Improving PTSD Treatments for Adults With Childhood Trauma

Post Traumatic Stress Disorder Clinical Trial

— IMPACT  

Official title:

Improving PTSD Treatments for Adults With Childhood Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03194113
• Other study ID #: P16-144
• Status: Completed
• Phase: N/A
• Start date: December 1, 2016
• Est. completion date: December 19, 2019

Study information

• Verified date: February 2021
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 19, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Trauma-focused treatment
Weekly sessions
• Emotion regulation training
Managing and tolerating negative emotions, e.g. anger, sadness. Weekly sessions; preparatory to Prolonged exposure treatment
• Intensive Trauma-focused treatment
Intensive version (3 sessions per week) of Trauma-focused treatment

Locations

Country	Name	City	State
Netherlands	Leiden University - Institute of Psychology	Leiden	Zuid-Holland
Netherlands	PsyQ department of psychotrauma	The Hague	Zuid-Holland

Sponsors (4)

Lead Sponsor	Collaborator
Leiden University	PsyQ, Radboud University, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (5)

Cloitre M, Stovall-McClough KC, Nooner K, Zorbas P, Cherry S, Jackson CL, Gan W, Petkova E. Treatment for PTSD related to childhood abuse: a randomized controlled trial. Am J Psychiatry. 2010 Aug;167(8):915-24. doi: 10.1176/appi.ajp.2010.09081247. Epub 2010 Jul 1. — View Citation

Cloitre, M., Courtois, C.A., Ford, J.D., Green, B.L., Alexander, P., Briere, J. et al. (2012). The ISTSS Expert Consensus Treatment Guidelines for Complex PTSD in Adults. http://www.istss.org/AM/Template.cmf?Section=ISTSS_Complex_PTSD_Treatment_Guidelines&Template=/CM/ContentDisplay.cfm&ContentID=5185

Ehlers A, Hackmann A, Grey N, Wild J, Liness S, Albert I, Deale A, Stott R, Clark DM. A randomized controlled trial of 7-day intensive and standard weekly cognitive therapy for PTSD and emotion-focused supportive therapy. Am J Psychiatry. 2014 Mar;171(3):294-304. doi: 10.1176/appi.ajp.2013.13040552. — View Citation

Hendriks, L., & Van Minnen, A. (2014). What to do with treatment failures: Intensive (Prolonged) Exposure treatment for PTSD. Presentation at EABCT Conference The Hague.

Zayfert C, Deviva JC, Becker CB, Pike JL, Gillock KL, Hayes SA. Exposure utilization and completion of cognitive behavioral therapy for PTSD in a "real world" clinical practice. J Trauma Stress. 2005 Dec;18(6):637-45. — View Citation

Outcome

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