Clinical trial NCT01889342: Metacognitive Therapy Versus Cognitive Behavioral Therapy for Mixed Anxiety Disorders: A Randomized Controlled Trial.
Official title: Metacognitive Therapy Versus Cognitive Behavioral Therapy for Mixed Anxiety Disorders: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mixed Anxiety Disorders
Keywords: MCT
Metacognitive therapy
Anxiety disorders
Transdiagnostic
Lead sponsor: Modum Bad
Sponsor class: OTHER
First posted: 2013-06-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Anxiety Disorders Interview Schedule for DSM-IV-Lifetime Version
timeFrame: PRE/POST/1 year follow up
measure: Beck Anxiety Inventory (BAI)
timeFrame: PRE/POST/weekly and 1 year follow up
Secondary outcomes:
measure: The Symptom Checklist 90(SCL90; Derogatis et al., 1996)
timeFrame: Pre/Post/1 year follow up
measure: The Patient Health Questionnaire depression module (PHQ 9; Spitzer et al., 1999)
timeFrame: Pre/Post and 1 year follow up
measure: Metacognitions Questionnaire- 30 (MCQ-30; Wells & Cartwright-Hatton, 2003)
timeFrame: Pre/Post/weekly and 1 year follow up
measure: Working Alliance Inventory (WAI; Horwath & Greenberg, 1989)
timeFrame: Pre/Post/weekly and 1 year follow up
measure: Cognitive attentional syndrome 1 (CAS1; Wells, 2009)
timeFrame: Pre/Post/weekly and 1 year follow up
measure: The Repetitive Thinking Questionnaire(RTQ; McEvoy et al., 2010)
timeFrame: Pre/Post and 1 year follow up
measure: PTSD Symptom scale Self Report (PSSR; Foa et al., 1993)
timeFrame: Pre/Post and 1 year follow up
measure: Social Phobia Inventory (SPIN; Connor et al., 2000)
timeFrame: Pre/Post and 1 year follow up
measure: Mobility inventory (MI; Chambless, 1985)
timeFrame: Pre/Post and 1 year follow up
measure: SF 36
timeFrame: Pre/Post and 1 year follow up
measure: The Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger & Borkovec, 1990)
timeFrame: Pre/Post and 1 year follow up
measure: Youngs Schema Questionnaire YSQ -75 (Young, 1998)
timeFrame: Pre/Post and 1 year follow up
measure: The Inventory of Interpersonal Problems (IIP 64 C; Horowitz et al., 1988)
timeFrame: Pre/Post and 1 year follow up
measure: Dysfunctional emotion regulations scale (DERS; Graz & Roemer, 2004)
timeFrame: Pre/Post/ and 1 year follow up
Other outcomes:
Locations:
city: Vikersund
country: Norway
facility: Modum Bad
state: Buskerud
Study officials:
affiliation: Modum Bad and University of Oslo
name: Asle Hoffart, Ph.D
role: STUDY_CHAIR
affiliation: Modum Bad and University of Oslo
name: Sverre Urnes Johnson, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.