The Efficacy of Transcranial Direct Current Stimulation Combined With the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders: a Double Blind, Sham Controlled, Randomized Factorial Designed Study for Anxiety Disorders
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Hamilton Anxiety Rating Scale (HARS; Hamilton, 1959)
研究概览
简要总结
The main goal of the study is to test the efficacy of tDCS in combination with the Unified Protocol for transdiagnostic treatment of emotional disorders, to reduce anxiety symptoms in a mixed anxiety disorders sample, as assessed by the Hamilton Anxiety Rating Scale (HARS; Hamilton, 1959).
详细描述
Participants will be randomly allocated to one of four parallel experimental arms, within a 2X2 factorial design in which two interventions (tDCS and CBT-UP) will be delivered, and assessed according to two levels (e.g., intervention vs. no intervention).
Each study participant will assigned to one factor level. Four intervention groups are defined
- active tDCS + CBT-UP
- sham tDCS + CBT-UP
- active tDCS + Psychoeducation
- sham tDCS + Psychoeducation
The four arms allow to experimentally control the two active therapeutic interventions: active tDCS and CBT-UP. Sham tDCS is the control for active tDCS and psychoeducation is the control condition for CBT-UP.
The intervention will last for 15 weeks, and all groups will comply with the same intervention structure according to the examination plan established in the protocol:
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
- Double (Participant, Outcomes Assessor)
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
- •Diagnosis of generalized anxiety disorder, specific phobia, panic disorder, agoraphobia, or social anxiety disorder.
- •Willing to participate and to give written informed consent
排除标准
- •Contra-indications to tDCS use:
- •Presence of a cardiac or neurological condition
- •Metallic implants
- •If contact with scalp is not possible
- •Have had a head injury resulting in a loss of consciousness that has required further investigation
- •History of seizures
- •Epilepsy or a history of epilepsy
- •Past adverse effects with non-invasive stimulation treatments
- •Current diagnosis of another psychiatric disorder (except for depression, as long as secondary diagnosis), psychoactive medication or psychological treatment
- •Left-handedness
- •Skin condition on the stimulation target area
- •Recreational drug use
结局指标
主要结局
Hamilton Anxiety Rating Scale (HARS; Hamilton, 1959)
时间窗: At week 8th, 15th (middle and end of treatment) and 6 months follow-up
The mean change in the Hamilton Anxiety Rating Scale (HARS; Hamilton, 1959) score, from baseline. HARS total score ranges from 0 to 56, where higher values indicate higher anxiety symptom's severity.
次要结局
- Remission to treatment(At week 8th, 15th (middle and end of treatment) and 6 months follow-up.)
- Hamilton Depression Rating Scale (HRSD; Hamilton, 1960)(At week 8th, 15th (middle and end of treatment) and 6 months follow-up.)
- Response to treatment(At week 8th, 15th (middle and end of treatment) and 6 months follow-up.)
研究者
Ana Ganho Ávila
Integrated Researcher
University of Coimbra