Clinical Trials Directory

Trials / Completed

CompletedNCT03061448

Internet-based Exposure Therapy for Panic Disorder

Internet-based Exposure Therapy for Panic Disorder: A Randomized Controlled Pilot Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
61 (actual)
Sponsor
Karolinska Institutet · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
BEHAVIORALInternet-based cognitive-behavior therapyInternet-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.

Timeline

Start date
2017-02-01
Primary completion
2017-06-01
Completion
2017-06-01
First posted
2017-02-23
Last updated
2017-08-22

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT03061448. Inclusion in this directory is not an endorsement.