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

Not Applicable

Completed

• Conditions: Mixed Anxiety Disorders
• Interventions: Behavioral: Metacognitive therapy; Behavioral: Cognitive behavioral therapy

• Registration Number: NCT01889342
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-26
• Study First Submitted QC: 2013-06-27
• Study First Posted: 2013-06-28
• Study Start: 2013-08
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-07
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metacognitive therapy	Metacognitive therapy	The treatment is based on the generic manual by Wells (2009).
Cognitive behavorial therapy	Cognitive behavioral therapy	CBT includes the diagnose specific manuals for panic disorder (Clark, 1986), Social Phobia (Clark \& Wells, 1995) and PTSD (Foa, 2007).

Primary Outcome Measures

Name	Time	Method
Anxiety Disorders Interview Schedule for DSM-IV-Lifetime Version	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)	PRE/POST/weekly and 1 year follow up

Secondary Outcome Measures

Name	Time	Method
Dysfunctional emotion regulations scale (DERS; Graz & Roemer, 2004)	Pre/Post/ and 1 year follow up
Cognitive attentional syndrome 1 (CAS1; Wells, 2009)	Pre/Post/weekly 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
The Inventory of Interpersonal Problems (IIP 64 C; Horowitz et al., 1988)	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
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
Youngs Schema Questionnaire YSQ -75 (Young, 1998)	Pre/Post and 1 year follow up
SF 36	Pre/Post and 1 year follow up
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
The Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger & Borkovec, 1990)	Pre/Post and 1 year follow up

Trial Locations

Locations (1)

Modum Bad; 🇳🇴 Vikersund, Buskerud, Norway