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

Posttraumatic Stress Disorder (PTSD) Clinical Trial

Official title:

Treatment of PTSD in Adult Survivors of Early Chronic Interpersonal Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01443182
• Other study ID #: NL31098.097.10
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: June 2016

Study information

• Verified date: September 2018
• Source: VU University of Amsterdam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• STAIR
Skills Training in Affective and Interpersonal Regulation
• MPE
Modified prolonged exposure (MPE)
• EMDR
Eye movement desensitization and reprocessing

Locations

Country	Name	City	State
Netherlands	PsyQ	Zaandam

Sponsors (1)

Lead Sponsor	Collaborator
VU University of Amsterdam

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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))
Primary	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	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))
Secondary	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))
Secondary	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))
Secondary	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))
Secondary	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))