Clinical trial NCT03233542: The Association Between Physical Sensations and Thinking Styles
Official title: The Association Between Physical Sensations and Thinking Styles [Der Zusammenhang Zwischen körperlichem Empfinden Und Denkstilen]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Panic Disorder
Keywords: Cognitive biases
Associations
Interpretations
Physiological and biological markers
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
Collaborators: name: German Research Foundation
name: University of Oxford
name: University of Salzburg
First posted: 2017-07-28
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants meeting study criteria for Panic Disorder will be randomized to an intervention arm (CBT) or waiting list arm (which is followed by CBT after completion of the study procedures); participants meeting study criteria for the anxious control group will be allocated to an intervention (CBT) arm. The study aims to have equal numbers of participants in each of the 3 arms.
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Priming Task
timeFrame: Change from pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
measure: Single Target Association Test
timeFrame: Change from pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
measure: Scrambled Sentences Test
timeFrame: Change from pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
measure: Interpretation Bias Questionnaire
timeFrame: Change from pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Secondary outcomes:
measure: Anxiety Sensitivity Index (ASI)
timeFrame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
measure: Depression Anxiety Stress Scale (DASS)
timeFrame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
measure: Agoraphobic Cognitions Questionnaire (ACQ)
timeFrame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
measure: Body Sensations Questionnaire (BSQ)
timeFrame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
measure: Panic Disorder Severity Scale (PDSS)
timeFrame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
measure: Mobility Inventory (MI)
timeFrame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
measure: Subjective ratings DSM panic symptoms
timeFrame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
measure: Responses Hyperventilation Task
timeFrame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
measure: Heart rate variability
timeFrame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)t
measure: Muscle activity
timeFrame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
measure: Respiration
timeFrame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
measure: Galvanic skin response
timeFrame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
measure: Cortisol
timeFrame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
measure: Alpha amylase
timeFrame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Psychotherapy Centre, Department of Clinical Psychology and Psychotherapy, Ruhr-Universität Bochum
state: North Rhine Westphalia
Study officials:
affiliation: Ruhr University of Bochum
name: Marcella L Woud, PhD
role: PRINCIPAL_INVESTIGATOR
References: