Augmentation Von Online-Psychotherapie Mit tDCS Bei Der Aufmerksamkeitsdefizit-/Hyperaktivitätsstörung (ADHS)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Compliance (Number of days (60) of actual (Placebo-)tDCS-treatment)
研究概览
简要总结
A randomized controlled two-arm study (RCT) will be conducted. It is planned to randomly assign eligible patients who receive a three-month access to the psychotherapeutic program (Attexis) to either an additional verum-tDCS or placebo-tDCS condition.
详细描述
The aim of this study is to determine whether the effectiveness of the home-based therapy program "Attexis" can be augmented with another home-based procedure, tDCS treatment, in order to achieve even higher improvement rates in the treatment of ADHD in the future. Before the actual start of treatment with Attexis, the presence of an ADHD diagnosis (ICD-10: F90.0) is checked by qualified medical staff at Medbo Regensburg. If the screened patient then meets the other inclusion criteria for Attexis and tDCS, he or she will be randomly assigned to either the intervention group (receives access to both Attexis and tDCS) or the placebo group (receives access to both Attexis and placebo tDCS). Based on the study by Schlechter et al. (2023), it is planned to treat patients receiving (placebo) tDCS treatment with 60 sessions (2mA, 20 minutes per day) by stimulating the left DLPFC. As patients will have a three-month access to Attexis, it is planned to administer the additional (placebo) tDCS treatment at the same time. As soon as a patient registers for the study, the safety aspects and inclusion/exclusion criteria for tDCS treatment are also checked in an initial interview after the ADHD diagnosis has been verified. The patient is then randomly assigned to one of the two study arms. A suitable appointment is then arranged for the patient to be admitted to the device. About 60 minutes are scheduled for the explanation and instruction of the tDCS device. During the appointment, an initial trial treatment is carried out so that the patient can get used to the treatment. All subsequent home-based treatments are carried out from Monday to Friday (each lasting 20 minutes) with video observation during the first week of treatment. For the sessions via teletherapy, software approved for clinical use (CLICKDOC version 5.9.1, La-Well Systems GmbH, CompuGroup Medical SE & Co. KGaA, Bünde, Germany) is to be used. At the end of the tDCS treatment, a final consultation will be arranged, which will take about 45 minutes. A follow-up (clinical ratings and attention test) will be carried out after 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gender: female, male, non-binary
- •Age: 18 - 65
- •Diagnosis of ADHD according to ICD-10
- •ADHD severity score (cut-off): Score of ≥17 on either the inattention subscale or the impulsivity/hyperactivity subscale of the ASRS v1.1
- •Stable treatment (psychotherapy, medication, no treatment, ...) (if applicable) for at least 30 days at the time of admission
- •Consent to participate
- •Sufficient knowledge of the German language
排除标准
- •Fulfillment of the contraindications for tDCS (electrical implants or metallic objects in the body such as pacemakers or insulin pumps, skin diseases on the head)
- •Neurological diseases (e.g. cerebrovascular events, neurodegenerative diseases, epilepsy, brain malformation, history of severe head injuries)
- •Participation in another study during treatment
- •Pregnancy or breastfeeding
- •Diagnosis of a comorbid clinically relevant severe psychiatric disorder (severe affective disorder, autism spectrum disorder, psychotic disorder, borderline personality disorder, antisocial personality disorder, substance use disorder, suicidality)
- •Plan to change an ongoing treatment (psychotherapy, medication, ...) in the next three months after enrollment in the study
结局指标
主要结局
Compliance (Number of days (60) of actual (Placebo-)tDCS-treatment)
时间窗: 12 weeks
Number of days of treatment with (Placebo-)tDCS
Efficacy 1 (Number of responders according to the ASRS-v1.1)
时间窗: 12 weeks
(Number of responders according to the ASRS-v1.1)
Efficacy 2 (Number of responders according to the subscale attention of the ASRS-v1.1)
时间窗: 12 weeks
Number of responders according to the subscale attention of the ASRS-v1.1
Efficacy 3 (Number of responders according to the subscale hyperactivity of the ASRS-v1.1)
时间窗: 12 weeks
Number of responders according to the subscale hyperactivity of the ASRS-v1.1
Stability of effects (Number of responders according to the change of the final ASRS-v1.1 sumscore)
时间窗: 24 weeks
Number of responders according to the change of the ASRS-v1.1 sumscore after treatment
次要结局
- Adult ADHD Self-Report Scale Symptom Checklist (ASRS-v1.1, Subscale: hyperactivity)(12 weeks)
- Adult ADHD Self-Report Scale Symptom Checklist (ASRS-v1.1, sumscore)(12 weeks)
- Adult ADHD Self-Report Scale Symptom Checklist (ASRS-v1.1, Subscale: Attention)(12 weeks)
- Usability (sumscore of the Usability experience questionnaire UEQ)(12 weeks)
研究者
Berthold Langguth, MD, Ph.D.
Clinical Professor, MD, PhD
University of Regensburg