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Internet-based Exposure Therapy for Panic Disorder

Primary Purpose

Panic Disorder With Agoraphobia

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-based cognitive-behavior therapy
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Panic Disorder With Agoraphobia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska Institutet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Inhibitory learning based treatment

Habituation based treatment

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Panic Disorder Severity Scale - Self rated (PDSS-SR)
Change in panic symptoms from baseline to Week 8

Secondary Outcome Measures

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

Full Information

First Posted
February 19, 2017
Last Updated
August 17, 2017
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT03061448
Brief Title
Internet-based Exposure Therapy for Panic Disorder
Official Title
Internet-based Exposure Therapy for Panic Disorder: A Randomized Controlled Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
June 1, 2017 (Actual)
Study Completion Date
June 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder With Agoraphobia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik M Andersson, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
17177
Country
Sweden

12. IPD Sharing Statement

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Internet-based Exposure Therapy for Panic Disorder

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