The Association Between Physical Sensations and Thinking Styles [Der Zusammenhang Zwischen körperlichem Empfinden Und Denkstilen]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Single Target Association Test
研究概览
简要总结
The aim of the study is to examine panic-related associations and interpretations in the context of Panic Disorder and its treatment. While theoretical accounts of Panic Disorder suggest a central role of such associations and interpretations in the onset and maintenance of the disorder, research to date in fact leaves many questions about the nature of these dysfunctional cognitions and their potential role unanswered. Patients with Panic Disorder and a control group of patients with other anxiety disorders will complete measures of panic-relevant associations and interpretation bias. The patients with Panic Disorder will be randomized to receive either Cognitive Behaviour Therapy (CBT) or a waiting list condition (to be followed by CBT after completion of the study procedures). The anxious control group will also receive CBT. Panic-relevant associations and interpretations will be measured twice, i.e., pre and post CBT/waitlist. Furthermore, relevant symptom measures and physiological and biological markers will be assessed and responses to a hyperventilation challenge. The study aims to further advance our understanding of cognitions in the etiology and maintenance of Panic Disorder, and inform future treatment optimisation.
详细描述
The main purpose of the present study is to look at relationships and changes over time but not to compare treatment outcomes (i.e. it is not an efficacy trial). The associations and interpretation measures are listed as primary outcomes because these are the measures of main interest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •Aged 18 to 65
- •Primary DSM-5 Anxiety Disorder (Panic Disorder for Panic Disorder groups, other anxiety disorder for anxious control group)
- •Provided written informed consent
- •Patient is in principle able to take part in the therapy
- •Sufficient knowledge of German language
- •Outpatient (no parallel hospital stay)
- •Medical certificate: medical safety, so that hyperventilation is possible
排除标准
- •Any reason that jeopardises the performance of the therapy
- •Acute suicidality
- •Primary affective disorder (e.g. Bipolar I, Major Depression)
- •Psychotic disorder
- •Parallel psychiatric or psychotherapeutic treatment (acute treatment)
- •Current substance dependence (apart from Nicotine dependence)
- •Serious medical disorders/ findings
- •Other primary treatment diagnosis
- •Intellectual impairment (estimated during screening)
- •ADHD (estimated during screening)
- •Personality disorders
结局指标
主要结局
Single Target Association Test
时间窗: Change from pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
The Single Target Implicit Association Test (STIAT) measures the associative strength between a target concept and two attribute dimensions. Participants are asked to sort stimuli into three categories by means of two response keys: one category represents a target concept, and two categories represent two poles of an attribute dimension. The target category is paired with both attributes. The present STIAT is designed as follows: targets: bodily changes, attributes: alarming vs. meaningless, and it takes over the structure as suggested by Wigboldus et al. (2006): (a) attribute discrimination, (b) target categorization practice, (c) first combined block, (d) reversed target categorization practice, and (e) reversed combined block.
Interpretation Bias Questionnaire
时间窗: Change from pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
The Interpretation Bias Questionnaire (IBQ) measures panic-related interpretation biases. It consists of 18 brief scenarios used in earlier studies (Ebert, 1993, Foa \& McNally, 1987). Nine items describe panic-related situations, and the other nine describe negative, threat-related situations. Following each scenario, three explanations are presented (for panic-related scenarios: one panic-related explanation and two panic-unrelated explanations, for negative, threat-related situations: one very negative, threat-related interpretation and two harmless explanations). Participants have to indicate how likely each explanation for the corresponding scenario is, using rating scale from 0 (not likely) to 100 (very likely).
Scrambled Sentences Test
时间窗: Change from pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
The Scrambled Sentence Task (SST, Wenzlaff \& Bates, 1998) measures panic-related interpretation biases. It consists of six-word strings participants are asked to unscramble to form a five-word sentence, leaving out one word. The present SST can be completed such that the resulting five-word sentences produce either a panic-related or neutral interpretation. During the SST, there is a cognitive load, i.e., participants have to memorize a 6 digit number.
Priming Task
时间窗: Change from pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
The Priming Paradigm measures panic related associations. During this task, participants will be instructed to sort target words as words versus non-words (lexical decision task). Before a target appears, however, a prime will be presented. Participants will be instructed to look at the prime but to not react to it. Following the design of Hermans et al. (2010), we will use the following prime-target combinations: panic-panic, panic-neutral, neutral-neutral, neutral-panic. There will also be prime-target combinations with non-words as targets.
次要结局
- Agoraphobic Cognitions Questionnaire (ACQ)(Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment))
- Mobility Inventory (MI)(Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment))
- Subjective ratings DSM panic symptoms(Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment))
- Heart rate variability(Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)t)
- Body Sensations Questionnaire (BSQ)(Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment))
- Panic Disorder Severity Scale (PDSS)(Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment))
- Anxiety Sensitivity Index (ASI)(Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment))
- Depression Anxiety Stress Scale (DASS)(Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment))
- Muscle activity(Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment))
- Responses Hyperventilation Task(Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment))
- Respiration(Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment))
- Galvanic skin response(Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment))
- Alpha amylase(Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment))
- Cortisol(Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment))
研究者
Marcella Woud
Postdoctoral Research Fellow
Ruhr University of Bochum