Back to resultsInternet-Versus Group-Administered Cognitive Behavior Therapy for Panic Disorder (IP2)
Primary Purpose
Panic Disorder
Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Internet-based cognitive behavior therapy (CBT).
Group CBT
Sponsored by
About this trial
This is an interventional treatment trial for Panic Disorder
Eligibility 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
Sites / Locations
- Karolinska Institutet, Department of Clinical Neuroscience, Section of psychiatry, Karolinska Hospital Solna R5
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Internet CBT
Group CBT
Arm Description
Internet-based cognitive behavior therapy (CBT).
Group cognitive behavior therapy (CBT).
Outcomes
Primary Outcome Measures
Panic Disorder Severity Scale (PDSS)
Secondary Outcome Measures
Montgomery-Åsberg Depression Rating Scale (MADRS) Anxiety Sensitivity Index (ASI) Sheehan Disability Scale (SDS)
Full Information
NCT ID
NCT00845260
First Posted
February 17, 2009
Last Updated
February 17, 2009
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
1. Study Identification
Unique Protocol Identification Number
NCT00845260
Brief Title
Internet-Versus Group-Administered Cognitive Behavior Therapy for Panic Disorder
Acronym
IP2
Official Title
Internet- Versus Group-Administered Cognitive Behavior Therapy for Panic Disorder in a Psychiatric Setting: A Randomized Equivalence Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet CBT
Arm Type
Experimental
Arm Description
Internet-based cognitive behavior therapy (CBT).
Arm Title
Group CBT
Arm Type
Experimental
Arm Description
Group cognitive behavior therapy (CBT).
Intervention Type
Behavioral
Intervention Name(s)
Internet-based cognitive behavior therapy (CBT).
Intervention Description
Self-help program and guidance by psychologist via e-mail during 10 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Group CBT
Intervention Description
Group cognitive behavior therapy (CBT) during 10 weeks.
Primary Outcome Measure Information:
Title
Panic Disorder Severity Scale (PDSS)
Time Frame
Pre, post at 6-month follow-up
Secondary Outcome Measure Information:
Title
Montgomery-Åsberg Depression Rating Scale (MADRS) Anxiety Sensitivity Index (ASI) Sheehan Disability Scale (SDS)
Time Frame
Pre, post and 6-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nils Lindefors, MD, PhD, professor
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet, Department of Clinical Neuroscience, Section of psychiatry, Karolinska Hospital Solna R5
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
21110842
Citation
Lonsdorf TB, Ruck C, Bergstrom 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. doi: 10.1186/1471-244X-10-99.
Results Reference
derived
PubMed Identifier
20598127
Citation
Bergstrom J, Andersson G, Ljotsson B, Ruck C, Andreewitch 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. doi: 10.1186/1471-244X-10-54.
Results Reference
derived
Learn more about this trial
Internet-Versus Group-Administered Cognitive Behavior Therapy for Panic Disorder
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