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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Behavioral: Cognitive-Behavioural Therapy
* Behavioral: Meta-Cognitive Therapy
* Behavioral: Waiting list


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed written informed consent obtained prior to entry in the study. Diagnosed with generalised anxiety disorder (DSM-IV, APA, 1994). 18 years or older. Exclusion Criteria: Known somatic diseases Psychosis Past suicidal attempts and/or current intent PTSD Cluster A or cluster B personality disorder Substance dependence Not willing to accept random allocation. Patients not willing to withdraw psychotropic medication for a period of 4 weeks prior to entry to the trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Meta-Cognitive Therapy<br>first Meta-cognitive therapy then Cognitive Behaviour Therapy | Behavioral: Cognitive-Behavioural Therapy<br>* 12 sessions with Cognitive-Behavioural Therapy (CBT), and waiting list will be over 12 weeks, and then allocated into Meta-Cognitive Therapy.<br>Behavioral: Meta-Cognitive Therapy<br>* 12 sessions with Meta-Cognitive Therapy (MCT), and waiting list will be over 12 weeks, and then allocated into Cognitive-Behavioural Therapy .<br>Behavioral: Waiting list<br> <br> |
| Active Comparator: Cognitive Behaviour Therapy<br>first Cognitive Behaviour Therapy then Meta-cognitive therapy | Behavioral: Cognitive-Behavioural Therapy<br>* 12 sessions with Cognitive-Behavioural Therapy (CBT), and waiting list will be over 12 weeks, and then allocated into Meta-Cognitive Therapy.<br>Behavioral: Meta-Cognitive Therapy<br>* 12 sessions with Meta-Cognitive Therapy (MCT), and waiting list will be over 12 weeks, and then allocated into Cognitive-Behavioural Therapy .<br>Behavioral: Waiting list<br> <br> |
| Other: Waiting List<br>Waiting List | Behavioral: Waiting list<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSWQ by post treatment and by two year follow up. |  | March 2011 | 
| STAI-T |  | March 2011 |