both treatment conditions on clinical and cognitive symptoms of depression at t1. However, the treatment condition combining tDCS with mindfulness has been found to better maintain clinical improvements at t2 regarding some clinical [Montgomery-Åsberg Depression Rating Scale (MADRS) and Sadness and Anger Ruminative Inventory (SARI)] and cognitive variables (Digit Span-F and Digit Span-B). Conclusion: Based on the current observations, a multi-disciplinary treatment approach combining tDCS and MBCT might be effective in resistant depressed patients in the long run, even though further clinical research is necessary.
Training engagement, baseline cognitive functioning, and cognitive gains with computerized cognitive training: A cross-diagnostic study. [2020]Computerized cognitive training (CCT) interventions are increasing in their use in outpatient mental health settings. These interventions have demonstrated efficacy for improving functional outcomes when combined with rehabilitation interventions. It has recently been suggested that patients with more cognitive impairment have a greater therapeutic response and that reduced engagement in training can identify cases who manifest low levels of benefit from treatment. Participants were psychiatric rehabilitation clients, with diagnoses of major depression, bipolar disorder and schizophrenia. Newly admitted cases received CCT, delivered via Brain HQ, with cognitive functioning divided into groups on the basis of a BACS t-score of 40 or less vs. more. Training engagement was indexed by the number of training levels achieved per day trained. Forty-nine cases trained on average for 17 days and completed a mean of 150 levels. Overall, patients improved by an average of 4.4 points (0.44 SD) in BACS t-scores (p < .001). Improvements were positively correlated with training engagement (r = 0.30, p < .05), but not with days trained (r = 0.09) or levels earned (r = 0.03) alone. Patients with higher levels of baseline cognitive performance had reduced cognitive gains (p < .003), but did not have less training engagement (p = .97). Diagnoses did not predict cognitive gains (p = .93) or target engagement (p = .74). Poorer performance at baseline and higher levels of training engagement accounted for >10% in independent variance in cognitive gains. The mean level of cognitive improvement far exceeded practice effects. The index of engagement, levels achieved per training day, is easily extracted from the training records of patients, which would allow for early and continuous monitoring of treatment engagement in CCT activities and therapist intervention as needed to improve engagement.
Transcranial Direct Current Stimulation in Psychiatry: What Psychiatrists Need to Know. [2020]Transcranial direct current stimulation (tDCS) is emerging as a potential treatment for a host of neuropsychiatric disorders. Data appear to indicate that tDCS applied over frontal or prefrontal brain regions may reduce symptoms of major depression, yet results have been mixed. Early studies showed promise, but recent work failed to replicate earlier results. The decision whether to use tDCS is further affected by the complex regulatory environment; no tDCS devices are cleared by the U.S. Food and Drug Administration for clinical use. Older systems have grandfathered regulatory approval for treating mood, anxiety, and insomnia, although they have not demonstrated efficacy in rigorous trials. Furthermore, as the field of noninvasive brain stimulation advances, various side effects and contraindications are increasingly recognized. Over the last few years, research and consumer use of tDCS have outpaced education, thus providing little guidance for clinicians and trainees about how to understand tDCS. Therefore, this focused review includes those items psychiatric clinicians and trainees most need to understand tDCS, including basic electrical and neurophysiological principles, a brief review of efficacy data in major depressive disorder, and suggested guidelines about how to manage patients using tDCS.
Psychological training to improve psychosocial function in patients with major depressive disorder: A randomised clinical trial. [2023]Cognitive and emotional remediation training for depression (CERT-D): a randomised controlled trial to improve cognitive, emotional and functional outcomes in depression The aim of the current study was to evaluate an experimental treatment designed to improve psychosocial function in patients with Major Depressive Disorder (MDD) by reinforcing cognitive, emotional, and social-cognitive abilities. Participants (N = 112) with current or lifetime MDD were recruited to participate in a randomised, blinded, controlled trial. Exclusion criteria included diagnosis of a substance abuse disorder, bipolar disorder organic, eating disorders, or illness which affect cognitive function. The treatment involved repeated cognitive training designed to improve cognitive, emotional, and social-cognitive abilities. In training sessions, the principles of cognitive training were applied across cognitive, emotional, and social domains, with participants completing repeated mental exercises. Exercises included critically analysing interpretations of social interactions (e.g., body language), exploring emotional reactions to stimuli, and completing game-like cognitive training tasks. Training sessions placed great emphasis on the application of trained cognitive, emotional, and social cognitive skills to psychosocial outcomes. Outcomes demonstrated significant improvement in psychosocial function, symptom severity, self-reported cognition, and social-cognition. Our findings demonstrate the efficacy of multi-domain cognitive training to improve psychosocial functioning in individuals with MDD. We suggest that the present treatment could be deployed at a lower cost and with minimal training in comparison to established psychological therapies.
