Clinical trial NCT03194113: Improving PTSD Treatments for Adults With Childhood Trauma
Official title: Improving PTSD Treatments for Adults With Childhood Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
name: PsyQ
name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2017-06-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: PTSD symptom severity
timeFrame: 16 weeks
Secondary outcomes:
measure: Depressive symptom severity
timeFrame: 16 weeks
measure: Quality of Life score
timeFrame: 16 weeks
measure: Responder rate
timeFrame: 16 weeks
measure: Dropout rate
timeFrame: 16 weeks
measure: Emotion regulation
timeFrame: 16 weeks
measure: Self-reported PTSD symptoms
timeFrame: 16 weeks
measure: Interpersonal difficulties
timeFrame: 16 weeks
measure: Self-concept
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University - Institute of Psychology
state: Zuid-Holland
city: The Hague
country: Netherlands
facility: PsyQ department of psychotrauma
state: Zuid-Holland
Study officials:
affiliation: head of department of clinical psychology
name: Willem Van Der Does, PdhD
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1002/jts.20072.
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.
citation: 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.
citation: 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.
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
citation: Oprel DAC, Hoeboer CM, Schoorl M, de Kleine RA, Cloitre M, Wigard IG, van Minnen A, van der Does W. Effect of Prolonged Exposure, intensified Prolonged Exposure and STAIR+Prolonged Exposure in patients with PTSD related to childhood abuse: a randomized controlled trial. Eur J Psychotraumatol. 2021 Jan 15;12(1):1851511. doi: 10.1080/20008198.2020.1851511. eCollection 2021.
citation: Oprel DAC, Hoeboer CM, Schoorl M, De Kleine RA, Wigard IG, Cloitre M, Van Minnen A, Van der Does W. Improving treatment for patients with childhood abuse related posttraumatic stress disorder (IMPACT study): protocol for a multicenter randomized trial comparing prolonged exposure with intensified prolonged exposure and phase-based treatment. BMC Psychiatry. 2018 Dec 12;18(1):385. doi: 10.1186/s12888-018-1967-5.