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

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ClinicalTrials.gov Identifier: NCT01889342
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : March 8, 2016
Sponsor:
Information provided by (Responsible Party):
Modum Bad

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Mixed Anxiety Disorders Behavioral: Metacognitive therapy Behavioral: Cognitive behavioral therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metacognitive Therapy Versus Cognitive Behavioral Therapy for Mixed Anxiety Disorders: A Randomized Controlled Trial.
Study Start Date : August 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Metacognitive therapy
The treatment is based on the generic manual by Wells (2009).
Behavioral: Metacognitive therapy
Active Comparator: Cognitive behavorial therapy
CBT includes the diagnose specific manuals for panic disorder (Clark, 1986), Social Phobia (Clark & Wells, 1995) and PTSD (Foa, 2007).
Behavioral: Cognitive behavioral therapy



Primary Outcome Measures :
  1. Anxiety Disorders Interview Schedule for DSM-IV-Lifetime Version [ Time Frame: PRE/POST/1 year follow up ]
    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.

  2. Beck Anxiety Inventory (BAI) [ Time Frame: PRE/POST/weekly and 1 year follow up ]

Secondary Outcome Measures :
  1. The Symptom Checklist 90(SCL90; Derogatis et al., 1996) [ Time Frame: Pre/Post/1 year follow up ]
  2. The Patient Health Questionnaire depression module (PHQ 9; Spitzer et al., 1999) [ Time Frame: Pre/Post and 1 year follow up ]
  3. Metacognitions Questionnaire- 30 (MCQ-30; Wells & Cartwright-Hatton, 2003) [ Time Frame: Pre/Post/weekly and 1 year follow up ]
  4. Working Alliance Inventory (WAI; Horwath & Greenberg, 1989) [ Time Frame: Pre/Post/weekly and 1 year follow up ]
  5. Cognitive attentional syndrome 1 (CAS1; Wells, 2009) [ Time Frame: Pre/Post/weekly and 1 year follow up ]
  6. The Repetitive Thinking Questionnaire(RTQ; McEvoy et al., 2010) [ Time Frame: Pre/Post and 1 year follow up ]
  7. PTSD Symptom scale Self Report (PSSR; Foa et al., 1993) [ Time Frame: Pre/Post and 1 year follow up ]
  8. Social Phobia Inventory (SPIN; Connor et al., 2000) [ Time Frame: Pre/Post and 1 year follow up ]
  9. Mobility inventory (MI; Chambless, 1985) [ Time Frame: Pre/Post and 1 year follow up ]
  10. SF 36 [ Time Frame: Pre/Post and 1 year follow up ]
  11. The Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger & Borkovec, 1990) [ Time Frame: Pre/Post and 1 year follow up ]
  12. Youngs Schema Questionnaire YSQ -75 (Young, 1998) [ Time Frame: Pre/Post and 1 year follow up ]
  13. The Inventory of Interpersonal Problems (IIP 64 C; Horowitz et al., 1988) [ Time Frame: Pre/Post and 1 year follow up ]
  14. Dysfunctional emotion regulations scale (DERS; Graz & Roemer, 2004) [ Time Frame: Pre/Post/ and 1 year follow up ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889342


Locations
Norway
Modum Bad
Vikersund, Buskerud, Norway, 3370
Sponsors and Collaborators
Modum Bad
Investigators
Study Chair: Asle Hoffart, Ph.D Modum Bad and University of Oslo
Principal Investigator: Sverre Urnes Johnson, MA Modum Bad and University of Oslo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Modum Bad
ClinicalTrials.gov Identifier: NCT01889342     History of Changes
Other Study ID Numbers: SveJoh 1
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: March 2016

Keywords provided by Modum Bad:
MCT
Metacognitive therapy
Anxiety disorders
Transdiagnostic

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders