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

Study Overview
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Brief Summary
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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.

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

Conditions
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Mixed Anxiety Disorders

Intervention / Treatment
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* Behavioral: Metacognitive therapy
* Behavioral: Cognitive behavioral therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MCT, Metacognitive therapy, Anxiety disorders, Transdiagnostic