The Association Between Physical Sensations and Thinking Styles

Panic Disorder Clinical Trial

Official title:

The Association Between Physical Sensations and Thinking Styles [Der Zusammenhang Zwischen körperlichem Empfinden Und Denkstilen]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03233542
• Other study ID #: 145
• Secondary ID: WO2018/2-1MA1116
• Status: Completed
• Phase: N/A
• Start date: September 18, 2017
• Est. completion date: August 31, 2023

Study information

• Verified date: November 2023
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Panic Disorder

Intervention

Behavioral:
• Cognitive Behaviour Therapy
Cognitive Behaviour Therapy (CBT) for diagnosed anxiety disorder (i.e. CBT for Panic Disorder in the Panic Disorder group, or other diagnosed anxiety disorders in the Anxious Control group.

Locations

Country	Name	City	State
Germany	Psychotherapy Centre, Department of Clinical Psychology and Psychotherapy, Ruhr-Universität Bochum	Bochum	North Rhine Westphalia

Sponsors (4)

Lead Sponsor	Collaborator
Ruhr University of Bochum	German Research Foundation, University of Oxford, University of Salzburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Priming Task	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.	Change from pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Primary	Single Target Association Test	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.	Change from pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Primary	Scrambled Sentences Test	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.	Change from pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Primary	Interpretation Bias Questionnaire	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).	Change from pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Secondary	Anxiety Sensitivity Index (ASI)	The ASI (Ehlers, 1986; Reiss, Peterson, & McNally, 1986) is a 16-item self-report questionnaire measuring fear and concerns regarding anxiety-related symptoms such as "It scares me when my heart beats rapidly". Items are rated on a five-point Likert scale (0 = "Very little" to 4 = "Very much").	Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Secondary	Depression Anxiety Stress Scale (DASS)	The DASS-21 (Lovibond & Lovibond, 1995; Nilges & Essau, 2015) questionnaire comprises three 7-item subscales assessing levels of depression, anxiety, and stress.	Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Secondary	Agoraphobic Cognitions Questionnaire (ACQ)	The ACQ (Chambless, Caputo, Bright, & Gallagher, 1984; Ehlers, Margraf, & Chambless, 1993) measures maladaptive thoughts about the potential for disastrous consequences arising from anxiety or panic. It includes 14 items which can be scored as a total scale, or according to its two subscales, "loss of control" and "physical concerns".	Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Secondary	Body Sensations Questionnaire (BSQ)	The BSQ (Chambless, Caputo, Bright, & Gallagher, 1984; Ehlers, Margraf, & Chambless, 1993) includes 17 items that reflect specific bodily sensations (e.g., heart palpations, dizziness). Participants are asked to indicate the degree to which they experience anxiety related to these sensations by means of a five-point Likert scale (1 = "Not at all" to 5 = "Extremely").	Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Secondary	Panic Disorder Severity Scale (PDSS)	The PDSS (Shear et al., 1997) is a 7-item scale and provides a composite severity score of frequency, distress, and impairment associated with panic attacks.	Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Secondary	Mobility Inventory (MI)	The MI (Chambless, Caputo, Jasin, Gracely, & Williams, 1985, Ehlers, Margraf, & Chambless, 1993) consists of 26 items and measures agoraphobic avoidance using a five-point Likert scale (1 = "Never avoid" to 5 = "Always avoid"). Each item has to be answered twice, once for when being accompanied and once for when being alone.	Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Secondary	Subjective ratings DSM panic symptoms	A symptom checklist will assess the presence of panic-relevant symptomatology in line with the DSM-5 criteria for panic disorder, e.g., occurrence and frequency of panic attacks, experienced distress during panic attack, fear of going crazy, dizziness etc. (for a similar procedure, see Wilhelm, Gerlach, & Roth, 2001). It also assess participants' level of generally anxiety and whether or not participants experienced a panic attack. This will be completed repeatedly within each testing session.	Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Secondary	Responses Hyperventilation Task	An adapted version of the procedure described by Kossowsky, Wilhelm, and Schneider (2013) and Wilhelm et al. (2001) will be used in the present study. During the hyperventilation, participants will breathe through their nose and their breathing will be monitored by a capnograph. There will be 3 phases.; Phase 1: Participants will undergo a 'paced breathing' procedure. That is, they will be asked to keep a breathing speed of 18 cycles/minute (breaths per minute, bpm). Breathing speed will be paced by computerized audio instructions. At the end of phase 1, the end-tidal CO2 level should be 25mmHg (for recommendations for the end-tidal level, see Meuret et al., 2005).; Phase 2: The goal of this phase is to maintain the 25mmHg CO2 level while participants keep on breathing with a 18 bpm paced breathing pattern.; Phase 3: This is a 3 minute recovery phase. During this phase, participants are supposed to breath normally again.	Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Secondary	Heart rate variability	An Electrocardiogram (ECG) will assess heart rate variability (HRV) during each testing session	Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)t
Secondary	Muscle activity	An Electromyography (EMG) will assess facial muscle activity during each testing session.	Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Secondary	Respiration	Following recommendations of Ritz and Dahme (2006), the HRV assessment will be combined with a respiratory assessment. Respiration will be assessed by means of two plethysmography belts (thorax and abdomen) during each testing session.	Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Secondary	Galvanic skin response	Electrodermal activity (EDA), i.e., variations in the electrical characteristics of the skin, will be assessed during each testing session.	Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Secondary	Cortisol	Saliva samples will be collected at the start, during, and at the end of each testing session to analyze changes in cortisol levels, which serve as indices of arousal and stress.	Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Secondary	Alpha amylase	Saliva samples will be collected at the start, during, and at the end of each testing session to analyze changes in alpha amylase, which serve as indices of arousal and stress.	Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)