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

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.

Study Overview

• Status: Completed
• Conditions: Mixed Anxiety Disorders
• Intervention / Treatment: Behavioral: Cognitive behavioral therapy; Behavioral: Metacognitive therapy

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Buskerud
    • Vikersund, Buskerud, Norway, 3370
      • Modum Bad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	PRE/POST/1 year follow up
Beck Anxiety Inventory (BAI)		PRE/POST/weekly and 1 year follow up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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 and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: June 26, 2013
• First Submitted That Met QC Criteria: June 27, 2013
• First Posted (Estimate): June 28, 2013

Study Record Updates

• Last Update Posted (Estimate): March 8, 2016
• Last Update Submitted That Met QC Criteria: March 7, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Anxiety disorders; Transdiagnostic; Metacognitive therapy; MCT
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Anxiety Disorders
• Other Study ID Numbers: SveJoh 1