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NCT00845260 Clinical Trial

Internet-Versus Group-Administered Cognitive Behavior Therapy for Panic Disorder

Panic Disorder Clinical Trial

— IP2  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00845260
Other study ID # IP2
Secondary ID Dnr 04-034/4
Status Completed
Phase Phase 3
First received February 17, 2009
Last updated February 17, 2009
Start date December 2004
Est. completion date December 2007

Study information
Verified date February 2009
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 113
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Internet-based cognitive behavior therapy (CBT).
Self-help program and guidance by psychologist via e-mail during 10 weeks.
• Group CBT
Group cognitive behavior therapy (CBT) during 10 weeks.

Locations
Country Name City State
Sweden Karolinska Institutet, Department of Clinical Neuroscience, Section of psychiatry, Karolinska Hospital Solna R5 Stockholm

Sponsors (2)
Lead Sponsor Collaborator
Karolinska Institutet Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Panic Disorder Severity Scale (PDSS) Pre, post at 6-month follow-up No
Secondary Montgomery-Åsberg Depression Rating Scale (MADRS) Anxiety Sensitivity Index (ASI) Sheehan Disability Scale (SDS) Pre, post and 6-month follow-up No
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