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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00845260
First Posted: February 18, 2009
Last Update Posted: February 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Stockholm County Council, Sweden
Information provided by:
Karolinska Institutet
  Purpose
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.

Condition Intervention Phase
Panic Disorder Behavioral: Internet-based cognitive behavior therapy (CBT). Behavioral: Group CBT Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Internet- Versus Group-Administered Cognitive Behavior Therapy for Panic Disorder in a Psychiatric Setting: A Randomized Equivalence Trial

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Panic Disorder Severity Scale (PDSS) [ Time Frame: Pre, post at 6-month follow-up ]

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

Enrollment: 113
Study Start Date: December 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00845260


Locations
Sweden
Karolinska Institutet, Department of Clinical Neuroscience, Section of psychiatry, Karolinska Hospital Solna R5
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
Investigators
Principal Investigator: Nils Lindefors, MD, PhD, professor Karolinska Institutet
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nils Lindefors, MD, PHD, professor, Karolinska Institutet, Stockholm County Council
ClinicalTrials.gov Identifier: NCT00845260     History of Changes
Other Study ID Numbers: IP2
Dnr 04-034/4
First Submitted: February 17, 2009
First Posted: February 18, 2009
Last Update Posted: February 18, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Disease
Panic Disorder
Pathologic Processes
Anxiety Disorders
Mental Disorders