Effects and Mechanisms of Transcranial Direct Current Stimulation Combined With Dialectical Behavior Therapy Skills Training in Adults With Attention-Deficit/Hyperactivity Disorder

NCT07565402 | Recruiting

• 1 other identifier: 2026-KY022-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Attention Deficit Hyperactivity Disorder

Keywords

adult ADHD; transcranial direct current stimulation; dialectical behavior therapy; DBT skills training; executive function; resting-state fMRI

Outcome Measures

Primary Outcomes (1)

• Change in ADHD symptoms as measured by the Adult ADHD Self-Report Scale (ASRS)

  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).

  Baseline to 10 weeks (post-intervention)

Secondary Outcomes (6)

• Change in executive function performance as measured by the Stop-Signal Task (SST)

  Baseline to 10 weeks

• Change in emotion regulation ability as measured by the Difficulties in Emotion Regulation Scale (DERS)

  Baseline to 10 weeks (post-intervention)

• Change in anxiety symptoms as measured by the Generalized Anxiety Disorder-7 (GAD-7)

  Baseline to 10 weeks (post-intervention)

• Change in resting-state functional connectivity within prefrontal regulatory networks

  Baseline to 10 weeks (post-intervention)

• Maintenance of treatment effects at 1-month follow-up

  1-month follow-up

Study Arms (2)

Active tDCS + DBT-ST

EXPERIMENTAL

Participants receive active transcranial direct current stimulation (tDCS) over the bilateral dorsolateral prefrontal cortex combined with dialectical behavior therapy skills training (DBT-ST).

Device: Transcranial Direct Current Stimulation (tDCS)

Sham tDCS + DBT-ST

SHAM COMPARATOR

Participants receive sham transcranial direct current stimulation (tDCS) combined with dialectical behavior therapy skills training (DBT-ST).

Device: Transcranial Direct Current Stimulation (tDCS)

Interventions

Transcranial Direct Current Stimulation (tDCS) DEVICE

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.

Also known as: tDCS

Active tDCS + DBT-ST; Sham tDCS + DBT-ST

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

Nanjing Brain Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Chun Wang, PhD

  Nanjing Brain Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun Wang, PhD

CONTACT

15850566376; wang_chun@nju.edu.cn

Yu Xin Luo

CONTACT

18982002847; felicia18982002847@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: May 4, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 21, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

CN (1)