We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Social Phobia and Panic Disorder in Adults (TSPPA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00619138
First Posted: February 20, 2008
Last Update Posted: January 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Odd E Havik, Haukeland University Hospital
  Purpose
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.

Condition Intervention Phase
Social Phobia Panic Disorder Behavioral: individual cognitive-behavioural therapy Behavioral: stepped care model Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Study of a Stepped-care Model for the Treatment of Social Phobia and Panic Disorder in Adults

Resource links provided by NLM:


Further study details as provided by Odd E Havik, Haukeland University Hospital:

Primary Outcome Measures:
  • Clinical Severity Ratings [ Time Frame: End of treatment and 12 months follow-up ]

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 [ Time Frame: End of treatment and 12 months follow-up ]

Enrollment: 174
Study Start Date: March 2008
Study Completion Date: December 2015
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Behavioral: individual cognitive-behavioural therapy
1 session per week for 12 weeks
Active Comparator: 2 Behavioral: stepped care model
three steps: short psycho-education, a 10 weeks Internet-based self-help program, 12 weeks individual cognitive-behavioural therapy

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnoses of panic disorder or social phobia
  • Informed consent

Exclusion Criteria:

  • Alcohol/drug dependency
  • Major depressive disorder
  • Psychosis
  • Unstable medication
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00619138


Locations
Norway
haukelandUH
Bergen, Norway
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Principal Investigator: odd e havik, PhD University of Bergen
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Odd E Havik, professor, Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT00619138     History of Changes
Other Study ID Numbers: 17650
First Submitted: January 16, 2008
First Posted: February 20, 2008
Last Update Posted: January 26, 2016
Last Verified: January 2016

Keywords provided by Odd E Havik, Haukeland University Hospital:
Cognitive therapy
Stepped care
Self-help
Internet
Anxiety

Additional relevant MeSH terms:
Disease
Panic Disorder
Phobic Disorders
Phobia, Social
Pathologic Processes
Anxiety Disorders
Mental Disorders