Treatment of Posttraumatic Stress Disorder (PTSD) in Adult Survivors of Early Chronic Interpersonal Trauma

NCT01443182 | Completed

• 1 other identifier: NL31098.097.10
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Eye movement desensitization and reprocessing (EMDR) and trauma-focused cognitive-behavioural therapy (TF-CBT) have both been found to be effective in treating post-traumatic stress disorder (PTSD) following single-event traumas and to be more effective than pure anxiety management or stabilization treatments. However, much less is known about the efficacy of the different treatment approaches in survivors of repeated or chronic interpersonal trauma. Recent evidence suggests that a combination of stabilization treatment + TF-CBT is efficacious in this population. Although EMDR is also often used in survivors of chronic interpersonal trauma, evidence on its efficacy are still poor. The aim of the current study is to compare the efficacy of (1) stabilization + TF-CBT and (2) stabilization + EMDR using a randomized controlled trial in a routine clinical setting.

Conditions

Posttraumatic Stress Disorder (PTSD)

Outcome Measures

Primary Outcomes (2)

• Clinician Administered PTSD Scale (CAPS)

  Pre- (baseline) and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up))

• Posttraumatic Diagnostic Scale (PDS)

  Pre- (baseline) and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up). Before each treatment session

Secondary Outcomes (5)

• Beck Depression Inventory (BDI)

  Pre- (baseline), after the first 8 treatment sessions and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up))

• Beck Anxiety Inventory (BAI)

  Pre- (baseline), after the first 8 treatment sessions and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up))

• Dissociative Experiences Scale (DES)

  Pre- (baseline), after the first 8 treatment sessions and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up))

• Difficulties in Emotion Regulation Scale (DERS)

  Pre- (baseline), after the first 8 treatment sessions and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up))

• Inventory of Interpersonal Problems (IIP)

  Pre- (baseline), after the first 8 treatment sessions and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up))

Study Arms (2)

STAIR + MPE

EXPERIMENTAL

A two-phased treatment with Skills Training in Affective and Interpersonal Regulation (STAIR) in Phase 1 en modified prolonged exposure (MPE) in Phase 2

Behavioral: STAIR; Behavioral: MPE

STAIR + EMDR

ACTIVE COMPARATOR

a two-phase treatment Phase 1: Skills Training in Affective and Interpersonal Regulation (STAIR) Phase 2: Eye Movement Desensitization and Reprocessing (EMDR)

Behavioral: STAIR; Behavioral: EMDR

Interventions

STAIR BEHAVIORAL

Skills Training in Affective and Interpersonal Regulation

STAIR + EMDR; STAIR + MPE

MPE BEHAVIORAL

Modified prolonged exposure (MPE)

STAIR + MPE

EMDR BEHAVIORAL

Eye movement desensitization and reprocessing

STAIR + EMDR

Eligibility Criteria

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

You may qualify if:

• meeting DSM-IV criteria for PTSD
• having experienced repeated or chronic interpersonal trauma (e.g., sexual or physical abuse)
• at least 18 years of age
• having sufficient fluency in Dutch to complete treatment and research protocol
• participants using prescribed anti-depressant medication are required to be on a stable dose for at least 2 weeks before the beginning of treatment and remain on this dose throughout the treatment.

You may not qualify if:

• psychiatric problems that may interfere with the study participation or that require more intensive care than can be offered in the present study, including dementia, psychotic symptoms, depression with suicidal ideation, full-blown borderline personality disorder, substance dependence
• current use of tranquilizers

Sponsors & Collaborators

• VU University of Amsterdam: lead

Study Sites (1)

PsyQ

Zaandam, Netherlands

Location

Related Publications (1)

• Wigard I, Meyerbroker K, Ehring T, Topper M, Arntz A, Emmelkamp P. Skills training followed by either EMDR or narrative therapy for posttraumatic stress disorder in adult survivors of childhood abuse: a randomized controlled trial. Eur J Psychotraumatol. 2024;15(1):2332104. doi: 10.1080/20008066.2024.2332104. Epub 2024 Apr 17.

  PMID: 38629403 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Eye Movement Desensitization Reprocessing

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

• Thomas Ehring, PhD

  University of Amsterdam

  STUDY CHAIR

• Katharina Meyerbröker

  University of Amsterdam

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 27, 2011
• First Posted: September 29, 2011
• Study Start: September 1, 2011
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 13, 2018

Record last verified: 2018-09

Locations

NL (1)