Panic DisorderNCT03233542
The Association Between Physical Sensations and Thinking Styles
A study testing Cognitive Behaviour Therapy in people with Panic Disorder, run by Ruhr University of Bochum at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Panic Disorder
- What is being tested?
- Cognitive Behaviour Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteGermany
- Study dates
- 18 Sep 2017to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- Serious medical disorders/ findings
- Other primary treatment diagnosis
- Intellectual impairment (estimated during screening)
- ADHD (estimated during screening)
- Personality disorders
Trial locations and contacts
1 site in 1 country.
Germany1 site
Psychotherapy Centre, Department of Clinical Psychology and Psychotherapy, Ruhr-Universität Bochum
Bochum, North Rhine-Westphalia, 44787
About this study
Official title: The Association Between Physical Sensations and Thinking Styles [Der Zusammenhang Zwischen körperlichem Empfinden Und Denkstilen]
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.
Read the 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.
- Conditions
- Panic Disorder
- Being tested
- Cognitive Behaviour Therapy
- Keywords
- Cognitive biases, Associations, Interpretations, Physiological and biological markers
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behaviour TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Cognitive Behaviour Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
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").
Measured: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
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.
Measured: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
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".
Measured: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
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").
Measured: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
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.
Measured: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
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.
Measured: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
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.
Measured: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
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.
Measured: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Heart rate variability
An Electrocardiogram (ECG) will assess heart rate variability (HRV) during each testing session
Measured: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)t
Muscle activity
An Electromyography (EMG) will assess facial muscle activity during each testing session.
Measured: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
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.
Measured: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Galvanic skin response
Electrodermal activity (EDA), i.e., variations in the electrical characteristics of the skin, will be assessed during each testing session.
Measured: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
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.
Measured: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
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.
Measured: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start18 Sep 2017
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation, University of Oxford, University of Salzburg
- Responsible party
- Principal investigator, Marcella Woud, Ruhr University of Bochum
- Investigators
- Marcella L Woud, PhD, Principal investigator, Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233542
- Sponsor's protocol ID
- 145
- Other IDs
- WO2018/2-1, MA1116/13-1
- Status last verified
- Nov 2023
- First submitted
- 23 Jul 2017
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Physical Sensations and Thinking Styles [Der Zusammenhang Zwischen körperlichem Empfinden Und Denkstilen]
- ClinicalTrials.gov ID
- NCT03233542
- Acronym / sponsor ID
- 145
- Conditions
- Panic Disorder
- Keywords
- Cognitive biases, Associations, Interpretations, Physiological and biological markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Collaborators
- German Research Foundation, University of Oxford, University of Salzburg
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 28 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Panic Disorder: CBT | Experimental | Behavioral: Cognitive Behaviour TherapyParticipants 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. |
| 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 | Behavioral: Cognitive Behaviour TherapyAll 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behaviour TherapyCognitive 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. | Behavioural | Anxious Control Group: CBT, Panic Disorder: CBT |
Primary outcome
Priming Task
Time frame: 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.
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)
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.
Scrambled Sentences Test
Time frame: 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.
Interpretation Bias Questionnaire
Time frame: 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).
14 secondary outcomes
Anxiety Sensitivity Index (ASI)
Time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Depression Anxiety Stress Scale (DASS)
Time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Agoraphobic Cognitions Questionnaire (ACQ)
Time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Body Sensations Questionnaire (BSQ)
Time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Panic Disorder Severity Scale (PDSS)
Time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Mobility Inventory (MI)
Time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Subjective ratings DSM panic symptoms
Time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Responses Hyperventilation Task
Time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Heart rate variability
Time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)t
Muscle activity
Time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Respiration
Time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Galvanic skin response
Time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Cortisol
Time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Alpha amylase
Time frame: Pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcella L Woud, PhD principal investigator
Ruhr University of Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behaviour Therapy in people with Panic Disorder, run by Ruhr University of Bochum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Priming Task (time frame: Change from pre-treatment/waitinglist - post-treatment/waitinglist (post is approx. 3 months after the pre-treatment/waitinglist assessment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.