Posttraumatic Stress DisorderNCT01955590
A Randomized Controlled Trial of Metacognitive Therapy and EMDR for Posttraumatic Stress Disorder
A study testing Metacognitive therapy, EMDR and Treatment as usual in people with Posttraumatic Stress Disorder, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Metacognitive therapy, EMDR and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2012to 15 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Outpatient speciality clinic for PTSD and other trauma-related emotional disorders at Østmarka, St. Olav University Hospital
Trondheim, 7040
About this study
Official title: A Randomized Controlled Trial of Metacognitive Therapy and Eye Movement Desensitization and Reprocessing 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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Metacognitive therapy, EMDR, Treatment as usual
- Keywords
- Metacognitive therapy, Eye Movement Desensitization Reprocessing (EMDR), Cognitive therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive therapyBehavioural
8-12 sessions of manualized metacognitive therapy
EMDRBehavioural
8-12 sessions of manualized EMDR
Treatment as usualBehavioural
8-12 sessions of treatment of usual
| Study group | Role | What they receive |
|---|---|---|
| Metacognitive therapy | Experimental | The focus of metacognitive therapy (MCT) is on metacognitive beliefs thought to underlie the development and maintenance of posttraumatic symptomatology. Receives: Behavioral: Metacognitive therapy |
| 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. Receives: Behavioral: EMDR |
| 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. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posttraumatic Stress Disorder Scale (PDS)
Measured: 8-12 weeks post-treatment
Posttraumatic Stress Disorder Scale (PDS)
Measured: 12 month follow-up
Secondary outcomes (11)
Anxiety Disorders Interview Schedule (ADIS-IV)
Measured: Pre-treatment/baseline; 8-12 weeks post-treatment
PTSD Symptom Scale - Interview (PSS-I)
Measured: Pre-treatment/baseline; 8-12 weeks post-treatment
Impact of Event Scale - Revised (IES-R)
Measured: Pre-treatment/baseline; 8-12 weeks post-treatment; 12 month follow-up
Beck Anxiety Inventory (BAI)
Measured: Pre-treatment/baseline; 8-12 weeks post-treatment; 12 month follow-up
Beck Depression Inventory (BDI-II)
Measured: Pre-treatment/baseline; 8-12 weeks post-treatment; 12 month follow-up
Metacognitions Questionnaire - 30 (MCQ-30)
Process outcome / mediator measure
Measured: Pre-treatment/baseline; weekly; 8-12 weeks post-treatment
Posttraumatic Cognitions Inventory (PTCI)
Process outcome / mediator measure
Measured: Pre-treatment/baseline; weekly; 8-12 weeks post-treatment
Session Rating Scale (SRS)
Process outcome / mediator measure
Measured: Pre-treatment/baseline; weekly; 8-12 weeks post-treatment
Inventory of Interpersonal Problems (IIP-64-C)
Measured: Pre-treatment/baseline; 8-12 weeks post-treatment; 12 month follow-up
Posttraumatic Stress Disorder Scale (PDS)
Measured: Weekly
WHO-5 Well-Being Index
Measured: Pre-treatment/baseline; 8-12 weeks post-treatment; 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2017
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans M Nordahl, Prof, Study director, Department of Psychology, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955590
- Sponsor's protocol ID
- PTSD-NTNU-1
- Status last verified
- Apr 2018
- First submitted
- 24 Sep 2013
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29310718Nordahl 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.
PubMed 29510757
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Metacognitive Therapy and Eye Movement Desensitization and Reprocessing for Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT01955590
- Acronym / sponsor ID
- PTSD-NTNU-1
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Metacognitive therapy, Eye Movement Desensitization Reprocessing (EMDR), Cognitive therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Nov 2012 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 7 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metacognitive therapy | Experimental | Behavioral: Metacognitive therapyThe focus of metacognitive therapy (MCT) is on metacognitive beliefs thought to underlie the development and maintenance of posttraumatic symptomatology. |
| EMDR | Active comparator | Behavioral: EMDREye 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 | Behavioral: Treatment as usualA 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metacognitive therapy8-12 sessions of manualized metacognitive therapy | Behavioural | Metacognitive therapy |
| EMDR8-12 sessions of manualized EMDR | Behavioural | EMDR |
| Treatment as usual8-12 sessions of treatment of usual | Behavioural | Treatment as usual |
Primary outcome
Posttraumatic Stress Disorder Scale (PDS)
Time frame: 8-12 weeks post-treatment
Posttraumatic Stress Disorder Scale (PDS)
Time frame: 12 month follow-up
11 secondary outcomes
Anxiety Disorders Interview Schedule (ADIS-IV)
Time frame: Pre-treatment/baseline; 8-12 weeks post-treatment
PTSD Symptom Scale - Interview (PSS-I)
Time frame: Pre-treatment/baseline; 8-12 weeks post-treatment
Impact of Event Scale - Revised (IES-R)
Time frame: Pre-treatment/baseline; 8-12 weeks post-treatment; 12 month follow-up
Beck Anxiety Inventory (BAI)
Time frame: Pre-treatment/baseline; 8-12 weeks post-treatment; 12 month follow-up
Beck Depression Inventory (BDI-II)
Time frame: Pre-treatment/baseline; 8-12 weeks post-treatment; 12 month follow-up
Metacognitions Questionnaire - 30 (MCQ-30)
Time frame: Pre-treatment/baseline; weekly; 8-12 weeks post-treatment
Posttraumatic Cognitions Inventory (PTCI)
Time frame: Pre-treatment/baseline; weekly; 8-12 weeks post-treatment
Session Rating Scale (SRS)
Time frame: Pre-treatment/baseline; weekly; 8-12 weeks post-treatment
Inventory of Interpersonal Problems (IIP-64-C)
Time frame: Pre-treatment/baseline; 8-12 weeks post-treatment; 12 month follow-up
Posttraumatic Stress Disorder Scale (PDS)
Time frame: Weekly
WHO-5 Well-Being Index
Time frame: Pre-treatment/baseline; 8-12 weeks post-treatment; 12 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Background: PubMed 29310718Nordahl 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.
- Background: PubMed 29510757Nordahl 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans M Nordahl, Prof study director
Department of Psychology, Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive therapy, EMDR and Treatment as usual in people with Posttraumatic Stress Disorder, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posttraumatic Stress Disorder Scale (PDS) (time frame: 8-12 weeks post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01955590, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2019.