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

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder (PTSD)
• Interventions: Behavioral: STAIR; Behavioral: MPE; Behavioral: EMDR

• Registration Number: NCT01443182
• Lead Sponsor: VU University of Amsterdam

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-27
• Study First Submitted QC: 2011-09-28
• Study First Posted: 2011-09-29
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-11
• Last Update Posted: 2018-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STAIR + MPE	STAIR	A two-phased treatment with Skills Training in Affective and Interpersonal Regulation (STAIR) in Phase 1 en modified prolonged exposure (MPE) in Phase 2
STAIR + MPE	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
STAIR + EMDR	EMDR	a two-phase treatment Phase 1: Skills Training in Affective and Interpersonal Regulation (STAIR) Phase 2: Eye Movement Desensitization and Reprocessing (EMDR)
STAIR + EMDR	STAIR	a two-phase treatment Phase 1: Skills Training in Affective and Interpersonal Regulation (STAIR) Phase 2: Eye Movement Desensitization and Reprocessing (EMDR)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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))
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))
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))
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))

Trial Locations

Locations (1)

PsyQ; 🇳🇱 Zaandam, Netherlands