Treatment of Social Phobia and Panic Disorder in Adults

Panic Disorder Clinical Trial

— TSPPA  

Official title:

A Randomized, Controlled Study of a Stepped-care Model for the Treatment of Social Phobia and Panic Disorder in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00619138
• Other study ID #: 17650
• Status: Completed
• Phase: Phase 3
• First received: January 16, 2008
• Last updated: January 25, 2016
• Start date: March 2008
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: December 2015
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinical diagnoses of panic disorder or social phobia

• Informed consent

Exclusion Criteria:

• Alcohol/drug dependency

• Major depressive disorder

• Psychosis

• Unstable medication

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Panic Disorder
• Phobic Disorders
• Social Phobia

Intervention

Behavioral:
• individual cognitive-behavioural therapy
1 session per week for 12 weeks
• stepped care model
three steps: short psycho-education, a 10 weeks Internet-based self-help program, 12 weeks individual cognitive-behavioural therapy

Locations

Country	Name	City	State
Norway	haukelandUH	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Severity Ratings		End of treatment and 12 months follow-up	No
Secondary	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		End of treatment and 12 months follow-up	No