NCT04752072

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

RESTORE Trial: A Pilot RCT of Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR) vs. Treatment as Usual (TAU) for Complex Posttraumatic Stress Disorder (CPTSD) in Military Personnel

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Combat Stress · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Complex Post-Traumatic Stress Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Enhanced Skills Training in Affective and Interpersonal Regulation	The first (formulation) session enables linking present difficulties and traumatic events, identifying current issues/concerns, and collaboratively agreeing on the order of modules based on symptom severity and client readiness. The PTSD module provides narrative exposure to the traumatic memories and targets re-experiencing, avoidance and hyperarousal symptoms. The AD module focuses on identifying and labelling feelings, emotion management, distress tolerance, acceptance of feelings and experiencing positive emotions. The NSC module focuses on staying in the present moment and combating dissociation; self-compassion and mindfulness skills; challenging thinking patterns and developing a balanced view of self. The DR module focuses on exploring and revising maladaptive schemas; effective assertiveness; awareness of social context; and flexibility in interpersonal expectations and behaviours displayed in social interactions.
BEHAVIORAL	Treatment as usual	The first session will involve a mental health assessment by either a psychiatrist or psychologist. A treatment package will be developed based on the information collected during the assessment. Details of the interventions delivered to each participant receiving TAU, which will include elements of psychoeducation, symptom-management and trauma-focused cognitive behaviour therapy, will be recorded.

Timeline

• Start date: 2021-02-25
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2021-02-12
• Last updated: 2022-04-29

Locations

1 site across 1 country: United Kingdom