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:

MedlinePlus related topics: Anxiety Panic Disorder

U.S. FDA Resources

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

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):

Lonsdorf TB, Rück C, Bergström J, Andersson G, Ohman A, Lindefors N, Schalling M. The COMTval158met polymorphism is associated with symptom relief during exposure-based cognitive-behavioral treatment in panic disorder. BMC Psychiatry. 2010 Nov 26;10:99.

Bergström J, Andersson G, Ljótsson B, Rück C, Andréewitch S, Karlsson A, Carlbring P, Andersson E, Lindefors N. Internet-versus group-administered cognitive behaviour therapy for panic disorder in a psychiatric setting: a randomised trial. BMC Psychiatry. 2010 Jul 2;10:54.

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:

Panic Disorder
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013

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