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Completed

NCT Number: NCT01955590

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

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient speciality clinic for PTSD and other trauma-related emotional disorders at Østmarka, St. Olav University Hospital

Trondheim, 7040, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metacognitive Therapy

Behavioral

8-12 sessions of manualized metacognitive therapy

EMDR

Behavioral

8-12 sessions of manualized EMDR

Treatment as Usual

Behavioral

8-12 sessions of treatment of usual

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Official study title

A Randomized Controlled Trial of Metacognitive Therapy and Eye Movement Desensitization and Reprocessing for Posttraumatic Stress Disorder

Important dates

Study start
2012
Primary completion
2017
Study completion
2019
First posted
Oct 7, 2013
Registry last updated
Apr 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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