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Clinical Trials/NCT00426426
NCT00426426CompletedNot Applicable

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)

Norwegian University of Science and Technology2 sites in 1 country68 target enrollmentStarted: January 2007Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
68
Locations
2
Primary Endpoint
STAI-T

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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
  • Past suicidal attempts and/or current intent
  • 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

Arms & Interventions

Meta-Cognitive Therapy

Active Comparator

first Meta-cognitive therapy then Cognitive Behaviour Therapy

Intervention: Cognitive-Behavioural Therapy (Behavioral)

Meta-Cognitive Therapy

Active Comparator

first Meta-cognitive therapy then Cognitive Behaviour Therapy

Intervention: Meta-Cognitive Therapy (Behavioral)

Meta-Cognitive Therapy

Active Comparator

first Meta-cognitive therapy then Cognitive Behaviour Therapy

Intervention: Waiting list (Behavioral)

Cognitive Behaviour Therapy

Active Comparator

first Cognitive Behaviour Therapy then Meta-cognitive therapy

Intervention: Cognitive-Behavioural Therapy (Behavioral)

Cognitive Behaviour Therapy

Active Comparator

first Cognitive Behaviour Therapy then Meta-cognitive therapy

Intervention: Meta-Cognitive Therapy (Behavioral)

Cognitive Behaviour Therapy

Active Comparator

first Cognitive Behaviour Therapy then Meta-cognitive therapy

Intervention: Waiting list (Behavioral)

Waiting List

Other

Waiting List

Intervention: Waiting list (Behavioral)

Outcomes

Primary Outcomes

STAI-T

Time Frame: March 2011

PSWQ by post treatment and by two year follow up.

Time Frame: March 2011

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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