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Comparing Cognitive Behaviour Therapy (CBT) With Metacognitive Therapy (MCT) in the Treatment of GAD

This study has been completed.
Sponsor:
Collaborators:
Penn State University
University of Manchester
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00426426
First received: January 23, 2007
Last updated: August 23, 2011
Last verified: August 2011
History of Changes
  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; Waiting list
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

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

Primary Outcome Measures:
  • PSWQ by post treatment and by two year follow up. [ Time Frame: March 2011 ] [ Designated as safety issue: No ]
  • STAI-T [ Time Frame: March 2011 ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: January 2007
Study Completion Date: March 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metacognitive therapy
Metacognitive therapy
 Behavioral: Cognitive-behavioural Therapy, Meta-Cognitive Therapy; Waiting list
12 sessions with CBT or MCT, and waiting list will be over 12 weeks, and then allocated into one of the treatment arms.
Active Comparator: Cognitive Behaviour Therapy
CBT
 Behavioral: Cognitive-behavioural Therapy, Meta-Cognitive Therapy; Waiting list
12 sessions with CBT or MCT, and waiting list will be over 12 weeks, and then allocated into one of the treatment arms.
No Intervention: Waiting List
Waiting List
 Behavioral: Cognitive-behavioural Therapy, Meta-Cognitive Therapy; Waiting list
12 sessions with CBT or MCT, and waiting list will be over 12 weeks, and then allocated into one of the treatment arms.

  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

Locations
Norway
Department of Psychology, Norwegian University of Science and Technology
Trondheim, Norway, N-7491
Sponsors and Collaborators
Norwegian University of Science and Technology
Penn State University
University of Manchester
Investigators
Principal Investigator: Leif E Kennair, PhD Dept. of Psychology, NTNU
Study Director: Hans M Nordahl, Ph.D Department of Psychology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00426426     History of Changes
Other Study ID Numbers: 4.2006.2369, NSD: sak 15436
Study First Received: January 23, 2007
Last Updated: August 23, 2011
Health Authority: Norway: Norwegian Social Science Data Services

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013