NCT01889342

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 8, 2016

Status Verified

March 1, 2016

Enrollment Period

2.3 years

First QC Date

June 26, 2013

Last Update Submit

March 7, 2016

Conditions

Mixed Anxiety Disorders

Keywords

MCTMetacognitive therapyAnxiety disordersTransdiagnostic

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (14)

  • 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

  • +9 more secondary outcomes

Study Arms (2)

Metacognitive therapy

EXPERIMENTAL

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

Behavioral: Metacognitive therapy

Cognitive behavorial therapy

ACTIVE COMPARATOR

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

Behavioral: Cognitive behavioral therapy

Interventions

Metacognitive therapyBEHAVIORAL
Metacognitive therapy
Cognitive behavioral therapyBEHAVIORAL
Cognitive behavorial therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DSM IV diagnoses of SAD, PD/A or PTSD (CSR\>4)
  • Withdraw of all psychotropic medications before treatment

You may not qualify if:

  • Psychosis
  • Not willing to accept randomization
  • Comorbid conditions are in immediate need of treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Modum Bad

Vikersund, Buskerud, 3370, Norway

Location

Related Publications (1)

  • 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.

    PMID: 28541060DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Asle Hoffart, Ph.D

    Modum Bad and University of Oslo

    STUDY CHAIR

  • Sverre Urnes Johnson, MA

    Modum Bad and University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2013

First Posted

June 28, 2013

Study Start

August 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 8, 2016

Record last verified: 2016-03

Locations

NO(1)