Metacognitive Therapy Versus Cognitive Behavioral Therapy for Mixed Anxiety Disorders: A Randomized Controlled Trial.
|ClinicalTrials.gov Identifier: NCT01889342|
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : March 8, 2016
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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|
- 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.
- Beck Anxiety Inventory (BAI) [ Time Frame: PRE/POST/weekly and 1 year follow up ]
- The Symptom Checklist 90(SCL90; Derogatis et al., 1996) [ Time Frame: Pre/Post/1 year follow up ]
- The Patient Health Questionnaire depression module (PHQ 9; Spitzer et al., 1999) [ Time Frame: Pre/Post and 1 year follow up ]
- Metacognitions Questionnaire- 30 (MCQ-30; Wells & Cartwright-Hatton, 2003) [ Time Frame: Pre/Post/weekly and 1 year follow up ]
- Working Alliance Inventory (WAI; Horwath & Greenberg, 1989) [ Time Frame: Pre/Post/weekly and 1 year follow up ]
- Cognitive attentional syndrome 1 (CAS1; Wells, 2009) [ Time Frame: Pre/Post/weekly and 1 year follow up ]
- The Repetitive Thinking Questionnaire(RTQ; McEvoy et al., 2010) [ Time Frame: Pre/Post and 1 year follow up ]
- PTSD Symptom scale Self Report (PSSR; Foa et al., 1993) [ Time Frame: Pre/Post and 1 year follow up ]
- Social Phobia Inventory (SPIN; Connor et al., 2000) [ Time Frame: Pre/Post and 1 year follow up ]
- Mobility inventory (MI; Chambless, 1985) [ Time Frame: Pre/Post and 1 year follow up ]
- SF 36 [ Time Frame: Pre/Post and 1 year follow up ]
- The Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger & Borkovec, 1990) [ Time Frame: Pre/Post and 1 year follow up ]
- Youngs Schema Questionnaire YSQ -75 (Young, 1998) [ Time Frame: Pre/Post and 1 year follow up ]
- The Inventory of Interpersonal Problems (IIP 64 C; Horowitz et al., 1988) [ Time Frame: Pre/Post and 1 year follow up ]
- Dysfunctional emotion regulations scale (DERS; Graz & Roemer, 2004) [ Time Frame: Pre/Post/ and 1 year follow up ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889342
|Vikersund, Buskerud, Norway, 3370|
|Study Chair:||Asle Hoffart, Ph.D||Modum Bad and University of Oslo|
|Principal Investigator:||Sverre Urnes Johnson, MA||Modum Bad and University of Oslo|