Efficacy of Hypnotherapy Compared to a Wait-list Control Group in the Treatment of Agoraphobia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Panic and Agoraphobia Scale (PAS)
研究概览
简要总结
The purpose of the study is to compare the efficacy of Hypnotherapy for the treatment of Agoraphobia compared to a wait-list control group.
详细描述
With the present study, the efficacy of 8-12 sessions of individual Hypnotherapy will be compared to a wait-list control groups. At study entry and at the end of treatment with Hypnotherapy, the Agoraphobia symptoms will be assessed via clinician-rating and self-report. It is expected that Hypnotherapy will be superior to a wait-list control regarding the percentage reduction of the anxiety symptoms after three months of treatment.
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 (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
- •Written informed consent
- •Patient fulfills DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria for agoraphobia
- •18 - 65 years of age
- •Sufficient knowledge of the German language in order to participate in the study
- •Sufficient availability to participate in weekly therapy sessions
排除标准
- •Acute suicidality (intended action, concrete plans or intermittent pronounced suicidal ideation)
- •Lifetime diagnosis of a bipolar disorder or psychotic disorder
- •Alcohol or substance use disorder without abstinence in the last 12 months
- •Severe cognitive impairments (in cases of suspicion evaluation via Mini Mental State Test (MMST) < 26, will be conducted)
- •Other severe primary mental disorders to be treated: severe Major Depressive Disorder, severe personality disorder of borderline type with self-injury, severe combined personality disorder, actual posttraumatic stress disorder, anorexia nervosa, obsessive compulsive disorder
- •Somatic disorder impeding participation in regular psychotherapy sessions
- •Outpatient psychotherapy during the last twelve months.
- •Medication with anxiolytics or anti-psychotics (antidepressant medication is permitted if stable since more than eight weeks and no planned changes during the duration of therapy)
结局指标
主要结局
Panic and Agoraphobia Scale (PAS)
时间窗: Between baseline (t1) and after 12 weeks (t2)
The clinician-rating PAS will be used to measure the symptom severity (range 0-56 with higher values indicating more symptoms) for the primary outcome that is defined as the (mean) percentage change of the total symptom score between baseline (t1) and after 12 weeks (t2).
次要结局
未报告次要终点
研究者
Anil Batra
Prof. Dr. Anil Batra, Pricinpal Investigator
University Hospital Tuebingen