Clinical Trial of the Effectiveness of Metacognitive Therapy in the Treatment of Patients With Major Depressive Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Norwegian University of Science and Technology
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01608399
First received: February 9, 2012
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

The main aim of this study is to (1) evaluate the effectiveness of metacognitive therapy for major depressive disorder. Additional aims are to (2) investigate patterns of change and the mechanisms of action involved during treatment, and to (3) examine the impact of meta-cognitions in the treatment and relapse prevention of depression.


Condition Intervention
Major Depressive Disorder
Behavioral: Metacognitive therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of the Effectiveness of Metacognitive Therapy (MCT) in the Treatment of Patients With Major Depressive Disorder (MDD)

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Change in depression [ Time Frame: baseline (before treatment), week 1-11, 12 months follow-up ] [ Designated as safety issue: No ]
    Hamilton Depression Rating Scale (HDRS-17; Hamilton, 1967)

  • Change in diagnosis [ Time Frame: baseline (before treatment), week 11, 12 months follow-up ] [ Designated as safety issue: No ]
    SCID I and II (First et al., 1995, 1997)


Secondary Outcome Measures:
  • Change in depression [ Time Frame: baseline (before treatment), week 1-11, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    Major Depressive Disorder Scale (MDD-S; Wells, 2009)

  • Change in anxiety [ Time Frame: baseline (before treatment), week 1-11, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    Beck Anxiety Inventory (BAI; Beck et al., 1988)

  • Change in automatic thought [ Time Frame: baseline (before treatment), week 11, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    Automatic Thought Questionnaire (ATQ; hollon & Kendall,

  • Change in rumination [ Time Frame: baseline (before treatment), week 11, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    Rumination Response Scale (RRS; Nolen-Hoeksema & Morrow, 1991)

  • Change in positive beliefs [ Time Frame: baseline (before treatment), week 11, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    Positive beliefs about Rumination (PBRS; Papageorgiou & Wells, 2001)

  • Change in negative beliefs [ Time Frame: baseline (before treatment), week 11, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    Negative Beliefs about Rumination (NBRS; Papageorgiou & Wells, 2008)

  • Change in metacognitions [ Time Frame: baseline (before treatment), week 11, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    Metacognitions Questionnaire-30 (MCQ-30; Wells & Cartwright-Hatton, 2003)

  • Change in resilience [ Time Frame: baseline (before treatament), week 11, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    Resilience Scale for Adults (RSA; Friborg & Hjemdal, 2003)

  • Change in interpersonal problems [ Time Frame: baseline (before treatment), week 11, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    Inventory of Interpersonal Problems (IIP-64; Horowitz et al., 1988)

  • Change in worry [ Time Frame: baseline (before treatment), week 11, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    Penn Scale Worry Questionnaire (PSWQ; Meyer et al., 1990)

  • Quality of working alliance [ Time Frame: week 3 ] [ Designated as safety issue: No ]
    Working Alliance Inventory (Horvath & Greenberg, 1989)


Estimated Enrollment: 50
Study Start Date: March 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metacognitive therapy Behavioral: Metacognitive therapy
Metacognitive therapy, 10 weekly sessions of 45-60 minutes duration each
No Intervention: Waiting list control

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major depressive disorder
  • 18 years or older
  • Signed written informed consent prior to entry in the study

Exclusion Criteria:

  • Known somatic disease
  • Psychosis
  • Current suicide intent
  • PTSD
  • Cluster A or cluster B personality disorder
  • Substance dependence
  • Not willing to accept random allocation
  • Not willing to withdraw psychotropic medication for a period of 4 weeks prior to entry to the trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608399

Contacts
Contact: Roger Hagen, PhD 73597407 roger.hagen@svt.ntnu.no
Contact: Odin Hjemdal, PhD 73597407 odin.hjemdal@svt.ntnu.no

Locations
Norway
Department of psychology, Norwegian University of Science and Technology Recruiting
Trondheim, Norway, 7491
Contact: Roger Hagen, PhD    +47 73597406    roger.hagen@svt.ntnu.no   
Principal Investigator: Roger Hagen, Ph.D         
Principal Investigator: Odin Hjemdal, Ph.D         
Principal Investigator: Truls Ryum, Ph.D         
Principal Investigator: Hans M Nordahl, Ph.D         
Principal Investigator: Leif EO Kennair, Ph.D         
Principal Investigator: Stian Solem, Ph.D         
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Study Director: Roger Hagen, PhD Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01608399     History of Changes
Other Study ID Numbers: MCTDEP
Study First Received: February 9, 2012
Last Updated: May 22, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian University of Science and Technology:
major depressive disorder
psychotherapy
metacognitive therapy

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 14, 2014