<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03233542</url>
  </required_header>
  <id_info>
    <org_study_id>145</org_study_id>
    <secondary_id>WO2018/2-1</secondary_id>
    <secondary_id>MA1116/13-1</secondary_id>
    <nct_id>NCT03233542</nct_id>
  </id_info>
  <brief_title>The Association Between Physical Sensations and Thinking Styles</brief_title>
  <official_title>The Association Between Physical Sensations and Thinking Styles [Der Zusammenhang Zwischen körperlichem Empfinden Und Denkstilen]</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ruhr University of Bochum</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>German Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Salzburg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ruhr University of Bochum</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to examine panic-related associations and interpretations in the&#xD;
      context of Panic Disorder and its treatment. While theoretical accounts of Panic Disorder&#xD;
      suggest a central role of such associations and interpretations in the onset and maintenance&#xD;
      of the disorder, research to date in fact leaves many questions about the nature of these&#xD;
      dysfunctional cognitions and their potential role unanswered. Patients with Panic Disorder&#xD;
      and a control group of patients with other anxiety disorders will complete measures of&#xD;
      panic-relevant associations and interpretation bias. The patients with Panic Disorder will be&#xD;
      randomized to receive either Cognitive Behaviour Therapy (CBT) or a waiting list condition&#xD;
      (to be followed by CBT after completion of the study procedures). The anxious control group&#xD;
      will also receive CBT. Panic-relevant associations and interpretations will be measured&#xD;
      twice, i.e., pre and post CBT/waitlist. Furthermore, relevant symptom measures and&#xD;
      physiological and biological markers will be assessed and responses to a hyperventilation&#xD;
      challenge. The study aims to further advance our understanding of cognitions in the etiology&#xD;
      and maintenance of Panic Disorder, and inform future treatment optimisation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main purpose of the present study is to look at relationships and changes over time but&#xD;
      not to compare treatment outcomes (i.e. it is not an efficacy trial). The associations and&#xD;
      interpretation measures are listed as primary outcomes because these are the measures of main&#xD;
      interest.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 18, 2017</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Priming Task</measure>
    <time_frame>Change from pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Single Target Association Test</measure>
    <time_frame>Change from pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Scrambled Sentences Test</measure>
    <time_frame>Change from pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)</time_frame>
    <description>The Scrambled Sentence Task (SST, Wenzlaff &amp; 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interpretation Bias Questionnaire</measure>
    <time_frame>Change from pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)</time_frame>
    <description>The Interpretation Bias Questionnaire (IBQ) measures panic-related interpretation biases. It consists of 18 brief scenarios used in earlier studies (Ebert, 1993, Foa &amp; 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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety Sensitivity Index (ASI)</measure>
    <time_frame>Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)</time_frame>
    <description>The ASI (Ehlers, 1986; Reiss, Peterson, &amp; McNally, 1986) is a 16-item self-report questionnaire measuring fear and concerns regarding anxiety-related symptoms such as &quot;It scares me when my heart beats rapidly&quot;. Items are rated on a five-point Likert scale (0 = &quot;Very little&quot; to 4 = &quot;Very much&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression Anxiety Stress Scale (DASS)</measure>
    <time_frame>Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)</time_frame>
    <description>The DASS-21 (Lovibond &amp; Lovibond, 1995; Nilges &amp; Essau, 2015) questionnaire comprises three 7-item subscales assessing levels of depression, anxiety, and stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Agoraphobic Cognitions Questionnaire (ACQ)</measure>
    <time_frame>Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)</time_frame>
    <description>The ACQ (Chambless, Caputo, Bright, &amp; Gallagher, 1984; Ehlers, Margraf, &amp; 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, &quot;loss of control&quot; and &quot;physical concerns&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Sensations Questionnaire (BSQ)</measure>
    <time_frame>Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)</time_frame>
    <description>The BSQ (Chambless, Caputo, Bright, &amp; Gallagher, 1984; Ehlers, Margraf, &amp; 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 = &quot;Not at all&quot; to 5 = &quot;Extremely&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Panic Disorder Severity Scale (PDSS)</measure>
    <time_frame>Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mobility Inventory (MI)</measure>
    <time_frame>Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)</time_frame>
