Internet-Versus Group-Administered Cognitive Behavior Therapy for Panic Disorder (IP2)

February 17, 2009 updated by: Karolinska Institutet

Internet- Versus Group-Administered Cognitive Behavior Therapy for Panic Disorder in a Psychiatric Setting: A Randomized Equivalence Trial

Panic Disorder with or without agoraphobia (PD/A) is a common, and unless it is treated, often chronic psychiatric disorder. The are effective pharmacological as well as psychological treatments for PD/A. Because of the lack of availability of the most effective psychological treatment, cognitive behavior therapy (CBT), self-help based CBT treatments have been developed. One of those are Internet-based CBT. The aim of this study is to compare the effectiveness of Internet and group CBT for PD/A in a regular psychiatric setting. 113 patients are consecutively and randomly assigned to either treatment (both lasting 10 weeks). The main outcome measure is the Panic Disorder Severity Scale(PDSS). The study hypothesis is that treatments will show equal effectiveness.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 171 76
        • Karolinska Institutet, Department of Clinical Neuroscience, Section of psychiatry, Karolinska Hospital Solna R5

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary Panic Disorder with or without Agoraphobia (PD/A)

Exclusion Criteria:

  • active substance abuse
  • physiological etiology of panic symptoms
  • under 18 years of age
  • severe depression or suicidal ideation.
  • if on drugs for PD, not having had a constant dosage for 2 months
  • undergoing other cognitive behavioral treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Internet CBT
Internet-based cognitive behavior therapy (CBT).
Behavioral: Internet-based cognitive behavior therapy (CBT).
Self-help program and guidance by psychologist via e-mail during 10 weeks.
Experimental: Group CBT
Group cognitive behavior therapy (CBT).
Behavioral: Group CBT
Group cognitive behavior therapy (CBT) during 10 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Panic Disorder Severity Scale (PDSS)
Time Frame: Pre, post at 6-month follow-up
Pre, post at 6-month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Montgomery-Åsberg Depression Rating Scale (MADRS) Anxiety Sensitivity Index (ASI) Sheehan Disability Scale (SDS)
Time Frame: Pre, post and 6-month follow-up
Pre, post and 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Region Stockholm

Investigators

  • Principal Investigator: Nils Lindefors, MD, PhD, professor, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

February 17, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (Estimate)

February 18, 2009

Study Record Updates

Last Update Posted (Estimate)

February 18, 2009

Last Update Submitted That Met QC Criteria

February 17, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IP2
  • Dnr 04-034/4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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