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

Primary Purpose

Mixed Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Metacognitive therapy
Cognitive behavioral therapy
Sponsored by
Modum Bad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mixed Anxiety Disorders focused on measuring MCT, Metacognitive therapy, Anxiety disorders, Transdiagnostic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Modum Bad

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Metacognitive therapy

Cognitive behavorial therapy

Arm Description

The treatment is based on the generic manual by Wells (2009).

CBT includes the diagnose specific manuals for panic disorder (Clark, 1986), Social Phobia (Clark & Wells, 1995) and PTSD (Foa, 2007).

Outcomes

Primary Outcome Measures

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.
Beck Anxiety Inventory (BAI)

Secondary Outcome Measures

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

Full Information

First Posted
June 26, 2013
Last Updated
March 7, 2016
Sponsor
Modum Bad
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1. Study Identification

Unique Protocol Identification Number
NCT01889342
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Modum Bad

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mixed Anxiety Disorders
Keywords
MCT, Metacognitive therapy, Anxiety disorders, Transdiagnostic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metacognitive therapy
Arm Type
Experimental
Arm Description
The treatment is based on the generic manual by Wells (2009).
Arm Title
Cognitive behavorial therapy
Arm Type
Active Comparator
Arm Description
CBT includes the diagnose specific manuals for panic disorder (Clark, 1986), Social Phobia (Clark & Wells, 1995) and PTSD (Foa, 2007).
Intervention Type
Behavioral
Intervention Name(s)
Metacognitive therapy
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy
Primary Outcome Measure Information:
Title
Anxiety Disorders Interview Schedule for DSM-IV-Lifetime Version
Description
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.
Time Frame
PRE/POST/1 year follow up
Title
Beck Anxiety Inventory (BAI)
Time Frame
PRE/POST/weekly and 1 year follow up
Secondary Outcome Measure Information:
Title
The Symptom Checklist 90(SCL90; Derogatis et al., 1996)
Time Frame
Pre/Post/1 year follow up
Title
The Patient Health Questionnaire depression module (PHQ 9; Spitzer et al., 1999)
Time Frame
Pre/Post and 1 year follow up
Title
Metacognitions Questionnaire- 30 (MCQ-30; Wells & Cartwright-Hatton, 2003)
Time Frame
Pre/Post/weekly and 1 year follow up
Title
Working Alliance Inventory (WAI; Horwath & Greenberg, 1989)
Time Frame
Pre/Post/weekly and 1 year follow up
Title
Cognitive attentional syndrome 1 (CAS1; Wells, 2009)
Time Frame
Pre/Post/weekly and 1 year follow up
Title
The Repetitive Thinking Questionnaire(RTQ; McEvoy et al., 2010)
Time Frame
Pre/Post and 1 year follow up
Title
PTSD Symptom scale Self Report (PSSR; Foa et al., 1993)
Time Frame
Pre/Post and 1 year follow up
Title
Social Phobia Inventory (SPIN; Connor et al., 2000)
Time Frame
Pre/Post and 1 year follow up
Title
Mobility inventory (MI; Chambless, 1985)
Time Frame
Pre/Post and 1 year follow up
Title
SF 36
Time Frame
Pre/Post and 1 year follow up
Title
The Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger & Borkovec, 1990)
Time Frame
Pre/Post and 1 year follow up
Title
Youngs Schema Questionnaire YSQ -75 (Young, 1998)
Time Frame
Pre/Post and 1 year follow up
Title
The Inventory of Interpersonal Problems (IIP 64 C; Horowitz et al., 1988)
Time Frame
Pre/Post and 1 year follow up
Title
Dysfunctional emotion regulations scale (DERS; Graz & Roemer, 2004)
Time Frame
Pre/Post/ and 1 year follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asle Hoffart, Ph.D
Organizational Affiliation
Modum Bad and University of Oslo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sverre Urnes Johnson, MA
Organizational Affiliation
Modum Bad and University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Modum Bad
City
Vikersund
State/Province
Buskerud
ZIP/Postal Code
3370
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
28541060
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.
Results Reference
derived

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

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