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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Odd E Havik, Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT00619138
First received: January 16, 2008
Last updated: December 19, 2013
Last verified: December 2013
  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: 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 Haukeland University Hospital:

Primary Outcome Measures:
  • Clinical Severity Ratings [ Time Frame: End of treatment and 12 months follow-up ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: March 2008
Estimated 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619138

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

No publications provided

Responsible Party: Odd E Havik, professor, Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT00619138     History of Changes
Other Study ID Numbers: 17650
Study First Received: January 16, 2008
Last Updated: December 19, 2013
Health Authority: Norway: Norwegian Social Science Data Services

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

Additional relevant MeSH terms:
Panic Disorder
Phobic Disorders
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 20, 2014