Clinical trial NCT00426426: Comparing Cognitive Behaviour Therapy (CBT) With Metacognitive Therapy (MCT) in the Treatment of GAD
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Penn State University
name: University of Manchester
First posted: 2007-01-24
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: PSWQ by post treatment and by two year follow up.
timeFrame: March 2011
measure: STAI-T
timeFrame: March 2011
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Psychology, Norwegian University of Science and Technology
Study officials:
affiliation: Dept. of Psychology, NTNU
name: Leif E Kennair, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychology
name: Hans M Nordahl, Ph.D
role: STUDY_DIRECTOR
References:
citation: 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.
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/bjo.2018.54. eCollection 2018 Sep.