Internet-based Exposure Therapy for Panic Disorder

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

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.

Study Overview

• Status: Completed
• Conditions: Panic Disorder With Agoraphobia
• Intervention / Treatment: Behavioral: Internet-based cognitive-behavior therapy

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

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 17177
    • Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inhibitory learning based treatment; 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; 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.
Active Comparator: Habituation based treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Panic Disorder Severity Scale - Self rated (PDSS-SR)	Change in panic symptoms from baseline to Week 8	Week 0, Week 8

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Erik M Andersson, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: February 19, 2017
• First Submitted That Met QC Criteria: February 19, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 17, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Panic Disorder; Agoraphobia
• Other Study ID Numbers: 2016/2422-31

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No