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

This study has been completed.
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00845260
First received: February 17, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Karolinska Institutet

Additional 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
Study First Received: February 17, 2009
Last Updated: February 17, 2009
Health Authority: Sweden: Regional Ethical Review Board

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

ClinicalTrials.gov processed this record on November 25, 2014