The Association Between Physical Sensations and Thinking Styles

Ruhr University of Bochum

Status: Completed

Conditions: Panic Disorder

Treatments: Behavioral: Cognitive Behaviour Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03233542

MA1116/13-1 (Other Grant/Funding Number)

145

WO2018/2-1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 87 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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87 participants in 3 patient groups

Panic Disorder: CBT

Experimental group

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.

Treatment:

Behavioral: Cognitive Behaviour Therapy

Panic Disorder: Waiting list

No Intervention group

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.

Anxious Control Group: CBT

Other group

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.

Treatment:

Behavioral: Cognitive Behaviour Therapy