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| Sponsored by: |
Norwegian University of Science and Technology |
|---|---|
| Information provided by: | Norwegian University of Science and Technology |
| ClinicalTrials.gov Identifier: | NCT00426426 |
Purpose
Meta Cognitive Therapy (MCT) has been introduced as a new specific treatment for generalised anxiety disorder. So far, no studies have examined CBT and MCT in comparison with each other in a randomised controlled trial. Sixty patients with a diagnosis of generalised anxiety disorder will be selected and randomised into three treatment conditions. The first group (N=20) will be treated with CBT, the second group (N=20) with MCT, and the third condition is a waiting list control (N=20). The patients in both groups will have full treatment, in accordance to treatment manuals developed by the originators. Patients in the waiting list control will be randomly allocated to either CBT or MCT after 12 weeks of waiting period.
The patients will be assessed with the primary measures at pre-treatment, at the end of treatment, and at follow-up after one and two years. In addition they will be assessed weekly on symptom measures and worry outcome diary. The therapist will be treating equally amount of patients in both conditions to control for any biased distribution connected to the therapist's characteristics.
Measures will be used on at least three main sources; self-report inventories (including symptom diaries), clinical assessments by independent raters and psycho-physiological assessments.
We aim to (1) evaluate and compare the effectiveness of CBT and MCT, (2) investigate the patterns of change and the mechanisms of action involved during treatment in each of the conditions and, (3) evaluate pre and post-treatment somatic change by psycho-physiological assessments as a response to CBT and MCT.
| Condition | Intervention | Phase |
|---|---|---|
|
Generalized Anxiety Disorder |
Behavioral: Cognitive-behavioural Therapy, Meta-Cognitive Therapy |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomised Controlled Trial Comparing the Effectiveness of Cognitive Behaviour Therapy (CBT) With Metacognitive Therapy (MCT) in the Treatment of Patients With Generalised Anxiety Disorder (GAD) |
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Hans M Nordahl, PhD | 73595000 ext 58292 | hans.nordahl@svt.ntnu.no |
| Norway | |
| Department of Psychology, Norwegian University of Science and Technology | Recruiting |
| Trondheim, Norway, N-7491 | |
| Contact: Hans M Nordahl, Ph.D 73 59 50 00 ext 59282 hans.nordahl@svt.ntnu.no | |
| Principal Investigator: | Leif E Kennair, PhD | Dept. of Psychology, NTNU |
| Study Director: | Hans M Nordahl, Ph.D | Department of Psychology |
More Information
| Responsible Party: | Norwegian University of Science and Technology ( Kennair, Leif Edward Ottesen, associate professor ) |
| Study ID Numbers: | 4.2006.2369, NSD: sak 15436 |
| Study First Received: | January 23, 2007 |
| Last Updated: | February 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00426426 History of Changes |
| Health Authority: | Norway: Norwegian Social Science Data Services |
|
Anxiety Disorders Mental Disorders |
|
Pathologic Processes Disease Anxiety Disorders Mental Disorders |
