Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metacognitive therapy | Experimental | The focus of metacognitive therapy (MCT) is on metacognitive beliefs thought to underlie the development and maintenance of posttraumatic symptomatology. |
|
| EMDR | Active Comparator | 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. |
|
| Treatment as usual | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metacognitive therapy | Behavioral | 8-12 sessions of manualized metacognitive therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Posttraumatic Stress Disorder Scale (PDS) | 8-12 weeks post-treatment | |
| Posttraumatic Stress Disorder Scale (PDS) | 12 month follow-up |
| 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| Posttraumatic Stress Disorder Scale (PTSD-S) | Only administered in the MCT treatment arm | Pre-treatment/baseline; weekly; 8-12 weeks post-treatment |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hans M Nordahl, Prof | Department of Psychology, Norwegian University of Science and Technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outpatient speciality clinic for PTSD and other trauma-related emotional disorders at Østmarka, St. Olav University Hospital | Trondheim | 7040 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29310718 | Background | Nordahl HM, Halvorsen JO, Hjemdal O, Ternava MR, Wells A. Metacognitive therapy vs. eye movement desensitization and reprocessing for posttraumatic stress disorder: study protocol for a randomized superiority trial. Trials. 2018 Jan 8;19(1):16. doi: 10.1186/s13063-017-2404-7. | |
| 29510757 | Background | Nordahl HM, Halvorsen JO, Hjemdal O, Ternava MR, Wells A. Correction to: Metacognitive therapy vs. eye movement desensitization and reprocessing for posttraumatic stress disorder: study protocol for a randomized superiority trial. Trials. 2018 Mar 6;19(1):164. doi: 10.1186/s13063-018-2536-4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D057169 | Eye Movement Desensitization Reprocessing |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D003887 | Desensitization, Psychologic |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| EMDR | Behavioral | 8-12 sessions of manualized EMDR |
|
| Treatment as usual | Behavioral | 8-12 sessions of treatment of usual |
|
| 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 |