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

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Cognitive-Behavioural Therapy
Meta-Cognitive Therapy
Waiting list
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Department of Psychology, Norwegian University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

Meta-Cognitive Therapy

Cognitive Behaviour Therapy

Waiting List

Arm Description

first Meta-cognitive therapy then Cognitive Behaviour Therapy

first Cognitive Behaviour Therapy then Meta-cognitive therapy

Waiting List

Outcomes

Primary Outcome Measures

PSWQ by post treatment and by two year follow up.
STAI-T

Secondary Outcome Measures

Full Information

First Posted
January 23, 2007
Last Updated
October 9, 2018
Sponsor
Norwegian University of Science and Technology
Collaborators
Penn State University, University of Manchester
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1. Study Identification

Unique Protocol Identification Number
NCT00426426
Brief Title
Comparing Cognitive Behaviour Therapy (CBT) With Metacognitive Therapy (MCT) in the Treatment of GAD
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 2007 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Penn State University, University of Manchester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meta-Cognitive Therapy
Arm Type
Active Comparator
Arm Description
first Meta-cognitive therapy then Cognitive Behaviour Therapy
Arm Title
Cognitive Behaviour Therapy
Arm Type
Active Comparator
Arm Description
first Cognitive Behaviour Therapy then Meta-cognitive therapy
Arm Title
Waiting List
Arm Type
Other
Arm Description
Waiting List
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioural Therapy
Intervention Description
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
Intervention Name(s)
Meta-Cognitive Therapy
Intervention Description
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
Intervention Name(s)
Waiting list
Primary Outcome Measure Information:
Title
PSWQ by post treatment and by two year follow up.
Time Frame
March 2011
Title
STAI-T
Time Frame
March 2011

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leif E Kennair, PhD
Organizational Affiliation
Dept. of Psychology, NTNU
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hans M Nordahl, Ph.D
Organizational Affiliation
Department of Psychology
Official's Role
Study Director
Facility Information:
Facility Name
Department of Psychology, Norwegian University of Science and Technology
City
Trondheim
ZIP/Postal Code
N-7491
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
28651207
Citation
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.
Results Reference
background
PubMed Identifier
30294448
Citation
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.
Results Reference
result

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

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