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

• Sponsor: VU University of Amsterdam (Other)
• Overall Status: Completed
• CT.gov ID: NCT01443182
• Collaborator: (none)
• Enrollment: 68
• Location: 1
• Arms: 2
• Actual Duration (Months): 57
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder (PTSD)	Behavioral: STAIR; Behavioral: MPE; Behavioral: EMDR	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment of PTSD in Adult Survivors of Early Chronic Interpersonal Trauma
• Actual Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Behavioral: STAIR; Skills Training in Affective and Interpersonal Regulation; Behavioral: MPE; Modified prolonged exposure (MPE)
Active Comparator: STAIR + EMDR a two-phase treatment Phase 1: Skills Training in Affective and Interpersonal Regulation (STAIR) Phase 2: Eye Movement Desensitization and Reprocessing (EMDR)	Behavioral: STAIR; Skills Training in Affective and Interpersonal Regulation; Behavioral: EMDR; Eye movement desensitization and reprocessing

Outcome Measures

Primary Outcome Measures

1. 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))]

2. 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

1. 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))]

2. 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))]

3. 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))]

4. 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))]

5. 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))]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PsyQ	Zaandam		Netherlands

Sponsors and Collaborators

• VU University of Amsterdam

Investigators

• Study Chair: Thomas Ehring, PhD, University of Amsterdam
• Study Chair: Katharina Meyerbröker, University of Amsterdam

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Paul M.G.Emmelkamp, Professor, University of Amsterdam
• ClinicalTrials.gov Identifier: NCT01443182
• Other Study ID Numbers: NL31098.097.10
• First Posted: Sep 29, 2011
• Last Update Posted: Sep 13, 2018
• Last Verified: Sep 1, 2018

• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Sep 13, 2018