Internet-based Exposure Therapy for Panic Disorder

Not Applicable

Completed

Brief Summary: The purpose of this study is examine if an internet-based exposure therapy based on inhibitory learning is feasible, acceptable and effective in reducing panic symptoms amongst patients who suffer from panic disorder and agoraphobia.

Detailed Description: Trial objectives: Primary objective is to examine if an internet-based exposure therapy based on inhibitory learning is effective in reducing panic symptoms. The secondary objective is to study if the protocol is feasible and acceptable. Secondary objective is measured is examined on 1) number of participants completing the study protocol, 2) participants' satisfaction with the treatment, 3) therapists' ratings of acceptability. The aim of this study is to assess the feasibility, and pilot the design and delivery of a RCT that will subsequently form the framework for a larger RCT to evaluate the effectiveness of an exposure protocol based on inhibitory learning.

Trial Design: Randomized controlled pilot study with two groups randomly assigned to either Internet-based exposure therapy based on the principles of inhibitory learning or Internet-based exposure therapy based on the principles of habituation Duration: Eight weeks Primary Endpoint: Change in panic symptoms from baseline to Week 8. Efficacy Parameters: Panic Disorder Severity Scale - Self rated (PDSS-SR) Safety Parameters: Adverse Events is assessed weekly via the internet. Description of Trial Subjects: Patients \> 18 years old with a PDSS-SR score more than 6 points Number of Subjects: 80

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Substance dependence during the last six months
Post traumatic stress disorder, bipolar disorder or psychosis
Symptoms better explained by axis 2 diagnosis (e.g. autism or borderline personality disorder)
MADRS-S score above 25 points
Psychotropic medication changes within one months prior to treatment that could affect target symptoms.
Received exposure based Cognitive behavior therapy (CBT) for pathological worry the last 2 years

Arm && Interventions

Group	Intervention	Description
Inhibitory learning based treatment	Internet-based cognitive-behavior therapy	The experimental group will go through Internet-based treatment. The exposure treatment is 8 weeks long and based on the principles of inhibitory learning, i.e. the participant is instructed to stay in the frightening situation until his/her expectancy has been maximally violated.
Habituation based treatment	Internet-based cognitive-behavior therapy	The active comparator group will also go through Internet-based treatment. The exposure treatment is 8 weeks long and based on the principles of emotional processing theory, i.e. the participant is instructed to stay in the frightening situation until anxiety has declined (habituated).

Primary Outcome Measures

Name	Time	Method
Panic Disorder Severity Scale - Self rated (PDSS-SR)	Week 0, Week 8	Change in panic symptoms from baseline to Week 8

Secondary Outcome Measures

Name	Time	Method
Client Satisfaction Questionnaire (CSQ)	Week 8	To assess client satisfaction with treatment
Anxiety Sensitivity Index (ASI)	Week 0, Week 8	Change in fear of anxiety-related physical sensations
Patient Health Questionnaire (PHQ-9)	Week 0, Week 8	Change in depression from baseline to Week 8
HA-NI-SSD Symptom Preoccupation Scale - testversion (SPSt)	Week 0, Week 8	Change in preoccupation of symptoms from baseline to week 8
Body Sensations Questionnaire (BSQ)	Week 0, Week 8	Change in fear of bodily sensations in agoraphobics
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)	Week 0, Week 8	Change in functioning and disability
Adverse events scale	Week 8	To assess any adverse events caused by the treatment
Credibility/Expectancy Questionnaire (CEQ)	Week 2	Measuring treatment expectancy and rationale credibility for use in clinical outcome studies
Brunnsviken Quality of Life Questionnaire (BBQ)	Week 0, Week 8	Change in self-perceived quality of life from baseline to week 8
Agoraphobic Cognitions Questionnaire (ACQ)	Week 0, Week 8	Change in fear of fear in agoraphobics
Generalised Anxiety Disorder Assessment (GAD-7)	Week 0, Week 8	Screening tool and severity measure for generalised anxiety disorder
The Cardiac Anxiety Questionnaire (CAQ)	Week 0, Week 8	Change in heart-focused anxiety from baseline to week 8