UnknownNot Applicable

RESTORE Trial: A Pilot RCT of Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR) for Veterans With CPTSD

United Kingdom60 participantsStarted 2021-02-25

Plain-language summary

Complex Post traumatic Stress Disorder (CPTSD) is now recognized as a separate trauma-based psychological condition to PTSD. CPTSD is a broader diagnosis that includes the core PTSD symptoms (re-experiencing in the here and now, avoidance, and sense of current threat) plus an additional set of symptoms that are collectively referred to as 'disturbances in self-organisation' (DSO). DSO symptoms capture pervasive psychological disturbances that are associated with traumatic exposures and that are distributed across three clusters: difficulties in affect regulation (AR), negative self-concept (NSC), and disturbances in relationships (DR). There are no effective interventions for CPTSD. It is therefore of paramount important to identify effective interventions to treat veterans with CPTSD. The present study will be one of the first to investigate the effectiveness of a novel, modular intervention for CPTSD. Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR) is a person-centered intervention that involves targeting the symptoms of CPTSD clusters sequentially using concrete modules (i.e., specific number of sessions targeting specific clusters of symptoms). The overall aim of this study is to establish the feasibility, acceptability and preliminary effects of ESTAIR in treating CPTSD. To achieve these aims, the investigators will conduct a pilot randomised controlled trial (RCT), with a sample of 60 military veterans meeting the diagnostic criteria for CPTSD, and with two treatment arms: ESTAIR vs. a treatment-as-usual (TAU) condition.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Adults (18 years or older) in the caseload of Combat Stress * Armed forces veteran (United Kingdom) * Help-seeking for trauma-related psychological distress * Meeting diagnostic criteria for CPTSD, as measured by the ITQ (Cloitre et al., 2018) * Proficiency in English language * Signed informed consent provided Exclusion Criteria: * Severe psychotic disorder (defined by previous clinical diagnosis) * Current alcohol or drug use disorder * Serious cognitive impairment * Planned concurrent additional treatment

What they're measuring

Retention rate at the end of treatment

Timeframe: Post-treatment (week 25)

Retention rate at 3-months follow up

Timeframe: 3-months follow-up (week 37)

Change in symptoms of CPTSD on the International Trauma Questionnaire (ITQ) from baseline to end of treatment to 3-months follow up

Timeframe: Baseline, end of treatment (week 25) and 3-months follow up (week 37)

Trial details

NCT IDNCT04752072

SponsorCombat Stress

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02

Contact for this trial

Dominic Murphy, Prof.

01372 587 017 dominic.murphy@combatstress.org.uk

View on ClinicalTrials.gov More Complex Post-Traumatic Stress Disorder trials