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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Modum Bad
Sponsor:
Information provided by (Responsible Party):
Modum Bad
ClinicalTrials.gov Identifier:
NCT01889342
First received: June 26, 2013
Last updated: December 3, 2013
Last verified: May 2013
  Purpose

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 Intervention
Mixed Anxiety Disorders
Behavioral: Metacognitive therapy
Behavioral: Cognitive behavioral therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metacognitive Therapy Versus Cognitive Behavioral Therapy for Mixed Anxiety Disorders: A Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Modum Bad:

Primary Outcome Measures:
  • Anxiety Disorders Interview Schedule for DSM-IV-Lifetime Version [ Time Frame: PRE/POST/1 year follow up ] [ Designated as safety issue: No ]
    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.

  • Beck Anxiety Inventory (BAI) [ Time Frame: PRE/POST/weekly and 1 year follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Symptom Checklist 90(SCL90; Derogatis et al., 1996) [ Time Frame: Pre/Post/1 year follow up ] [ Designated as safety issue: No ]
  • The Patient Health Questionnaire depression module (PHQ 9; Spitzer et al., 1999) [ Time Frame: Pre/Post and 1 year follow up ] [ Designated as safety issue: No ]
  • Metacognitions Questionnaire- 30 (MCQ-30; Wells & Cartwright-Hatton, 2003) [ Time Frame: Pre/Post/weekly and 1 year follow up ] [ Designated as safety issue: No ]
  • Working Alliance Inventory (WAI; Horwath & Greenberg, 1989) [ Time Frame: Pre/Post/weekly and 1 year follow up ] [ Designated as safety issue: No ]
  • Cognitive attentional syndrome 1 (CAS1; Wells, 2009) [ Time Frame: Pre/Post/weekly and 1 year follow up ] [ Designated as safety issue: No ]
  • The Repetitive Thinking Questionnaire(RTQ; McEvoy et al., 2010) [ Time Frame: Pre/Post and 1 year follow up ] [ Designated as safety issue: No ]
  • PTSD Symptom scale Self Report (PSSR; Foa et al., 1993) [ Time Frame: Pre/Post and 1 year follow up ] [ Designated as safety issue: No ]
  • Social Phobia Inventory (SPIN; Connor et al., 2000) [ Time Frame: Pre/Post and 1 year follow up ] [ Designated as safety issue: No ]
  • Mobility inventory (MI; Chambless, 1985) [ Time Frame: Pre/Post and 1 year follow up ] [ Designated as safety issue: No ]
  • SF 36 [ Time Frame: Pre/Post and 1 year follow up ] [ Designated as safety issue: No ]
  • The Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger & Borkovec, 1990) [ Time Frame: Pre/Post and 1 year follow up ] [ Designated as safety issue: No ]
  • Youngs Schema Questionnaire YSQ -75 (Young, 1998) [ Time Frame: Pre/Post and 1 year follow up ] [ Designated as safety issue: No ]
  • The Inventory of Interpersonal Problems (IIP 64 C; Horowitz et al., 1988) [ Time Frame: Pre/Post and 1 year follow up ] [ Designated as safety issue: No ]
  • Dysfunctional emotion regulations scale (DERS; Graz & Roemer, 2004) [ Time Frame: Pre/Post/ and 1 year follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01889342

Contacts
Contact: Asle Hoffart, Ph.D +4732749700 asle.hoffart@modum-bad.no
Contact: Sverre Urnes Johnson, MA Sverre.Johnson@modum-bad.no

Locations
Norway
Modum Bad Recruiting
Vikersund, Buskerud, Norway, 3370
Principal Investigator: Sverre Urnes Johnson, MA         
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
  More Information

No publications provided

Responsible Party: Modum Bad
ClinicalTrials.gov Identifier: NCT01889342     History of Changes
Other Study ID Numbers: SveJoh 1
Study First Received: June 26, 2013
Last Updated: December 3, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014