Panic Disorder With Agoraphobia
Conditions
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
Interventions
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.
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Panic Disorder Severity Scale - Self rated (PDSS-SR) | Week 0, Week 8 | Change in panic symptoms from baseline to Week 8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Client Satisfaction Questionnaire (CSQ) | Week 8 | To assess client satisfaction with treatment |
| Adverse events scale | Week 8 | To assess any adverse events caused by the treatment |
| Patient Health Questionnaire (PHQ-9) | Week 0, Week 8 | Change in depression from baseline to Week 8 |
| Anxiety Sensitivity Index (ASI) | Week 0, Week 8 | Change in fear of anxiety-related physical sensations |
| Agoraphobic Cognitions Questionnaire (ACQ) | Week 0, Week 8 | Change in fear of fear in agoraphobics |
| Credibility/Expectancy Questionnaire (CEQ) | Week 2 | Measuring treatment expectancy and rationale credibility for use in clinical outcome studies |
| Brunnsviken Quality of Life Questionnaire (BBQ) | 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) | Week 0, Week 8 | Change in functioning and disability |
| Generalised Anxiety Disorder Assessment (GAD-7) | Week 0, Week 8 | Screening tool and severity measure for generalised anxiety disorder |
| The Cardiac Anxiety Questionnaire (CAQ) | Week 0, Week 8 | Change in heart-focused anxiety from baseline to week 8 |
| HA-NI-SSD Symptom Preoccupation Scale - testversion (SPSt) | Week 0, Week 8 | Change in preoccupation of symptoms from baseline to week 8 |
| Body Sensations Questionnaire (BSQ) | Week 0, Week 8 | Change in fear of bodily sensations in agoraphobics |
Countries
Sweden
Outcome results
None listed