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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Metacognitive therapy
* Behavioral: EMDR
* Behavioral: Treatment as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metacognitive therapy<br>The focus of metacognitive therapy (MCT) is on metacognitive beliefs thought to underlie the development and maintenance of posttraumatic symptomatology. | Behavioral: Metacognitive therapy<br>* 8-12 sessions of manualized metacognitive therapy<br>|
| Active Comparator: EMDR<br>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<br>* 8-12 sessions of manualized EMDR<br>|
| Active Comparator: Treatment as usual<br>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<br>* 8-12 sessions of treatment of usual<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posttraumatic Stress Disorder Scale (PDS) |  | 8-12 weeks post-treatment | 
| Posttraumatic Stress Disorder Scale (PDS) |  | 12 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Disorders Interview Schedule (ADIS-IV) |  | Pre-treatment/baseline; 8-12 weeks post-treatment | 
| PTSD Symptom Scale - Interview (PSS-I) |  | Pre-treatment/baseline; 8-12 weeks post-treatment | 
| Impact of Event Scale - Revised (IES-R) |  | Pre-treatment/baseline; 8-12 weeks post-treatment; 12 month follow-up | 
| Beck Anxiety Inventory (BAI) |  | Pre-treatment/baseline; 8-12 weeks post-treatment; 12 month follow-up | 
| Beck Depression Inventory (BDI-II) |  | Pre-treatment/baseline; 8-12 weeks post-treatment; 12 month follow-up | 
| Metacognitions Questionnaire - 30 (MCQ-30) | Process outcome / mediator measure | Pre-treatment/baseline; weekly; 8-12 weeks post-treatment | 
| Posttraumatic Cognitions Inventory (PTCI) | Process outcome / mediator measure | Pre-treatment/baseline; weekly; 8-12 weeks post-treatment | 
| Session Rating Scale (SRS) | Process outcome / mediator measure | Pre-treatment/baseline; weekly; 8-12 weeks post-treatment | 
| Inventory of Interpersonal Problems (IIP-64-C) |  | Pre-treatment/baseline; 8-12 weeks post-treatment; 12 month follow-up | 
| Posttraumatic Stress Disorder Scale (PDS) |  | Weekly | 
| WHO-5 Well-Being Index |  | Pre-treatment/baseline; 8-12 weeks post-treatment; 12 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metacognitive therapy, Eye Movement Desensitization Reprocessing (EMDR), Cognitive therapy