Internet-based Exposure Therapy for Panic Disorder

Panic Disorder With Agoraphobia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03061448
• Other study ID #: 2016/2422-31
• Status: Completed
• Phase: N/A
• First received: February 19, 2017
• Last updated: August 17, 2017
• Start date: February 1, 2017
• Est. completion date: June 1, 2017

Study information

• Verified date: August 2017
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 1, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Agoraphobia
• Disease
• Panic Disorder
• Panic Disorder With Agoraphobia

Intervention

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.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

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