Clinical Trial: Internet-based Exposure Therapy for Panic Disorder

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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

Sponsor: Karolinska Institutet

Current Primary Outcome: Panic Disorder Severity Scale - Self rated (PDSS-SR) [ Time Frame: Week 0, Week 8 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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

Original Secondary Outcome: Same as current

Information By: Karolinska Institutet

Dates:
Date Received: February 19, 2017
Date Started: February 1, 2017
Date Completion: June 1, 2017
Last Updated: February 19, 2017
Last Verified: February 2017