Adult Attention Deficit Hyperactivity Disorder
Conditions
Keywords
adult ADHD, transcranial direct current stimulation, dialectical behavior therapy, DBT skills training, executive function, resting-state fMRI
Brief summary
Effects and Mechanisms of Transcranial Direct Current Stimulation Combined with Dialectical Behavior Therapy Skills Training in Adults with Attention-Deficit/Hyperactivity Disorder Abstract Adult attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder that frequently persists into adulthood and is associated with substantial impairments in academic, occupational, and social functioning. Although pharmacological treatment remains the primary intervention, some adults with ADHD show limited response to medication or experience adverse effects, highlighting the need for effective non-pharmacological or combined treatment approaches. Dialectical Behavior Therapy Skills Training (DBT-ST), which emphasizes emotion regulation, impulse control, mindfulness, and behavioral organization, has shown potential in the treatment of adult ADHD. However, its therapeutic efficacy may vary across individuals, and strategies to enhance treatment outcomes still require further investigation. In parallel, transcranial direct current stimulation (tDCS), a safe and non-invasive neuromodulation technique, has attracted increasing attention as an adjunctive intervention in psychiatric disorders. Existing studies suggest that combining tDCS with psychotherapy may optimize treatment effects by modulating neural networks related to cognitive control and emotional regulation. Nevertheless, evidence for such combined interventions in adult ADHD remains limited, particularly with respect to rigorous randomized controlled designs and mechanism-based neuroimaging validation. The present study aims to investigate the efficacy and potential mechanisms of tDCS combined with DBT-ST in adults with ADHD. A randomized, double-blind, sham-controlled design will be adopted. Sixty eligible adult participants with ADHD will be randomly assigned to either an active tDCS group or a sham stimulation group, with both groups receiving weekly DBT-ST for ten consecutive weeks. tDCS will be administered over the bilateral dorsolateral prefrontal cortex (DLPFC) with 2 mA current for 20 minutes, prior to each group therapy session. Clinical symptoms, functional outcomes, and cognitive performance will be assessed at baseline, post-intervention, and one-month follow-up using standardized self-report measures and behavioral tasks. In addition, resting-state functional magnetic resonance imaging (rs-fMRI) will be conducted before and after the intervention to examine changes in functional connectivity within prefrontal regulatory networks. This study is expected to clarify whether tDCS can enhance the therapeutic effects of DBT-ST on core ADHD symptoms and related functional outcomes, and whether such effects are associated with improvements in executive function, emotion regulation, and alterations in DLPFC-related resting-state functional connectivity. By integrating clinical, behavioral, and neuroimaging measures, the study seeks to provide preliminary evidence for a novel non-pharmacological combined intervention for adult ADHD and to further elucidate its underlying neural mechanisms.
Interventions
DEVICETranscranial Direct Current Stimulation (tDCS)
Transcranial direct current stimulation (tDCS) is administered over the bilateral dorsolateral prefrontal cortex (DLPFC). In the active condition, a constant current of 2 mA is applied for 20 minutes per session, twice prior to each weekly therapy session, for 10 weeks. The anodal electrode is placed over the left DLPFC (F3) and the cathodal electrode over the right DLPFC (F4). In the sham condition, the current is ramped up and down briefly to mimic the sensation of stimulation without delivering an effective dose.
Sponsors
Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Meet the diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Diagnosis confirmed using the Chinese version of the Diagnostic Interview for ADHD in Adults (DIVA-5). * Aged between 18 and 55 years. * Right-handed. * Voluntary participation with provision of written informed consent.
Exclusion criteria
* Presence of neurological disorders or other psychiatric disorders. * Severe physical illness. * Receipt of electroconvulsive therapy (ECT) or other physical treatments within 6 months prior to enrollment. * Planned changes in ADHD-related medication before the final follow-up assessment. * Contraindications to tDCS (e.g., intracranial metal or electronic implants, skull plates, or other cranial implants). * Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ADHD symptoms as measured by the Adult ADHD Self-Report Scale (ASRS) | Baseline to 10 weeks (post-intervention) | ADHD symptom severity will be assessed using the Adult ADHD Self-Report Scale (ASRS). The ASRS is a self-administered questionnaire consisting of 18 items. The total score ranges from 0 to 72, with higher scores indicating more severe ADHD symptoms. The primary outcome is the change in ASRS total score from baseline to post-intervention (10 weeks). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in executive function performance as measured by the Stop-Signal Task (SST) | Baseline to 10 weeks | Executive function will be assessed using the Stop-Signal Task (SST). The outcome measure is the stop-signal reaction time (SSRT), reported in milliseconds. The change in SSRT from baseline to post-intervention will be analyzed. |
| Change in emotion regulation ability as measured by the Difficulties in Emotion Regulation Scale (DERS) | Baseline to 10 weeks (post-intervention) | Emotion regulation will be assessed using the Difficulties in Emotion Regulation Scale (DERS). The DERS is a 36-item self-report questionnaire. The total score ranges from 36 to 180, with higher scores indicating greater difficulties in emotion regulation. The change in DERS total score from baseline to post-intervention will be evaluated. |
| Change in anxiety symptoms as measured by the Generalized Anxiety Disorder-7 (GAD-7) | Baseline to 10 weeks (post-intervention) | Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale. The GAD-7 is a 7-item self-report questionnaire. The total score ranges from 0 to 21, with higher scores indicating more severe anxiety. The change in GAD-7 total score from baseline to post-intervention will be evaluated. |
| Change in resting-state functional connectivity within prefrontal regulatory networks | Baseline to 10 weeks (post-intervention) | Resting-state functional connectivity will be assessed using resting-state functional magnetic resonance imaging (rs-fMRI). The outcome measure is the strength of functional connectivity within prefrontal regulatory networks, focusing on the dorsolateral prefrontal cortex (DLPFC), and is expressed as Fisher's Z-transformed correlation coefficient. The change in connectivity from baseline to post-intervention will be analyzed. |
| Maintenance of treatment effects at 1-month follow-up | 1-month follow-up | Maintenance of treatment effects will be evaluated by reassessing the following clinical and cognitive outcomes at 1-month follow-up and comparing them with baseline values: ASRS total score (range 0-72, higher = worse), SST stop-signal reaction time (milliseconds), N-back d-prime (unitless), DERS total score (36-180, higher = worse), GAD-7 total score (0-21, higher = worse), PHQ-9 total score (0-27, higher = worse), and rs-fMRI DLPFC functional connectivity (Fisher's Z). Each of these measurements will be analyzed as a separate maintenance endpoint, using the same units of measure as defined in the respective outcomes above. |
| Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9) | Baseline to 10 weeks (post-intervention) | Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report questionnaire. The total score ranges from 0 to 27, with higher scores indicating more severe depression. The change in PHQ-9 total score from baseline to post-intervention will be evaluated. |
Countries
China
Contacts
CONTACTChun Wang, PhD
CONTACTYu Xin Luo
PRINCIPAL_INVESTIGATORChun Wang, PhD
Nanjing Brain Hospital
Outcome results
None listed