Improving PTSD Treatments for Adults With Childhood Trauma

Not Applicable

Completed

• Conditions: Post Traumatic Stress Disorder

• Registration Number: NCT03194113
• Lead Sponsor: Leiden University

Brief Summary

The aim of this project is to investigate the effectiveness of phase-based trauma-focused therapy (PBT) and intensive trauma-focused therapy (I-TFT) for adult patients with PTSD related to childhood abuse.

We will carry out a RCT, randomizing 150 patients to receive either standard TFT, PBT or i-TFT. The effects will be assessed at two endpoints of treatment (4, 8 and 16 weeks) and after a 6 and 12 months follow-up in an intention-to-treat analysis.

Detailed Description

The Dutch treatment guidelines recommend trauma-focused treatment (TFT) for PTSD. In TFT, patients are exposed to trauma reminders that they typically avoid, until their emotional reactions decline. This treatment has been found very effective for some patients but there is much room for improvement, particularly in PTSD related to childhood abuse (CA-PTSD). Symptom exacerbation, non-attendance and dropout rates of up to 40% have been observed in patients with CA-PTSD.

Two alternative treatments have been proposed. Firstly, TFT may be preceded by emotion regulation and interpersonal skills training. This is called phase-based treatment (PBT). The rationale is that patients with CA-PTSD have affect regulation and interpersonal problems that interfere with effective delivery of TFT. These problems are rooted in the detrimental developmental effects of abuse (often by an attachment figure). PBT indeed resulted in more favorable outcomes and fewer dropouts. In international guidelines, PBT was recently recommended as treatment of choice for patients with CA-PTSD and comorbidity.

Another innovative treatment is intensive TFT (i-TFT), which means delivering TFT in 4 instead of 16 weeks. The condensed format enhances learning and prevents the buildup of anticipatory anxiety, which in turn affects the patients' motivation. Patients with CA-PTSD are also characterized by high psychosocial stressors, leading to problems with treatment attendance and compliance. The condensed format may improve motivation, attendance and compliance. I-TFT was recently tested in a case series in patients with CA-PTSD and in a randomized controlled trial (RCT) with patients with adulthood-related PTSD. Both studies had very low dropout rates (0-3%) and fast recovery.

The aim of the current study is to investigate the (cost)effectiveness of two innovative forms of trauma-focused therapy for patients with CA-PTSD: phase-based therapy (emotion regulation skills training followed bij PE) and intensive PE (i-PE). The effects will be assessed post-treatment and after a 6 and 12 months follow-up in an intention-to-treat analysis. Results will be disseminated and included in treatment guidelines. The ultimate goal is to improve quality of care and contribute to treatment innovation for this severely ill target population.

Study Timeline

• Study Start: 2016-12-01
• Study First Submitted: 2017-06-19
• Study First Submitted QC: 2017-06-19
• Study First Posted: 2017-06-21
• Primary Completion: 2019-04-15
• Study Completion: 2019-12-19
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Diagnosis of PTSD according to DSM-5, including at least one specific discrete memory of a traumatic event
• Multiple traumata related to childhood sexual/physical abuse that occurred before 18 years of age, and committed by a primary caretaker or an authority figure as index event
• Symptom severity: CAPS score > 25
• Sufficient fluency in Dutch to complete the treatment and research protocols

Exclusion Criteria

• Involved in legal procedures concerning admission or stay in The Netherlands
• Involvement in compensation issues
• Pregnancy
• Severe non-suicidal self-injury (NSSI) in the last two months (hospital referral required)
• Suicidality in the last 2 months
• Alcohol or drug dependence in last 2 months
• Cognitive impairment (estimated IQ < 70)
• Changes in psychotropic medication in the two months prior to inclusion
• Current psychological treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PTSD symptom severity	16 weeks	Clinician Administered Posttraumatic Stress Inventory (CAPS-5) total score

Secondary Outcome Measures

Name	Time	Method
Responder rate	16 weeks	Meeting pre-defined criteria for remission
Dropout rate	16 weeks	premature termination of treatment by patient
Quality of Life score	16 weeks	EQ5D5L total score
Emotion regulation	16 weeks	ICD-11 Trauma Questionnaire and Difficulties in Emotion Regulation Scale (DERS)
Self-reported PTSD symptoms	16 weeks	Post-traumatic Stress Disorder Checklist (PCL-5)
Interpersonal difficulties	16 weeks	ICD-11 Trauma Questionnaire and Inventory of Interpersonal Problems (IIP)
Self-concept	16 weeks	ICD-11 Trauma Questionnaire and Rosenberg self-esteem scale (RSS)
Depressive symptom severity	16 weeks	total score on Inventory of Depressive Symptomatology (IDS)

Trial Locations

Locations (2)

Leiden University - Institute of Psychology; 🇳🇱 Leiden, Zuid-Holland, Netherlands

PsyQ department of psychotrauma; 🇳🇱 The Hague, Zuid-Holland, Netherlands