Clinical trial NCT03061448: Internet-based Exposure Therapy for Panic Disorder
Official title: Internet-based Exposure Therapy for Panic Disorder: A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Panic Disorder With Agoraphobia
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* Outpatients
* ≥ 18 years
* Situated in Sweden
* Informed consent
* Panic Disorder Severity Scale - self rated score more than 6 points

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

Primary outcomes:
measure: Panic Disorder Severity Scale - Self rated (PDSS-SR)
timeFrame: Week 0, Week 8
Secondary outcomes:
measure: Credibility/Expectancy Questionnaire (CEQ)
timeFrame: Week 2
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: Week 8
measure: Adverse events scale
timeFrame: Week 8
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Week 0, Week 8
measure: Anxiety Sensitivity Index (ASI)
timeFrame: Week 0, Week 8
measure: Agoraphobic Cognitions Questionnaire (ACQ)
timeFrame: Week 0, Week 8
measure: Body Sensations Questionnaire (BSQ)
timeFrame: Week 0, Week 8
measure: Brunnsviken Quality of Life Questionnaire (BBQ)
timeFrame: Week 0, Week 8
measure: WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: Week 0, Week 8
measure: Generalised Anxiety Disorder Assessment (GAD-7)
timeFrame: Week 0, Week 8
measure: The Cardiac Anxiety Questionnaire (CAQ)
timeFrame: Week 0, Week 8
measure: HA-NI-SSD Symptom Preoccupation Scale - testversion (SPSt)
timeFrame: Week 0, Week 8
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Erik M Andersson, PhD
role: PRINCIPAL_INVESTIGATOR
References: