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

Combat Stress

Status: Unknown

Conditions: Complex Post-Traumatic Stress Disorder

Treatments: Behavioral: Treatment as usual; Behavioral: Enhanced Skills Training in Affective and Interpersonal Regulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04752072

FiMT19/0429EDU (Other Grant/Funding Number)

SHSC2686062

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

ESTAIR

Experimental group

Description:

ESTAIR (Cloitre et al., 2019) will consist of up to 25 sessions, organized in 4 modules of 6 sessions targeting symptoms of PTSD and disturbances in self-organisation (AD: affective dysregulation; NSC: negative self-concept; and DR: disturbances in relationships).

Treatment:

Behavioral: Enhanced Skills Training in Affective and Interpersonal Regulation

Treatment as usual (TAU)

Active Comparator group

Description:

At present, there are no recommended treatments for CPTSD. TAU will consist of a treatment package that could include elements of psychoeducation, symptom-management and trauma-focused cognitive behaviour therapy, resembling established protocols for treating PTSD.

Treatment:

Behavioral: Treatment as usual