The Association Between Physical Sensations and Thinking Styles

NCT ID: NCT03233542

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-18
• Study Completion Date: 2023-08-31

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.

Conditions

Panic Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Panic Disorder: CBT

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.

Group Type: EXPERIMENTAL

Cognitive Behaviour Therapy

Intervention Type: 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.

Panic Disorder: Waiting list

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Anxious Control Group: CBT

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.

Group Type: OTHER

Cognitive Behaviour Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Research Foundation

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: collaborator

University of Salzburg

OTHER

Sponsor Role: collaborator

Ruhr University of Bochum

OTHER

Sponsor Role: lead

Responsible Party

Marcella Woud

Postdoctoral Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcella L Woud, PhD

Role: PRINCIPAL_INVESTIGATOR

Ruhr University of Bochum

Locations

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

Bochum, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

WO2018/2-1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MA1116/13-1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

145

Identifier Type: -

Identifier Source: org_study_id