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

Generalized Anxiety Disorder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00426426
• Other study ID #: 4.2006.2369
• Secondary ID: NSD: sak 15436
• Status: Completed
• Phase: N/A
• Start date: January 2007
• Est. completion date: December 2015

Study information

• Verified date: October 2018
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

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.
• 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 .
• Waiting list

Locations

Country	Name	City	State
Norway	Department of Psychology, Norwegian University of Science and Technology	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Penn State University, University of Manchester

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Johnson SU, Hoffart A, Nordahl HM, Wampold BE. Metacognitive therapy versus disorder-specific CBT for comorbid anxiety disorders: A randomized controlled trial. J Anxiety Disord. 2017 Aug;50:103-112. doi: 10.1016/j.janxdis.2017.06.004. Epub 2017 Jun 15. — View Citation

Nordahl HM, Borkovec TD, Hagen R, Kennair LEO, Hjemdal O, Solem S, Hansen B, Haseth S, Wells A. Metacognitive therapy versus cognitive-behavioural therapy in adults with generalised anxiety disorder. BJPsych Open. 2018 Sep 11;4(5):393-400. doi: 10.1192/bj — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSWQ by post treatment and by two year follow up.		March 2011
Primary	STAI-T		March 2011