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A Randomized Controlled Trial of Metacognitive Therapy and EMDR for Posttraumatic Stress Disorder

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ClinicalTrials.gov Identifier: NCT01955590
Recruitment Status : Completed
First Posted : October 7, 2013
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief Summary:
Posttraumatic stress disorder (PTSD) is a frequently occurring and often debilitating anxiety disorder resulting from exposure to trauma. Trauma-focused cognitive-behavioural therapies, such as Eye movement desensitization and reprocessing (EMDR), are generally considered to be evidence-based treatments for PTSD. Although a majority of patients achieve improvement, a substantial minority either drop out of treatment, present with residual symptoms following treatment or fail to make any improvement. Furthermore, a substantial portion of the clinical trials on PTSD is characterised by major methodological limitations. In addition, there's a pressing need for research on mediators of treatment outcome. Taken together, these results highlight the need for methodological rigorous and stringent clinical trials comparing treatment modalities for PTSD. The first aim of this study is to investigate whether a treatment not based on the principles of exposure, i.e. metacognitive therapy (MCT) is as efficient as exposure-based treatments. The second aim to elucidate potential mediators of treatments effects by incorporating process-related variables.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: Metacognitive therapy Behavioral: EMDR Behavioral: Treatment as usual Not Applicable

Detailed Description:

EMDR is based on the assumption that posttraumatic symptoms are due to the traumatic experience(s) being stored in an unprocessed way disconnected from existing memory networks. The procedure in EMDR is postulated to facilitate the processing of the traumatic memory into existing memory networks. There is currently no empirical knowledge as to the therapeutic mechanisms of EMDR, but the protocol overlaps with core components of cognitive behavior therapy (CBT), such as imaginal exposure and cognitive restructuring of negative trauma-related cognitions. Thus, EMDR could be viewed as a form of CBT, although its originator maintains that it is a distinct treatment. EMDR is usually considered an evidence-based treatment of PTSD.

MCT is one of the new approaches in the treatment of PTSD. The metacognitive model posits that adaptation following exposure to trauma depends on metacognitive beliefs that guide how the individual interprets and responds to posttraumatic symptoms and can lead to styles of thinking that facilitate or impede emotional processing. MCT focuses on "unlocking" or removing the barriers to natural adaptation. This equips the client with general skills and therefore protects the individual from the risk of any future re-traumatisation. In contrast to EMDR, MCT does not involve proscribed exposure exercises or restructuring of negative trauma-related cognitions.

In addition we will include a group of 30 patients matched for age, gender and personality disorders receiving treatment as usual (TaU) in an outpatient setting as a non-randomized comparative control condition.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Metacognitive Therapy and Eye Movement Desensitization and Reprocessing for Posttraumatic Stress Disorder
Actual Study Start Date : November 2012
Actual Primary Completion Date : December 2017
Actual Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Metacognitive therapy
The focus of metacognitive therapy (MCT) is on metacognitive beliefs thought to underlie the development and maintenance of posttraumatic symptomatology.
Behavioral: Metacognitive therapy
8-12 sessions of manualized metacognitive therapy

Active Comparator: EMDR
Eye movement desensitization reprocessing (EMDR): participant is asked to focus on trauma-related imagery, negative cognitions and body sensations while simultaneously focusing attention to a bilateral physical stimulation.
Behavioral: EMDR
8-12 sessions of manualized EMDR

Active Comparator: Treatment as usual
A group of 30 patients matched for age, gender and personality disorders receiving treatment as usual (TaU) in an outpatient setting will be included as a non-randomized comparative control condition.
Behavioral: Treatment as usual
8-12 sessions of treatment of usual




Primary Outcome Measures :
  1. Posttraumatic Stress Disorder Scale (PDS) [ Time Frame: 8-12 weeks post-treatment ]
  2. Posttraumatic Stress Disorder Scale (PDS) [ Time Frame: 12 month follow-up ]

Secondary Outcome Measures :
  1. Anxiety Disorders Interview Schedule (ADIS-IV) [ Time Frame: Pre-treatment/baseline; 8-12 weeks post-treatment ]
  2. PTSD Symptom Scale - Interview (PSS-I) [ Time Frame: Pre-treatment/baseline; 8-12 weeks post-treatment ]
  3. Impact of Event Scale - Revised (IES-R) [ Time Frame: Pre-treatment/baseline; 8-12 weeks post-treatment; 12 month follow-up ]
  4. Beck Anxiety Inventory (BAI) [ Time Frame: Pre-treatment/baseline; 8-12 weeks post-treatment; 12 month follow-up ]
  5. Beck Depression Inventory (BDI-II) [ Time Frame: Pre-treatment/baseline; 8-12 weeks post-treatment; 12 month follow-up ]
  6. Metacognitions Questionnaire - 30 (MCQ-30) [ Time Frame: Pre-treatment/baseline; weekly; 8-12 weeks post-treatment ]
    Process outcome / mediator measure

  7. Posttraumatic Cognitions Inventory (PTCI) [ Time Frame: Pre-treatment/baseline; weekly; 8-12 weeks post-treatment ]
    Process outcome / mediator measure

  8. Session Rating Scale (SRS) [ Time Frame: Pre-treatment/baseline; weekly; 8-12 weeks post-treatment ]
    Process outcome / mediator measure

  9. Inventory of Interpersonal Problems (IIP-64-C) [ Time Frame: Pre-treatment/baseline; 8-12 weeks post-treatment; 12 month follow-up ]
  10. Posttraumatic Stress Disorder Scale (PDS) [ Time Frame: Weekly ]
  11. WHO-5 Well-Being Index [ Time Frame: Pre-treatment/baseline; 8-12 weeks post-treatment; 12 month follow-up ]

Other Outcome Measures:
  1. Posttraumatic Stress Disorder Scale (PTSD-S) [ Time Frame: Pre-treatment/baseline; weekly; 8-12 weeks post-treatment ]
    Only administered in the MCT treatment arm



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a primary diagnosis of PTSD according to the Anxiety Disorders Interview Schedule (ADIS-IV)
  • not previously received EMDR or MCT for this diagnosis
  • not actively suicidal, presenting with suicidal ideation, psychotic or suffering from severe depression
  • no evidence of alcohol or drug dependence
  • Symptom chronicity of >3 months post-trauma

Exclusion Criteria:

  • PTSD is not the primary diagnosis
  • expressing suicidal ideation, actively psychotic, or engaging in overt self-harm
  • Evidence of alcohol or drug dependence requiring treatment in its own right
  • Borderline personality disorder
  • Symptom chronicity <3 months post-trauma
  • no ability to understand or speak Norwegian

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): NCT01955590


Locations
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Norway
Outpatient speciality clinic for PTSD and other trauma-related emotional disorders at Østmarka, St. Olav University Hospital
Trondheim, Norway, 7040
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
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Study Director: Hans M Nordahl, Prof Department of Psychology, Norwegian University of Science and Technology

Publications:
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01955590     History of Changes
Other Study ID Numbers: PTSD-NTNU-1
First Posted: October 7, 2013    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Norwegian University of Science and Technology:
Metacognitive therapy
Eye Movement Desensitization Reprocessing (EMDR)
Cognitive therapy

Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders