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Mixed Anxiety DisordersNCT01889342

Metacognitive Therapy Versus Cognitive Behavioral Therapy for Mixed Anxiety Disorders: A Randomized Controlled Trial.

A study testing Metacognitive therapy and Cognitive behavioral therapy in people with Mixed Anxiety Disorders, run by Modum Bad at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Comorbidity is normal in clinical practice. Metacognitive Therapy (MCT) is a transdiagnostic model and could therefore be well suited when it comes to treating patients with high rates of comorbidity. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Mixed Anxiety Disorders
What is being tested?
Metacognitive therapy and Cognitive behavioral therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteNorway
Study dates
Aug 2013to 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

  • DSM IV diagnoses of SAD, PD/A or PTSD (CSR>4)
  • Withdraw of all psychotropic medications before treatment

Who cannot join

  • Psychosis
  • Not willing to accept randomization
  • Comorbid conditions are in immediate need of treatment

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Modum Bad

    Vikersund, Buskerud, 3370

Other trials in Norway

About this study

Comorbidity is normal in clinical practice. Metacognitive Therapy (MCT) is a transdiagnostic model and could therefore be well suited when it comes to treating patients with high rates of comorbidity. So far, no studies have examined MCT in comparison with the best documented and evidence based treatment, cognitive behavioral treatment(CBT), in a randomized controlled trial consisting of mixed anxiety disorder sample with high degree of comorbidity.

The main aim of this study is to 1) Evaluate the effectiveness of metacognitive therapy in a sample of mixed anxiety disorders as compared to a group receiving existing evidence-based single diagnosis CBT- treatment protocols 2) Investigate patterns and mechanisms of change in the two treatments.

Being tested
Metacognitive therapy, Cognitive behavioral therapy
Keywords
MCT, Metacognitive therapy, Anxiety disorders, Transdiagnostic
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01889342
Study groupRoleWhat they receive
Metacognitive therapyExperimentalThe treatment is based on the generic manual by Wells (2009).
Receives: Behavioral: Metacognitive therapy
Cognitive behavorial therapyActive comparatorCBT includes the diagnose specific manuals for panic disorder (Clark, 1986), Social Phobia (Clark \& Wells, 1995) and PTSD (Foa, 2007).
Receives: Behavioral: Cognitive behavioral therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anxiety Disorders Interview Schedule for DSM-IV-Lifetime Version

    The ADIS -IV is a semistructured diagnostic interview designed to establish reliable DSM-IV anxiety, mood, somatoform and substance disorders. Interviewers assign a 0-8 clinical severity rating (CSR), that indicate their judgement of the degree of distress.

    Measured: PRE/POST/1 year follow up

  2. Beck Anxiety Inventory (BAI)

    Measured: PRE/POST/weekly and 1 year follow up

Secondary outcomes (14)

  1. The Symptom Checklist 90(SCL90; Derogatis et al., 1996)

    Measured: Pre/Post/1 year follow up

  2. The Patient Health Questionnaire depression module (PHQ 9; Spitzer et al., 1999)

    Measured: Pre/Post and 1 year follow up

  3. Metacognitions Questionnaire- 30 (MCQ-30; Wells & Cartwright-Hatton, 2003)

    Measured: Pre/Post/weekly and 1 year follow up

  4. Working Alliance Inventory (WAI; Horwath & Greenberg, 1989)

    Measured: Pre/Post/weekly and 1 year follow up

  5. Cognitive attentional syndrome 1 (CAS1; Wells, 2009)

    Measured: Pre/Post/weekly and 1 year follow up

  6. The Repetitive Thinking Questionnaire(RTQ; McEvoy et al., 2010)

    Measured: Pre/Post and 1 year follow up

  7. PTSD Symptom scale Self Report (PSSR; Foa et al., 1993)

    Measured: Pre/Post and 1 year follow up

  8. Social Phobia Inventory (SPIN; Connor et al., 2000)

    Measured: Pre/Post and 1 year follow up

  9. Mobility inventory (MI; Chambless, 1985)

    Measured: Pre/Post and 1 year follow up

  10. SF 36

    Measured: Pre/Post and 1 year follow up

  11. The Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger & Borkovec, 1990)

    Measured: Pre/Post and 1 year follow up

  12. Youngs Schema Questionnaire YSQ -75 (Young, 1998)

    Measured: Pre/Post and 1 year follow up

  13. The Inventory of Interpersonal Problems (IIP 64 C; Horowitz et al., 1988)

    Measured: Pre/Post and 1 year follow up

  14. Dysfunctional emotion regulations scale (DERS; Graz & Roemer, 2004)

    Measured: Pre/Post/ and 1 year follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

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
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01889342
Sponsor's protocol ID
SveJoh 1
Status last verified
Mar 2016
First submitted
26 Jun 2013
Last updated
8 Mar 2016
Results posted
No
Data monitoring committee
No

Publications

  • Johnson SU, Hoffart A, Nordahl HM, Ulvenes PG, Vrabel K, Wampold BE. Metacognition and cognition in inpatient MCT and CBT for comorbid anxiety disorders: A study of within-person effects. J Couns Psychol. 2018 Jan;65(1):86-97. doi: 10.1037/cou0000226. Epub 2017 May 25.

    PubMed 28541060

Questions about this trial

What is this clinical trial studying?

A study testing Metacognitive therapy and Cognitive behavioral therapy in people with Mixed Anxiety Disorders, run by Modum Bad 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 2 inclusion and 3 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 8 Mar 2016. 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?

Anxiety Disorders Interview Schedule for DSM-IV-Lifetime Version (time frame: PRE/POST/1 year follow up). 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 NCT01889342, which also lists 1 linked publication.

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 8 Mar 2016.

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