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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
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 16, 2008
Last Updated
January 25, 2016
Sponsor
Haukeland University Hospital
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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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