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Randomized Controlled Trial
. 2018 Dec 12;18(1):385.
doi: 10.1186/s12888-018-1967-5.

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

D A C Oprel  1   2 , C M Hoeboer  1   2 , M Schoorl  3   4 , R A De Kleine  1 , I G Wigard  2   5 , M Cloitre  6   7 , A Van Minnen  8   9 , W Van der Does  1   2   10
Affiliations
Randomized Controlled Trial

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

D A C Oprel et al. BMC Psychiatry. .

Abstract

Background: Childhood abuse related posttraumatic stress disorder (CA-PTSD) is associated with a high burden of disease and with treatment response rates that leave room for improvement. One of the treatments for PTSD, prolonged exposure (PE), is effective but has high drop-out rates and remission rates are relatively low. An intensified form of PE (iPE) was associated with good response and low drop-out rates in PTSD and has not yet been tested in a controlled trial in CA-PTSD. Phase-based treatment (PBT), in which PE is preceded by skills training may improve overall outcomes in this population. We will assess the effectiveness and cost-effectiveness of standard PE, iPE and PBT in patients with CA-PTSD.

Methods/design: Multi-center randomized controlled trial. Treatment conditions are: prolonged exposure (PE; maximum of 16 sessions in 16 weeks); intensified PE (iPE; maximum of 12 sessions in four weeks and two booster sessions); phase-based treatment (PBT; maximum of eight sessions skills training followed by eight sessions PE in 16 weeks).

Primary outcome: Clinician-rated PTSD symptom severity.

Secondary outcomes: loss of PTSD diagnosis, self-reported PTSD symptom severity, comorbid symptom severity and quality of life. Moreover, we will examine cost-effectiveness and moderators and mediators of treatment outcome.

Target population: adults with CA-PTSD (N = 150). Assessments in weeks 0, 4, 8, 16, 26 and 52.

Discussion: Given that no consensus yet exists about the treatment guidelines for patients with CA-PTSD, the present study may have important implications for the treatment of CA-PTSD.

Trail registration: Registered at C.C.M.O. on Sept 7, 2016 (NL57984.058.16); retrospectively registered at June 21, 2017 at clinicaltrials.gov identifier: NCT03194113 .

Keywords: CA-PTSD; Childhood trauma; Intensive treatment; Phase-based treatment; Posttraumatic stress disorder; Prolonged exposure; STAIR; Trauma focused treatment.

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Conflict of interest statement

Ethics approval and consent to participate

All participants will provide written informed consent prior to enrollment. The research protocol has been approved by the Medical Ethical Committee of Leiden University Medical Center (NL57984.058.16).

Consent for publication

Not applicable.

Competing interests

Agnes van Minnen: Receives fees from teaching and supervising clinical psychologists and psychiatrists in psychological trauma and its treatment by means of seminars, workshops and conferences, and royalties of books (Boom Publishers). Marylene Cloitre: Receives fees from teaching and consulting with mental health professionals in psychological trauma and its treatment by means of workshops, conferences and royalties from books. All other authors declare to have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flowchart of the IMPACT study
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References

    1. Gilsanz P, Winning A, Koenen KC, Roberts AL, Sumner JA, Chen Q, Glymour MM, Rimm EB, Kubzansky LD. Post-traumatic stress disorder symptom duration and remission in relation to cardiovascular disease risk among a large cohort of women. Psychol Med. 2017;47(8):1370–1378. doi: 10.1017/S0033291716003378. - DOI - PMC - PubMed
    1. Coid J, Petruckevitch A, Feder G, Chung W-S, Richardson J, Moorey S. Relation between childhood sexual and physical abuse and risk of revictimisation in women: a cross-sectional survey. Lancet. 2001;358(9280):450–454. doi: 10.1016/S0140-6736(01)05622-7. - DOI - PubMed
    1. Farley M, Patsalides BM. Physical symptoms, posttraumatic stress disorder, and healthcare utilization of women with and without childhood physical and sexual abuse. Psychol Rep. 2001;89(3):595–606. doi: 10.2466/pr0.2001.89.3.595. - DOI - PubMed
    1. Gilbert R, Widom CS, Browne K, Fergusson D, Webb E, Janson S. Child maltreatment 1 burden and consequences of child maltreatment in high-income countries. Lancet. 2009;373(9657):68–81. doi: 10.1016/S0140-6736(08)61706-7. - DOI - PubMed
    1. Norman RE, Byambaa M, De R, Butchart A, Scott J, Vos T. The long-term health consequences of child physical abuse, emotional abuse, and neglect: a systematic review and meta-analysis. PLoS Med. 2012;9(11). - PMC - PubMed

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