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

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Metacognitive therapy
EMDR
Treatment as usual
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Metacognitive therapy, Eye Movement Desensitization Reprocessing (EMDR), Cognitive therapy

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Metacognitive therapy

EMDR

Treatment as usual

Arm Description

The focus of metacognitive therapy (MCT) is on metacognitive beliefs thought to underlie the development and maintenance of posttraumatic symptomatology.

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.

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.

Outcomes

Primary Outcome Measures

Posttraumatic Stress Disorder Scale (PDS)
Posttraumatic Stress Disorder Scale (PDS)

Secondary Outcome Measures

Anxiety Disorders Interview Schedule (ADIS-IV)
PTSD Symptom Scale - Interview (PSS-I)
Impact of Event Scale - Revised (IES-R)
Beck Anxiety Inventory (BAI)
Beck Depression Inventory (BDI-II)
Metacognitions Questionnaire - 30 (MCQ-30)
Process outcome / mediator measure
Posttraumatic Cognitions Inventory (PTCI)
Process outcome / mediator measure
Session Rating Scale (SRS)
Process outcome / mediator measure
Inventory of Interpersonal Problems (IIP-64-C)
Posttraumatic Stress Disorder Scale (PDS)
WHO-5 Well-Being Index

Full Information

First Posted
September 24, 2013
Last Updated
April 1, 2019
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01955590
Brief Title
A Randomized Controlled Trial of Metacognitive Therapy and EMDR for Posttraumatic Stress Disorder
Official Title
A Randomized Controlled Trial of Metacognitive Therapy and Eye Movement Desensitization and Reprocessing for Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
March 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Metacognitive therapy, Eye Movement Desensitization Reprocessing (EMDR), Cognitive therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metacognitive therapy
Arm Type
Experimental
Arm Description
The focus of metacognitive therapy (MCT) is on metacognitive beliefs thought to underlie the development and maintenance of posttraumatic symptomatology.
Arm Title
EMDR
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Metacognitive therapy
Intervention Description
8-12 sessions of manualized metacognitive therapy
Intervention Type
Behavioral
Intervention Name(s)
EMDR
Intervention Description
8-12 sessions of manualized EMDR
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
8-12 sessions of treatment of usual
Primary Outcome Measure Information:
Title
Posttraumatic Stress Disorder Scale (PDS)
Time Frame
8-12 weeks post-treatment
Title
Posttraumatic Stress Disorder Scale (PDS)
Time Frame
12 month follow-up
Secondary Outcome Measure Information:
Title
Anxiety Disorders Interview Schedule (ADIS-IV)
Time Frame
Pre-treatment/baseline; 8-12 weeks post-treatment
Title
PTSD Symptom Scale - Interview (PSS-I)
Time Frame
Pre-treatment/baseline; 8-12 weeks post-treatment
Title
Impact of Event Scale - Revised (IES-R)
Time Frame
Pre-treatment/baseline; 8-12 weeks post-treatment; 12 month follow-up
Title
Beck Anxiety Inventory (BAI)
Time Frame
Pre-treatment/baseline; 8-12 weeks post-treatment; 12 month follow-up
Title
Beck Depression Inventory (BDI-II)
Time Frame
Pre-treatment/baseline; 8-12 weeks post-treatment; 12 month follow-up
Title
Metacognitions Questionnaire - 30 (MCQ-30)
Description
Process outcome / mediator measure
Time Frame
Pre-treatment/baseline; weekly; 8-12 weeks post-treatment
Title
Posttraumatic Cognitions Inventory (PTCI)
Description
Process outcome / mediator measure
Time Frame
Pre-treatment/baseline; weekly; 8-12 weeks post-treatment
Title
Session Rating Scale (SRS)
Description
Process outcome / mediator measure
Time Frame
Pre-treatment/baseline; weekly; 8-12 weeks post-treatment
Title
Inventory of Interpersonal Problems (IIP-64-C)
Time Frame
Pre-treatment/baseline; 8-12 weeks post-treatment; 12 month follow-up
Title
Posttraumatic Stress Disorder Scale (PDS)
Time Frame
Weekly
Title
WHO-5 Well-Being Index
Time Frame
Pre-treatment/baseline; 8-12 weeks post-treatment; 12 month follow-up
Other Pre-specified Outcome Measures:
Title
Posttraumatic Stress Disorder Scale (PTSD-S)
Description
Only administered in the MCT treatment arm
Time Frame
Pre-treatment/baseline; weekly; 8-12 weeks post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans M Nordahl, Prof
Organizational Affiliation
Department of Psychology, Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Outpatient speciality clinic for PTSD and other trauma-related emotional disorders at Østmarka, St. Olav University Hospital
City
Trondheim
ZIP/Postal Code
7040
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29310718
Citation
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. Erratum In: Trials. 2018 Mar 6;19(1):164.
Results Reference
background
PubMed Identifier
29510757
Citation
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.
Results Reference
background

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

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