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

NCT01955590 | Completed

• 1 other identifier: PTSD-NTNU-1
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Keywords

Metacognitive therapy; Eye Movement Desensitization Reprocessing (EMDR); Cognitive therapy

Outcome Measures

Primary Outcomes (2)

• Posttraumatic Stress Disorder Scale (PDS)

  8-12 weeks post-treatment

• Posttraumatic Stress Disorder Scale (PDS)

  12 month follow-up

Secondary Outcomes (11)

• 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

Other Outcomes (1)

• Posttraumatic Stress Disorder Scale (PTSD-S)

  Pre-treatment/baseline; weekly; 8-12 weeks post-treatment

Study Arms (3)

Metacognitive therapy

EXPERIMENTAL

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

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.

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.

Behavioral: Treatment as usual

Interventions

Metacognitive therapy BEHAVIORAL

8-12 sessions of manualized metacognitive therapy

Metacognitive therapy

EMDR BEHAVIORAL

8-12 sessions of manualized EMDR

EMDR

Treatment as usual BEHAVIORAL

8-12 sessions of treatment of usual

Treatment as usual

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead

Study Sites (1)

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

Trondheim, 7040, Norway

Location

Related Publications (2)

• 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.

  PMID: 29310718 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.

  PMID: 29510757 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Eye Movement Desensitization Reprocessing; Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Hans M Nordahl, Prof

  Department of Psychology, Norwegian University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: October 7, 2013
• Study Start: November 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: March 15, 2019
• Last Updated: April 3, 2019

Record last verified: 2018-04

Locations

NO (1)