Generalized Anxiety DisorderNCT00426426
Comparing Cognitive Behaviour Therapy (CBT) With Metacognitive Therapy (MCT) in the Treatment of GAD
A study testing Cognitive-Behavioural Therapy, Meta-Cognitive Therapy and Waiting list in people with Generalized Anxiety Disorder, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Cognitive-Behavioural Therapy, Meta-Cognitive Therapy and Waiting list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2007to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed written informed consent obtained prior to entry in the study.
- Diagnosed with generalised anxiety disorder (DSM-IV, APA, 1994).
- 18 years or older.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Psychology, Norwegian University of Science and Technology
Trondheim, N-7491
About this study
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)
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.
Read more
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
- Being tested
- Cognitive-Behavioural Therapy, Meta-Cognitive Therapy, Waiting list
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioural TherapyBehavioural
12 sessions with Cognitive-Behavioural Therapy (CBT), and waiting list will be over 12 weeks, and then allocated into Meta-Cognitive Therapy.
Meta-Cognitive TherapyBehavioural
12 sessions with Meta-Cognitive Therapy (MCT), and waiting list will be over 12 weeks, and then allocated into Cognitive-Behavioural Therapy .
Waiting listBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Meta-Cognitive Therapy | Active comparator | first Meta-cognitive therapy then Cognitive Behaviour Therapy Receives: Behavioral: Cognitive-Behavioural Therapy; Behavioral: Meta-Cognitive Therapy; Behavioral: Waiting list |
| Cognitive Behaviour Therapy | Active comparator | first Cognitive Behaviour Therapy then Meta-cognitive therapy Receives: Behavioral: Cognitive-Behavioural Therapy; Behavioral: Meta-Cognitive Therapy; Behavioral: Waiting list |
| Waiting List | Other | Waiting List Receives: Behavioral: Waiting list |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSWQ by post treatment and by two year follow up.
Measured: March 2011
STAI-T
Measured: March 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University, University of Manchester
- Responsible party
- Sponsor
- Investigators
- Leif E Kennair, PhD, Principal investigator, Dept. of Psychology, NTNUHans M Nordahl, Ph.D, Study director, Department of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426426
- Sponsor's protocol ID
- 4.2006.2369
- Other IDs
- NSD: sak 15436
- Status last verified
- Oct 2018
- First submitted
- 23 Jan 2007
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28651207Nordahl 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.
PubMed 30294448
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00426426
- Acronym / sponsor ID
- 4.2006.2369
- Conditions
- Generalized Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Penn State University, University of Manchester
- Study start
- Jan 2007 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Meta-Cognitive Therapy | Active comparator | Behavioral: Cognitive-Behavioural Therapy, Behavioral: Meta-Cognitive Therapy, Behavioral: Waiting listfirst Meta-cognitive therapy then Cognitive Behaviour Therapy |
| Cognitive Behaviour Therapy | Active comparator | Behavioral: Cognitive-Behavioural Therapy, Behavioral: Meta-Cognitive Therapy, Behavioral: Waiting listfirst Cognitive Behaviour Therapy then Meta-cognitive therapy |
| Waiting List | Other | Behavioral: Waiting listWaiting List |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed written informed consent obtained prior to entry in the study.
- Diagnosed with generalised anxiety disorder (DSM-IV, APA, 1994).
- 18 years or older.
Key exclusion criteria (8 listed)
- Known somatic diseases
- Psychosis
- Past suicidal attempts and/or current intent
- PTSD
- Cluster A or cluster B personality disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-Behavioural Therapy12 sessions with Cognitive-Behavioural Therapy (CBT), and waiting list will be over 12 weeks, and then allocated into Meta-Cognitive Therapy. | Behavioural | Cognitive Behaviour Therapy, Meta-Cognitive Therapy |
| Meta-Cognitive Therapy12 sessions with Meta-Cognitive Therapy (MCT), and waiting list will be over 12 weeks, and then allocated into Cognitive-Behavioural Therapy . | Behavioural | Cognitive Behaviour Therapy, Meta-Cognitive Therapy |
| Waiting list | Behavioural | Cognitive Behaviour Therapy, Meta-Cognitive Therapy, Waiting List |
Primary outcome
PSWQ by post treatment and by two year follow up.
Time frame: March 2011
STAI-T
Time frame: March 2011
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Background: PubMed 28651207Johnson 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 publication: PubMed 30294448Nordahl 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leif E Kennair, PhD principal investigator
Dept. of Psychology, NTNU
Hans M Nordahl, Ph.D study director
Department of Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioural Therapy, Meta-Cognitive Therapy and Waiting list in people with Generalized Anxiety Disorder, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSWQ by post treatment and by two year follow up. (time frame: March 2011). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00426426, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.