Effects and Mechanisms of Transcranial Direct Current Stimulation Combined With Dialectical Behavior Therapy Skills Training in Adults With Attention-Deficit/Hyperactivity Disorder
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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Chun Wang, PhD
- 電話番号：15850566376
- メール：wang_chun@nju.edu.cn
研究連絡先のバックアップ
- 名前：Yu Xin Luo
- 電話番号：18982002847
- メール：felicia18982002847@163.com
研究場所
-
-
Jiangsu
-
Nanjing、Jiangsu、中国、210029
- 募集
- Nanjing Brain Hospital
-
コンタクト：
- Chun Wang, PhD
- 電話番号：15850566376
- メール：wang_chun@nju.edu.cn
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Active tDCS + DBT-ST
Participants receive active transcranial direct current stimulation (tDCS) over the bilateral dorsolateral prefrontal cortex combined with dialectical behavior therapy skills training (DBT-ST).
|
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.
他の名前：
|
|
偽コンパレータ：Sham tDCS + DBT-ST
Participants receive sham transcranial direct current stimulation (tDCS) combined with dialectical behavior therapy skills training (DBT-ST).
|
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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in ADHD symptoms as measured by the Adult ADHD Self-Report Scale (ASRS)
時間枠：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).
|
Baseline to 10 weeks (post-intervention)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in executive function performance as measured by the Stop-Signal Task (SST)
時間枠：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.
|
Baseline to 10 weeks
|
|
Change in emotion regulation ability as measured by the Difficulties in Emotion Regulation Scale (DERS)
時間枠：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.
|
Baseline to 10 weeks (post-intervention)
|
|
Change in anxiety symptoms as measured by the Generalized Anxiety Disorder-7 (GAD-7)
時間枠：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.
|
Baseline to 10 weeks (post-intervention)
|
|
Change in resting-state functional connectivity within prefrontal regulatory networks
時間枠：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.
|
Baseline to 10 weeks (post-intervention)
|
|
Maintenance of treatment effects at 1-month follow-up
時間枠：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.
|
1-month follow-up
|
|
Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
時間枠：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.
|
Baseline to 10 weeks (post-intervention)
|
協力者と研究者
捜査官
- 主任研究者：Chun Wang, PhD、Nanjing Brain Hospital
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2026-KY022-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。