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

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ClinicalTrials.gov Identifier: NCT01608399
Recruitment Status : Completed
First Posted : May 31, 2012
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief Summary:
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 or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Metacognitive therapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Actual Study Start Date : March 2012
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Metacognitive therapy Behavioral: Metacognitive therapy
Metacognitive therapy, 10 weekly sessions of 45-60 minutes duration each
No Intervention: Waiting list control



Primary Outcome Measures :
  1. Change in depression [ Time Frame: baseline (before treatment), week 1-11, 12 months follow-up ]
    Hamilton Depression Rating Scale (HDRS-17; Hamilton, 1967)

  2. Change in diagnosis [ Time Frame: baseline (before treatment), week 11, 12 months follow-up ]
    SCID I and II (First et al., 1995, 1997)


Secondary Outcome Measures :
  1. Change in depression [ Time Frame: baseline (before treatment), week 1-11, 6 and 12 months follow-up ]
    Major Depressive Disorder Scale (MDD-S; Wells, 2009)

  2. Change in anxiety [ Time Frame: baseline (before treatment), week 1-11, 6 and 12 months follow-up ]
    Beck Anxiety Inventory (BAI; Beck et al., 1988)

  3. Change in automatic thought [ Time Frame: baseline (before treatment), week 11, 6 and 12 months follow-up ]
    Automatic Thought Questionnaire (ATQ; hollon & Kendall,

  4. Change in rumination [ Time Frame: baseline (before treatment), week 11, 6 and 12 months follow-up ]
    Rumination Response Scale (RRS; Nolen-Hoeksema & Morrow, 1991)

  5. Change in positive beliefs [ Time Frame: baseline (before treatment), week 11, 6 and 12 months follow-up ]
    Positive beliefs about Rumination (PBRS; Papageorgiou & Wells, 2001)

  6. Change in negative beliefs [ Time Frame: baseline (before treatment), week 11, 6 and 12 months follow-up ]
    Negative Beliefs about Rumination (NBRS; Papageorgiou & Wells, 2008)

  7. Change in metacognitions [ Time Frame: baseline (before treatment), week 11, 6 and 12 months follow-up ]
    Metacognitions Questionnaire-30 (MCQ-30; Wells & Cartwright-Hatton, 2003)

  8. Change in resilience [ Time Frame: baseline (before treatment), week 11, 6 and 12 months follow-up ]
    Resilience Scale for Adults (RSA; Friborg & Hjemdal, 2003)

  9. Change in interpersonal problems [ Time Frame: baseline (before treatment), week 11, 6 and 12 months follow-up ]
    Inventory of Interpersonal Problems (IIP-64; Horowitz et al., 1988)

  10. Change in worry [ Time Frame: baseline (before treatment), week 11, 6 and 12 months follow-up ]
    Penn Scale Worry Questionnaire (PSWQ; Meyer et al., 1990)

  11. Quality of working alliance [ Time Frame: week 3 ]
    Working Alliance Inventory (Horvath & Greenberg, 1989)



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01608399


Locations
Norway
Department of psychology, Norwegian University of Science and Technology
Trondheim, Norway, 7491
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Study Director: Roger Hagen, PhD Norwegian University of Science and Technology

Publications of Results:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01608399     History of Changes
Other Study ID Numbers: MCTDEP
First Posted: May 31, 2012    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

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