Goal Management Training and Computerized Cognitive Training in Depression-a 2-Year Follow-Up of a Randomized Controlled Trial. [2021]Objective: Information on the long-term effects of cognitive remediation (CR) in major depressive disorder (MDD) is lacking. The present study reports 2-year follow-up data from a previously published randomized controlled trial (RCT) from our research group, comparing Goal Management Training (GMT), a strategy-based CR intervention, to drill-and-practice computerized cognitive training (CCT). In previous work, we found comparable improvements in executive function (EF), in addition to reductions in depressive symptoms, following both GMT and CCT at 6-month follow-up. Methods: Forty-two participants of the RCT, all diagnosed with MDD, were invited to complete rating-scales pertaining daily-life EF, rumination, and depressive symptoms. Explorative analyses compared the 2-year follow-up with previously published baseline and 6-month follow-up data, using non-parametric statistics. Similarly, GMT and CCT were compared at the 2-year follow-up, and completers were compared with non-completers. Results: Twenty participants completed the study. Overall, completers (n = 20) and non-completers (n = 22) were similar. There were no significant differences between GMT (n = 11) and CCT (n = 9) for any outcome 2 years post-treatment. Reduction compared to baseline in depressive symptoms and rumination, but not in daily-life EFs, emerged for GMT only. Conclusions: Findings suggest long-term improvements in mental health following GMT, while improvements in everyday EFs might require additional treatment or maintenance to sustain. Caution is warranted in the interpretation due to the small sample size and high attrition rates.
Computerized cognitive training in people with depression: a protocol for a systematic review and meta-analysis. [2022]People with depression often present with concurrent cognitive impairment. Computerized cognitive training (CCT) is a safe and efficacious strategy to maintain or enhance cognitive performance in a range of clinical populations. However, its efficacy in people with depression and how it varies across populations and design factors are currently unclear.
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]Metacognitive training for depression (D-MCT) is a novel low-intensity group training for economic treatment of depression. Previous studies demonstrate its efficacy in moderately depressed outpatients. The present study evaluated efficacy and patients' perspective of the D-MCT in severely depressed psychiatric inpatients.
A Clinical Case Series of Acute and Maintenance Home Administered Transcranial Direct Current Stimulation in Treatment-Resistant Depression. [2023]Transcranial direct current stimulation (tDCS) is a noninvasive neurostimulation technique being translated clinically for the treatment of depression. There is limited research documenting the longer-term effectiveness and safety of tDCS treatment. This case series is the first report of remotely supervised, home-administered tDCS (HA-tDCS) for depression in a clinical setting.
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]Current treatments for major depressive disorder (MDD) have limited effectiveness and acceptability. Transcranial direct current stimulation (tDCS) is a novel non-invasive brain stimulation method that has demonstrated treatment efficacy in MDD. tDCS requires daily sessions, however clinical trials have been conducted in research centers requiring repeated visits. As tDCS is portable and safe, it could be provided at home. We developed a home-based protocol with real-time supervision, and we examined the clinical outcomes, acceptability and feasibility. Participants were 26 MDD (19 women), mean age 40.9 ± 14.2 years, in current depressive episode of moderate to severe severity (mean 17-item Hamilton Rating Scale for Depression (HAMD) score 19.12 ± 2.12). tDCS was provided in a bilateral frontal montage, F3 anode, F4 cathode, 2 mA, each session 30 min, in a 6-week trial, for a total 21 sessions. Participants maintained their current treatment (antidepressant medication, psychotherapy, or were enrolled in online CBT). Two tDCS device brands were used, and a research team member was present in person or by real-time video call at each session. 92.3% MDD participants (n = 24) completed the 6-week treatment. Attrition rate was 7.7%. There was a significant improvement in depressive symptoms following treatment (mean HAMD 5.33 ± 2.33), which was maintained at 6 months (mean HAMD 5.43 ± 2.73). Acceptability was endorsed as "very acceptable" or "quite acceptable" by all participants. Due to the open-label feasibility design, efficacy findings are preliminary. In summary, home-based tDCS with real-time supervision was associated with significant clinical improvements and high acceptability which were maintained in the long term.