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

NCT ID: NCT01443182

Last Updated: 2018-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Posttraumatic Stress Disorder (PTSD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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STAIR + MPE

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

Group Type EXPERIMENTAL

STAIR

Intervention Type BEHAVIORAL

Skills Training in Affective and Interpersonal Regulation

MPE

Intervention Type BEHAVIORAL

Modified prolonged exposure (MPE)

STAIR + EMDR

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

Group Type ACTIVE_COMPARATOR

STAIR

Intervention Type BEHAVIORAL

Skills Training in Affective and Interpersonal Regulation

EMDR

Intervention Type BEHAVIORAL

Eye movement desensitization and reprocessing

Interventions

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STAIR

Skills Training in Affective and Interpersonal Regulation

Intervention Type BEHAVIORAL

MPE

Modified prolonged exposure (MPE)

Intervention Type BEHAVIORAL

EMDR

Eye movement desensitization and reprocessing

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VU University of Amsterdam

OTHER

Sponsor Role lead

Responsible Party

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Paul M.G.Emmelkamp

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Ehring, PhD

Role: STUDY_CHAIR

University of Amsterdam

Katharina Meyerbröker

Role: STUDY_CHAIR

University of Amsterdam

Locations

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PsyQ

Zaandam, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 38629403 (View on PubMed)

Other Identifiers

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NL31098.097.10

Identifier Type: -

Identifier Source: org_study_id

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