Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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 3, 2016
Last verified: August 2016

January 23, 2007
August 3, 2016
January 2007
March 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • Fulfilled criteria on the ADIS-IV
  • PSWQ by post treatment and by two year follow up.
Complete list of historical versions of study NCT00426426 on ClinicalTrials.gov Archive Site
Not Provided
  • GADs
  • Relapse rates during the follow up
  • Psychophysiological measures
Not Provided
Not Provided
 
Comparing Cognitive Behaviour Therapy (CBT) With Metacognitive Therapy (MCT) in the Treatment of GAD
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)

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Generalized Anxiety Disorder
  • Behavioral: Cognitive-Behavioural Therapy
    12 sessions with Cognitive-Behavioural Therapy (CBT), and waiting list will be over 12 weeks, and then allocated into Meta-Cognitive Therapy.
  • Behavioral: Meta-Cognitive Therapy
    12 sessions with Meta-Cognitive Therapy (MCT), and waiting list will be over 12 weeks, and then allocated into Cognitive-Behavioural Therapy .
  • Behavioral: Waiting list
  • Active Comparator: Meta-Cognitive Therapy
    first Meta-cognitive therapy then Cognitive Behaviour Therapy
    Interventions:
    • Behavioral: Cognitive-Behavioural Therapy
    • Behavioral: Meta-Cognitive Therapy
    • Behavioral: Waiting list
  • Active Comparator: Cognitive Behaviour Therapy
    first Cognitive Behaviour Therapy then Meta-cognitive therapy
    Interventions:
    • Behavioral: Cognitive-Behavioural Therapy
    • Behavioral: Meta-Cognitive Therapy
    • Behavioral: Waiting list
  • Waiting List
    Waiting List
    Intervention: Behavioral: Waiting list
Ingul JM, Aune T, Nordahl HM. A randomized controlled trial of individual cognitive therapy, group cognitive behaviour therapy and attentional placebo for adolescent social phobia. Psychother Psychosom. 2014;83(1):54-61. doi: 10.1159/000354672.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
March 2011
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00426426
4.2006.2369, NSD: sak 15436
No
Not Provided
Not Provided
Norwegian University of Science and Technology
Norwegian University of Science and Technology
  • Penn State University
  • University of Manchester
Principal Investigator: Leif E Kennair, PhD Dept. of Psychology, NTNU
Study Director: Hans M Nordahl, Ph.D Department of Psychology
Norwegian University of Science and Technology
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP