Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Comparing Cognitive Behaviour Therapy (CBT) With Metacognitive Therapy (MCT) in the Treatment of GAD
This study is currently recruiting participants.
Verified by Norwegian University of Science and Technology, January 2007
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

MedlinePlus related topics: Anxiety
U.S. FDA Resources
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)

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Fulfilled criteria on the ADIS-IV
  • PSWQ by post treatment and by two year follow up.

Secondary Outcome Measures:
  • GADs
  • Relapse rates during the follow up
  • Psychophysiological measures

Estimated Enrollment: 60
Study Start Date: January 2007
Estimated Study Completion Date: December 2010
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Signed written informed consent obtained prior to entry in the study.
  2. Diagnosed with generalised anxiety disorder (DSM-IV, APA, 1994).
  3. 18 years or older.

Exclusion Criteria:

  1. Known somatic diseases
  2. Psychosis
  3. Past suicidal attempts and/or current intent
  4. PTSD
  5. Cluster A or cluster B personality disorder
  6. Substance dependence
  7. Not willing to accept random allocation.
  8. Patients not willing to withdraw psychotropic medication for a period of 4 weeks prior to entry to the trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00426426

Contacts
Contact: Hans M Nordahl, PhD 73595000 ext 58292 hans.nordahl@svt.ntnu.no

Locations
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    
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Principal Investigator: Leif E Kennair, PhD Dept. of Psychology, NTNU
Study Director: Hans M Nordahl, Ph.D Department of Psychology
  More Information

Study ID Numbers: 4.2006.2369, NSD: sak 15436
Study First Received: January 23, 2007
Last Updated: January 23, 2007
ClinicalTrials.gov Identifier: NCT00426426  
Health Authority: Norway: Norwegian Social Science Data Services

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 13, 2009