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

Norwegian University of Science and Technology

Status: Completed

Conditions: Generalized Anxiety Disorder

Treatments: Behavioral: Cognitive-Behavioural Therapy; Behavioral: Meta-Cognitive Therapy; Behavioral: Waiting list

Study type: Interventional

Funder types: Other

Identifiers

NCT00426426

NSD: sak 15436 (Other Identifier)

4.2006.2369

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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68 participants in 3 patient groups

Meta-Cognitive Therapy

Active Comparator group

Description:

first Meta-cognitive therapy then Cognitive Behaviour Therapy

Treatment:

Behavioral: Meta-Cognitive Therapy

Behavioral: Waiting list

Behavioral: Cognitive-Behavioural Therapy

Cognitive Behaviour Therapy

Active Comparator group

Description:

first Cognitive Behaviour Therapy then Meta-cognitive therapy

Treatment:

Behavioral: Meta-Cognitive Therapy

Behavioral: Waiting list

Behavioral: Cognitive-Behavioural Therapy

Waiting List

Other group

Description:

Waiting List

Treatment:

Behavioral: Waiting list