Karolinska Institutet
Stockholm, 17177, Sweden
NCT Number: NCT03061448
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Stockholm, 17177, Sweden
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Internet-based cognitive-behavior therapy on a safe internet platform. Treatment is divided into eight modules, each containing homework assignments . The participants will be assigned a therapist that they can contact through a message system in the platform and expect answer within 24 hours.
Time frame: Week 0, Week 8
Change in panic symptoms from baseline to Week 8
Time frame: Week 2
Measuring treatment expectancy and rationale credibility for use in clinical outcome studies
Time frame: Week 8
To assess client satisfaction with treatment
Time frame: Week 8
To assess any adverse events caused by the treatment
Time frame: Week 0, Week 8
Change in depression from baseline to Week 8
Time frame: Week 0, Week 8
Change in fear of anxiety-related physical sensations
Time frame: Week 0, Week 8
Change in fear of fear in agoraphobics
Time frame: Week 0, Week 8
Change in fear of bodily sensations in agoraphobics
Time frame: Week 0, Week 8
Change in self-perceived quality of life from baseline to week 8
Time frame: Week 0, Week 8
Change in functioning and disability
Time frame: Week 0, Week 8
Screening tool and severity measure for generalised anxiety disorder
Time frame: Week 0, Week 8
Change in heart-focused anxiety from baseline to week 8
Time frame: Week 0, Week 8
Change in preoccupation of symptoms from baseline to week 8
Karolinska Institutet
Other
Internet-based Exposure Therapy for Panic Disorder: A Randomized Controlled Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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