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

Not Applicable

Completed

• Conditions: Generalized Anxiety Disorder
• Interventions: Behavioral: Cognitive-Behavioural Therapy; Behavioral: Meta-Cognitive Therapy; Behavioral: Waiting list

• Registration Number: NCT00426426
• Lead Sponsor: Norwegian University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-23
• Study First Submitted QC: 2007-01-23
• Study First Posted: 2007-01-24
• Primary Completion: 2014-12
• Study Completion: 2015-12
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-09
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Cognitive Behaviour Therapy	Waiting list	first Cognitive Behaviour Therapy then Meta-cognitive therapy
Meta-Cognitive Therapy	Waiting list	first Meta-cognitive therapy then Cognitive Behaviour Therapy
Cognitive Behaviour Therapy	Cognitive-Behavioural Therapy	first Cognitive Behaviour Therapy then Meta-cognitive therapy
Cognitive Behaviour Therapy	Meta-Cognitive Therapy	first Cognitive Behaviour Therapy then Meta-cognitive therapy
Waiting List	Waiting list	Waiting List
Meta-Cognitive Therapy	Cognitive-Behavioural Therapy	first Meta-cognitive therapy then Cognitive Behaviour Therapy
Meta-Cognitive Therapy	Meta-Cognitive Therapy	first Meta-cognitive therapy then Cognitive Behaviour Therapy

Primary Outcome Measures

Name	Time	Method
STAI-T	March 2011
PSWQ by post treatment and by two year follow up.	March 2011

Trial Locations

Locations (1)

Department of Psychology, Norwegian University of Science and Technology; 🇳🇴 Trondheim, Norway