Treatment of Social Phobia and Panic Disorder in Adults (TSPPA)
Primary Purpose
Social Phobia, Panic Disorder
Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
individual cognitive-behavioural therapy
stepped care model
Sponsored by
About this trial
This is an interventional treatment trial for Social Phobia focused on measuring Cognitive therapy, Stepped care, Self-help, Internet, Anxiety
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnoses of panic disorder or social phobia
- Informed consent
Exclusion Criteria:
- Alcohol/drug dependency
- Major depressive disorder
- Psychosis
- Unstable medication
Sites / Locations
- haukelandUH
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Clinical Severity Ratings
Secondary Outcome Measures
Questionnaires: The Panic Attack Scale The Body Sensations Questionnaire The Agoraphobic Cognitions Questionnaire The Mobility Inventory for Agoraphobia Social Phobia Scale The Social Interaction Anxiety Scale
Full Information
NCT ID
NCT00619138
First Posted
January 16, 2008
Last Updated
January 25, 2016
Sponsor
Haukeland University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00619138
Brief Title
Treatment of Social Phobia and Panic Disorder in Adults
Acronym
TSPPA
Official Title
A Randomized, Controlled Study of a Stepped-care Model for the Treatment of Social Phobia and Panic Disorder in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Haukeland University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare a stepped care model for the treatment of social phobia and panic disorder with standard psychological treatment. The stepped care model comprises three steps: short psycho-education, a 10 weeks Internet-based self-help program, 12 weeks individual cognitive-behavioural therapy. Patients are assessed at each step and taken out of the study if they show significant clinical improvement and follow for 12 months. Patients are randomized to either the stepped care model or standard psychological treatment, i.e. individual cognitive-behavioural therapy. All treatment components are manualized.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Phobia, Panic Disorder
Keywords
Cognitive therapy, Stepped care, Self-help, Internet, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
174 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
individual cognitive-behavioural therapy
Intervention Description
1 session per week for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
stepped care model
Intervention Description
three steps: short psycho-education, a 10 weeks Internet-based self-help program, 12 weeks individual cognitive-behavioural therapy
Primary Outcome Measure Information:
Title
Clinical Severity Ratings
Time Frame
End of treatment and 12 months follow-up
Secondary Outcome Measure Information:
Title
Questionnaires: The Panic Attack Scale The Body Sensations Questionnaire The Agoraphobic Cognitions Questionnaire The Mobility Inventory for Agoraphobia Social Phobia Scale The Social Interaction Anxiety Scale
Time Frame
End of treatment and 12 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnoses of panic disorder or social phobia
Informed consent
Exclusion Criteria:
Alcohol/drug dependency
Major depressive disorder
Psychosis
Unstable medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
odd e havik, PhD
Organizational Affiliation
University of Bergen
Official's Role
Principal Investigator
Facility Information:
Facility Name
haukelandUH
City
Bergen
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
26708332
Citation
Haug T, Nordgreen T, Ost LG, Tangen T, Kvale G, Hovland OJ, Heiervang ER, Havik OE. Working alliance and competence as predictors of outcome in cognitive behavioral therapy for social anxiety and panic disorder in adults. Behav Res Ther. 2016 Feb;77:40-51. doi: 10.1016/j.brat.2015.12.004. Epub 2015 Dec 11.
Results Reference
derived
PubMed Identifier
26081010
Citation
Haug T, Nordgreen T, Ost LG, Kvale G, Tangen T, Andersson G, Carlbring P, Heiervang ER, Havik OE. Stepped care versus face-to-face cognitive behavior therapy for panic disorder and social anxiety disorder: Predictors and moderators of outcome. Behav Res Ther. 2015 Aug;71:76-89. doi: 10.1016/j.brat.2015.06.002. Epub 2015 Jun 9.
Results Reference
derived
Learn more about this trial
Treatment of Social Phobia and Panic Disorder in Adults
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