An interventional study of Internet-based cognitive-behavior therapy in Panic Disorder With Agoraphobia, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-22.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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.
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
250 studies on the registry are indexed under Panic Disorder; 35 are open to participants now.
This study's enrollment of 61 is below the median of 80 across 195 interventional studies indexed under Panic Disorder.
Browse Panic Disorder studies →Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: 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).
Behavioral: Internet-based cognitive-behavior therapy
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.
Panic Disorder Severity Scale - Self rated (PDSS-SR)
Change in panic symptoms from baseline to Week 8
Time frame: Week 0, Week 8
Credibility/Expectancy Questionnaire (CEQ)
Measuring treatment expectancy and rationale credibility for use in clinical outcome studies
Time frame: Week 2
Client Satisfaction Questionnaire (CSQ)
To assess client satisfaction with treatment
Time frame: Week 8
Adverse events scale
To assess any adverse events caused by the treatment
Time frame: Week 8
Patient Health Questionnaire (PHQ-9)
Change in depression from baseline to Week 8
Time frame: Week 0, Week 8
Anxiety Sensitivity Index (ASI)
Change in fear of anxiety-related physical sensations
Time frame: Week 0, Week 8
Agoraphobic Cognitions Questionnaire (ACQ)
Change in fear of fear in agoraphobics
Time frame: Week 0, Week 8
Body Sensations Questionnaire (BSQ)
Change in fear of bodily sensations in agoraphobics
Time frame: Week 0, Week 8
Brunnsviken Quality of Life Questionnaire (BBQ)
Change in self-perceived quality of life from baseline to week 8
Time frame: Week 0, Week 8
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Change in functioning and disability
Time frame: Week 0, Week 8
Generalised Anxiety Disorder Assessment (GAD-7)
Screening tool and severity measure for generalised anxiety disorder
Time frame: Week 0, Week 8
The Cardiac Anxiety Questionnaire (CAQ)
Change in heart-focused anxiety from baseline to week 8
Time frame: Week 0, Week 8
HA-NI-SSD Symptom Preoccupation Scale - testversion (SPSt)
Change in preoccupation of symptoms from baseline to week 8
Time frame: Week 0, Week 8
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Karolinska Institutet