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

NCT ID: NCT00426426

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2015-12-31

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.

Conditions

Generalized Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Meta-Cognitive Therapy

first Meta-cognitive therapy then Cognitive Behaviour Therapy

Group Type: ACTIVE_COMPARATOR

Cognitive-Behavioural Therapy

Intervention Type: BEHAVIORAL

12 sessions with Cognitive-Behavioural Therapy (CBT), and waiting list will be over 12 weeks, and then allocated into Meta-Cognitive Therapy.

Meta-Cognitive Therapy

Intervention Type: BEHAVIORAL

12 sessions with Meta-Cognitive Therapy (MCT), and waiting list will be over 12 weeks, and then allocated into Cognitive-Behavioural Therapy .

Waiting list

Intervention Type: BEHAVIORAL

Cognitive Behaviour Therapy

first Cognitive Behaviour Therapy then Meta-cognitive therapy

Group Type: ACTIVE_COMPARATOR

Cognitive-Behavioural Therapy

Intervention Type: BEHAVIORAL

12 sessions with Cognitive-Behavioural Therapy (CBT), and waiting list will be over 12 weeks, and then allocated into Meta-Cognitive Therapy.

Meta-Cognitive Therapy

Intervention Type: BEHAVIORAL

12 sessions with Meta-Cognitive Therapy (MCT), and waiting list will be over 12 weeks, and then allocated into Cognitive-Behavioural Therapy .

Waiting list

Intervention Type: BEHAVIORAL

Waiting List

Waiting List

Group Type: OTHER

Waiting list

Intervention Type: BEHAVIORAL

Interventions

Cognitive-Behavioural Therapy

12 sessions with Cognitive-Behavioural Therapy (CBT), and waiting list will be over 12 weeks, and then allocated into Meta-Cognitive Therapy.

Intervention Type: BEHAVIORAL

Meta-Cognitive Therapy

12 sessions with Meta-Cognitive Therapy (MCT), and waiting list will be over 12 weeks, and then allocated into Cognitive-Behavioural Therapy .

Intervention Type: BEHAVIORAL

Waiting list

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Penn State University

OTHER

Sponsor Role: collaborator

University of Manchester

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leif E Kennair, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Psychology, NTNU

Hans M Nordahl, Ph.D

Role: STUDY_DIRECTOR

Department of Psychology

Locations

Department of Psychology, Norwegian University of Science and Technology

Trondheim, , Norway

Countries

Norway

References

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.

Reference Type: BACKGROUND

PMID: 28651207 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30294448 (View on PubMed)

Other Identifiers

NSD: sak 15436

Identifier Type: OTHER

Identifier Source: secondary_id

4.2006.2369

Identifier Type: -

Identifier Source: org_study_id