Comparing Cognitive Behaviour Therapy (CBT) With Metacognitive Therapy (MCT) in the Treatment of GAD
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)
2 other identifiers
interventional
68
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 23, 2007
CompletedFirst Posted
Study publicly available on registry
January 24, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedOctober 11, 2018
October 1, 2018
7.9 years
January 23, 2007
October 9, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
PSWQ by post treatment and by two year follow up.
March 2011
STAI-T
March 2011
Study Arms (3)
Meta-Cognitive Therapy
ACTIVE COMPARATORfirst Meta-cognitive therapy then Cognitive Behaviour Therapy
Cognitive Behaviour Therapy
ACTIVE COMPARATORfirst Cognitive Behaviour Therapy then Meta-cognitive therapy
Waiting List
OTHERWaiting List
Interventions
12 sessions with Cognitive-Behavioural Therapy (CBT), and waiting list will be over 12 weeks, and then allocated into 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 .
Eligibility Criteria
You may qualify if:
- Signed written informed consent obtained prior to entry in the study.
- Diagnosed with generalised anxiety disorder (DSM-IV, APA, 1994).
- years or older.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian University of Science and Technologylead
- Penn State Universitycollaborator
- University of Manchestercollaborator
Study Sites (1)
Department of Psychology, Norwegian University of Science and Technology
Trondheim, N-7491, Norway
Related Publications (2)
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.
PMID: 28651207BACKGROUNDNordahl 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.
PMID: 30294448RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leif E Kennair, PhD
Dept. of Psychology, NTNU
- STUDY DIRECTOR
Hans M Nordahl, Ph.D
Department of Psychology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2007
First Posted
January 24, 2007
Study Start
January 1, 2007
Primary Completion
December 1, 2014
Study Completion
December 1, 2015
Last Updated
October 11, 2018
Record last verified: 2018-10