The Association Between Physical Sensations and Thinking Styles

NCT03233542 | Completed

• 3 other identifiers: 145WO2018/2-1MA1116/13-1
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Panic Disorder

Keywords

Cognitive biases; Associations; Interpretations; Physiological and biological markers

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (14)

• 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)

• Agoraphobic Cognitions Questionnaire (ACQ)

  Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)

• 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)

Study Arms (3)

Panic Disorder: CBT

EXPERIMENTAL

Participants with Panic Disorder randomized to this arm will receive a manualised Cognitive Behaviour Therapy (CBT) treatment for Panic Disorder, delivered in the outpatient psychotherapy centre of the Department of Clinical Psychology and Psychotherapy, Ruhr-Universität Bochum.

Behavioral: Cognitive Behaviour Therapy

Panic Disorder: Waiting list

NO INTERVENTION

After the pre-treatment testing session, participants with Panic Disorder randomized to this arm will wait a length of time equivalent to that for the pre/post-treatment duration for the Panic Disorder: Cognitive Behaviour Therapy arm (approx. 3 months), before returning to the post-treatment assessment. After completing all the study procedures, participants in this arm receive also the manualised Cognitive Behaviour Therapy treatment for Panic Disorder, delivered in the outpatient psychotherapy centre of the Department of Clinical Psychology and Psychotherapy, Ruhr-Universität Bochum.

Anxious Control Group: CBT

OTHER

All participants in the Anxious Control Group will receive a manualised Cognitive Behaviour Therapy (CBT) treatment for their diagnosed anxiety disorder, delivered in the outpatient psychotherapy centre of the Department of Clinical Psychology and Psychotherapy, Ruhr-Universität Bochum.

Behavioral: Cognitive Behaviour Therapy

Interventions

Cognitive Behaviour Therapy BEHAVIORAL

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.

Anxious Control Group: CBT; Panic Disorder: CBT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruhr University of Bochum: lead
• German Research Foundation: collaborator
• University of Oxford: collaborator
• University of Salzburg: collaborator

Study Sites (1)

Psychotherapy Centre, Department of Clinical Psychology and Psychotherapy, Ruhr-Universität Bochum

Bochum, North Rhine-Westphalia, 44787, Germany

Location

MeSH Terms

Conditions

Panic Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Marcella L Woud, PhD

  Ruhr University of Bochum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Fellow

Model Details: 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.

Study Record Dates

• First Submitted: July 23, 2017
• First Posted: July 28, 2017
• Study Start: September 18, 2017
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)