    <description>The MI (Chambless, Caputo, Jasin, Gracely, &amp; Williams, 1985, Ehlers, Margraf, &amp; Chambless, 1993) consists of 26 items and measures agoraphobic avoidance using a five-point Likert scale (1 = &quot;Never avoid&quot; to 5 = &quot;Always avoid&quot;). Each item has to be answered twice, once for when being accompanied and once for when being alone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective ratings DSM panic symptoms</measure>
    <time_frame>Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)</time_frame>
    <description>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, &amp; 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Responses Hyperventilation Task</measure>
    <time_frame>Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)</time_frame>
    <description>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.&#xD;
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).&#xD;
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.&#xD;
Phase 3: This is a 3 minute recovery phase. During this phase, participants are supposed to breath normally again.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)t</time_frame>
    <description>An Electrocardiogram (ECG) will assess heart rate variability (HRV) during each testing session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle activity</measure>
    <time_frame>Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)</time_frame>
    <description>An Electromyography (EMG) will assess facial muscle activity during each testing session.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiration</measure>
    <time_frame>Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Galvanic skin response</measure>
    <time_frame>Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)</time_frame>
    <description>Electrodermal activity (EDA), i.e., variations in the electrical characteristics of the skin, will be assessed during each testing session.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cortisol</measure>
    <time_frame>Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alpha amylase</measure>
    <time_frame>Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">114</enrollment>
  <condition>Panic Disorder</condition>
  <arm_group>
    <arm_group_label>Panic Disorder: CBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panic Disorder: Waiting list</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anxious Control Group: CBT</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behaviour Therapy</intervention_name>
    <description>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.</description>
    <arm_group_label>Anxious Control Group: CBT</arm_group_label>
    <arm_group_label>Panic Disorder: CBT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 to 65&#xD;
&#xD;
          -  Primary DSM-5 Anxiety Disorder (Panic Disorder for Panic Disorder groups, other&#xD;
             anxiety disorder for anxious control group)&#xD;
&#xD;
          -  Provided written informed consent&#xD;
&#xD;
          -  Patient is in principle able to take part in the therapy&#xD;
&#xD;
          -  Sufficient knowledge of German language&#xD;
&#xD;
          -  Outpatient (no parallel hospital stay)&#xD;
&#xD;
          -  Medical certificate: medical safety, so that hyperventilation is possible&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any reason that jeopardises the performance of the therapy&#xD;
&#xD;
          -  Acute suicidality&#xD;
&#xD;
          -  Primary affective disorder (e.g. Bipolar I, Major Depression)&#xD;
&#xD;
          -  Psychotic disorder&#xD;
&#xD;
          -  Parallel psychiatric or psychotherapeutic treatment (acute treatment)&#xD;
&#xD;
          -  Current substance dependence (apart from Nicotine dependence)&#xD;
&#xD;
          -  Serious medical disorders/ findings&#xD;
&#xD;
          -  Other primary treatment diagnosis&#xD;
&#xD;
          -  Intellectual impairment (estimated during screening)&#xD;
&#xD;
          -  ADHD (estimated during screening)&#xD;
&#xD;
          -  Personality disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcella L Woud, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ruhr University of Bochum</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marcella L Woud, PhD</last_name>
    <phone>+492343221502</phone>
    <email>marcella.woud@rub.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lisa Zahler, MSc</last_name>
    <phone>+492343227939</phone>
    <email>lisa.zahler@rub.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Psychotherapy Centre, Department of Clinical Psychology and Psychotherapy, Ruhr-Universität Bochum</name>
      <address>
        <city>Bochum</city>
        <state>North Rhine Westphalia</state>
        <zip>44787</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marcella L Woud, PhD</last_name>
      <phone>+492343221502</phone>
      <email>marcella.woud@rub.de</email>
    </contact>
    <contact_backup>
      <last_name>Lisa Zahler, MSc</last_name>
      <phone>+492343227939</phone>
      <email>lisa.zahler@rub.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>April 25, 2022</last_update_submitted>
  <last_update_submitted_qc>April 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ruhr University of Bochum</investigator_affiliation>
    <investigator_full_name>Marcella Woud</investigator_full_name>
    <investigator_title>Postdoctoral Research Fellow</investigator_title>
  </responsible_party>
  <keyword>Cognitive biases</keyword>
  <keyword>Associations</keyword>
  <keyword>Interpretations</keyword>
