Enhanced Skills Training in Affective and Interpersonal Regulation versus Treatment as Usual for ICD-11 Complex PTSD: A Pilot Randomised Controlled Trial (The RESTORE Trial)

Thanos Karatzias; Mark Shevlin; Marylène Cloitre; Walter Busuttil; Katherine Graham; Laura Hendrikx; Philip Hyland; Natasha Biscoe; Dominic Murphy

doi:10.1159/000538428

Enhanced Skills Training in Affective and Interpersonal Regulation versus Treatment as Usual for ICD-11 Complex PTSD: A Pilot Randomised Controlled Trial (The RESTORE Trial)

Psychother Psychosom. 2024 Apr 30:1-13. doi: 10.1159/000538428. Online ahead of print.

Authors

Thanos Karatzias^{1

2}, Mark Shevlin³, Marylène Cloitre^{4

5}, Walter Busuttil⁶, Katherine Graham⁶, Laura Hendrikx⁶, Philip Hyland⁷, Natasha Biscoe⁶, Dominic Murphy^{4

8}

Affiliations

¹ School of Health and Social Care, Edinburgh Napier University, Edinburgh, UK.
² NHS Lothian Rivers Centre for Traumatic Stress, Edinburgh, UK.
³ School of Psychology, Ulster University, Northern Ireland, UK.
⁴ National Center for PTSD Dissemination and Training Division, VA Palo Alto Health Care System, Palo Alto, California, USA.
⁵ Department of Psychiatry and Behavioural Sciences, Stanford University, Stanford, California, USA.
⁶ Research Department, Combat Stress, Surrey, UK.
⁷ Department of Psychology, Maynooth University, Kildare, Ireland.
⁸ King's Centre for Military Research, Kings College London, London, UK.

PMID: 38688242
DOI: 10.1159/000538428

Abstract

Introduction: Complex PTSD (CPTSD) is a relatively new condition in ICD-11. This pilot randomised controlled trial aimed to compare a four-module intervention developed to target all symptoms of ICD-11 CPTSD, namely Enhanced Skills in Affective and Interpersonal Regulation (ESTAIR) with treatment as usual (TAU). The purpose of the study was to assess feasibility, safety, acceptability, and preliminary outcomes at the end of treatment and 3-month follow-up.

Methods: A total of N = 56 eligible veterans with CPTSD were randomised to either ESTAIR (n = 28) or TAU (n = 28). Linear mixed models were conducted to assess CPTSD severity, the primary outcome, as measured by the International Trauma Questionnaire (ITQ).

Results: Treatment dropout in ESTAIR and TAU was low and equivalent (18% vs. 11%; χ2 (1) = 1.19, p = 0.275), and study retention was high, supporting the feasibility of the study. No serious adverse effects and very few adverse effects occurred, none of which were deemed related to the study. ESTAIR provided significantly greater reduction in CPTSD severity across time for ITQ PTSD (p < 0.001) and DSO (p < 0.001) symptoms. CPTSD pre-to-post effect sizes for ESTAIR were large (PTSD d = 1.78; DSO d = 2.00). Remission of probable CPTSD diagnosis at post-treatment was substantially greater in ESTAIR compared to TAU with only 13.6% versus 84% (p < 0.001) retaining the diagnosis.

Conclusion: A trial of ESTAIR versus TAU for the treatment of ICD-11 CPTSD indicates the potential efficacy of ESTAIR as well as its feasibility, safety, and acceptability.

Keywords: Complex PTSD; Estair; RCT.