NCT00619138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2008

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 20, 2008

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

4.2 years

First QC Date

January 16, 2008

Last Update Submit

January 25, 2016

Conditions

Keywords

Cognitive therapyStepped careSelf-helpInternetAnxiety

Outcome Measures

Primary Outcomes (1)

  • Clinical Severity Ratings

    End of treatment and 12 months follow-up

Secondary Outcomes (1)

  • 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

Study Arms (2)

1

ACTIVE COMPARATOR
Behavioral: individual cognitive-behavioural therapy

2

ACTIVE COMPARATOR
Behavioral: stepped care model

Interventions

1 session per week for 12 weeks

1

three steps: short psycho-education, a 10 weeks Internet-based self-help program, 12 weeks individual cognitive-behavioural therapy

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Alcohol/drug dependency
  • Major depressive disorder
  • Psychosis
  • Unstable medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

haukelandUH

Bergen, Norway

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Phobia, SocialPanic DisorderAnxiety Disorders

Condition Hierarchy (Ancestors)

Phobic DisordersMental Disorders

Study Officials

  • odd e havik, PhD

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 16, 2008

First Posted

February 20, 2008

Study Start

March 1, 2008

Primary Completion

May 1, 2012

Study Completion

December 1, 2015

Last Updated

January 26, 2016

Record last verified: 2016-01

Locations