  <keyword>Physiological and biological markers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Panic Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>It is planned to make individual participant data available on publication of the associated study results, via a publically-available data repository such as Open Science Framework. Data made available will be the research data reported in the publication, with the exception of any data that could compromise participant anonymity.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03233542
org study id: 145
secondary id: WO2018/2-1
secondary id: MA1116/13-1
nct id: NCT03233542
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
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
masking: None (Open Label)
measure: Priming Task
time frame: Change from pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
description: 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.
measure: Single Target Association Test
time frame: Change from pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
description: 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.
measure: Scrambled Sentences Test
time frame: Change from pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
description: 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.
measure: Interpretation Bias Questionnaire
time frame: Change from pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
description: 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).
measure: Anxiety Sensitivity Index (ASI)
time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
description: 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").
measure: Depression Anxiety Stress Scale (DASS)
time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
description: The DASS-21 (Lovibond & Lovibond, 1995; Nilges & Essau, 2015) questionnaire comprises three 7-item subscales assessing levels of depression, anxiety, and stress.
measure: Agoraphobic Cognitions Questionnaire (ACQ)
time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
description: 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".
measure: Body Sensations Questionnaire (BSQ)
time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
description: 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").
measure: Panic Disorder Severity Scale (PDSS)
time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
description: 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.
measure: Mobility Inventory (MI)
time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
description: 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.
measure: Subjective ratings DSM panic symptoms
time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
description: 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.
measure: Responses Hyperventilation Task
time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
description: 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.
measure: Heart rate variability
time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)t
description: An Electrocardiogram (ECG) will assess heart rate variability (HRV) during each testing session
measure: Muscle activity
time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
description: An Electromyography (EMG) will assess facial muscle activity during each testing session.
measure: Respiration
time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
description: 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.
measure: Galvanic skin response
time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
description: Electrodermal activity (EDA), i.e., variations in the electrical characteristics of the skin, will be assessed during each testing session.
measure: Cortisol
time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
description: 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.
measure: Alpha amylase
time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
description: 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.
arm group label: Panic Disorder: CBT
arm group type: Experimental
description: 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.
arm group label: Panic Disorder: Waiting list
arm group type: No Intervention
description: 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.
arm group label: Anxious Control Group: CBT
arm group type: Other
description: 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.
intervention type: Behavioral
intervention name: Cognitive Behaviour Therapy
description: 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.
arm group label: Anxious Control Group: CBT
arm group label: Panic Disorder: CBT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Marcella L Woud, PhD
role: Principal Investigator
affiliation: Ruhr University of Bochum
last name: Marcella L Woud, PhD
phone: +492343221502
email: marcella.woud@rub.de
last name: Lisa Zahler, MSc
phone: +492343227939
email: lisa.zahler@rub.de
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Ruhr University of Bochum
investigator full name: Marcella Woud
investigator title: Postdoctoral Research Fellow
mesh term: Panic Disorder
sharing ipd: Yes
ipd description: It is planned to make individual participant data available on publication of the associated study results, via a publically-available data repository such as Open Science Framework. Data made available will be the research data reported in the publication, with the exception of any data that could compromise participant anonymity.