Providing Tools for Effective Care and Treatment of Anxiety Disorders (AD): Outcomes, Mediators and Moderators of Enhanced Extinction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 726
- 试验地点
- 2
- 主要终点
- change in somatic and psychic anxiety symptoms
研究概览
简要总结
PROTECT-AD is a cognitive behavioral treatment study involving highly qualified psychotherapeutic centers at seven German universities.
It is our goal to further investigate and optimize existing effective treatments of anxiety disorders. In order to achieve this, the investigators want to investigate the effect of extinction learning in an "intensified" psychological intervention on treatment outcome in adults and children with anxiety disorders.
The intensified psychological intervention is characterized by a higher number of exposure trials over a short time period. In the control condition the exposure trials take place in a weekly interval, analog to standard care.
详细描述
Novel preclinical research evidence suggests extinction learning as the core mechanism of action of exposure-based therapies and provides according strategies to improve the effectiveness of treatment by optimized extinction. A translational research agenda is suggested to examine whether enhanced extinction learning components derived from preclinical research, applied within an "intensified" exposure-based treatment, improves outcomes. In a multicenter randomized clinical trial, linked to mechanistic subprojects, the investigators test in n=620 patients with primary AD allowing for comorbidity whether intensified psychological interventions based on augmented extinction learning (IPI) result in faster, stronger and more persistent outcomes on subjective, clinical, behavioral, physiological and neural indices as compared to an, otherwise identical, standard research treatment without explicit enhanced extinction (TAU). The investigators hypothesize that (a) enhanced extinction elements (IPI) will result in higher effect sizes, faster recovery, (b) more pronounced changes in an array of systems, including elements of extinction learning and in objective behavioral measures assessed in intersession exposure trials. The investigators also examine moderators of outcome (i.e. type of diagnosis, comorbidity) and explore whether IPI is associated with lower health care costs.
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
- None
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 15 - 70 years
- •one or more of the following DSM-IV/5 anxiety disorders: Panic Disorder, Agoraphobia, Social Anxiety Disorder, Specific Phobia
- •HAMA - Score > 18
- •CGI - Score > 3
- •Can attend therapy regularly (with or without support)
- •Informed Consent
排除标准
- •Every reason the protocol may not be upheld (e.g. planned hospitalization within study time frame, planning to move away, etc.)
- •Current suicidal tendency
- •DSM-5 Bipolar Disorder
- •DSM-5 Psychotic Disorder
- •DSM-5 Borderline Personality Disorder
- •Current treatment of other mental disorder (drugs, psychotherapy)
- •Current Alcohol, Benzodiazepine or other Substance Use Disorders
- •Severe medical illness/condition (every serious physical illness, including cardiovascular, kidney, endocrinological and neurological conditions, Hepatitis or other clinical findings that suggest a severe illness and may affect participation in the study)
研究组 & 干预措施
Intensified Psychological Intervention
Intensified psychological intervention (Cognitive Behavioral Therapy), based on optimized extinction learning
干预措施: Intensified psychological intervention (Behavioral)
Treatment As Usual
Standard intervention (Cognitive Behavioral Therapy) without optimized extinction learning
干预措施: Standard intervention (Behavioral)
结局指标
主要结局
change in somatic and psychic anxiety symptoms
时间窗: assessed three times: Baseline, Post (1 week after end of therapy) and Follow up (6 months after end of therapy)
Anxiety symptoms are assessed using the clinician-rated Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A for the HAMA). Stronger, faster and more persistent reduction of anxiety symptoms in the IPI group than in the TAU group is expected.
次要结局
- change in screened anxiety symptoms(assessed fivetimes: Baseline, therapy session 4 (week 2 of therapy), therapy session 11 (week 5 to week 9 of therapy), Post (1 week after end of therapy) and Follow Up (6 months after end of therapy))
- change in severity of the anxiety disorder(assessed five times: Baseline, therapy session 4 (week 2 of therapy), therapy session 11 (week 5 to week 9 of therapy), Post (1 week after end of therapy) and Follow Up (6 months after end of therapy))
- change in categorial diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV/5)(assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy))
- change in depressive symptoms(assessed fivetimes: Baseline, therapy session 4 (week 2 of therapy), therapy session 11 (week 5 to week 9 of therapy), Post (1 week after end of therapy) and Follow Up (6 months after end of therapy))
- change in anxiety sensitivity(assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy))
- change in social anxiety(assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy))
- change in Specific Phobia symptoms(assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy))
- change in quality of life(assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy))
- fear of body sensations(assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy))
- change in panic and agoraphobic symptoms(assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy))
- change in agoraphobic avoidance(assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy))
- change in symptoms of Generalized Anxiety Disorder(assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy))
- change in agoraphobic cognitions(assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy))
- change in disability(assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy))
- change in psychopathological symptoms(assessed seven times: Baseline, therapy sessions 2 (week 1 of therapy), 4 (week 2), 7 (week 3 to 5), 10 (week 4 to 8), 11 (week 5 to 9), 12 (week 6 to 10) Post (1 week after end of therapy) and Follow Up (6 months after end of therapy))