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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Complex Post-Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Enhanced Skills Training in Affective and Interpersonal Regulation
* Behavioral: Treatment as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly allocated to the intervention arm (ESTAIR) or the control arm (TAU)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESTAIR<br>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). | Behavioral: Enhanced Skills Training in Affective and Interpersonal Regulation<br>* 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.<br>|
| Active Comparator: Treatment as usual (TAU)<br>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. | Behavioral: Treatment as usual<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention rate at the end of treatment | Percentage of clients completing intervention and completing outcome measures at the end of treatment. | Post-treatment (week 25) | 
| Retention rate at 3-months follow up | Percentage of clients completing intervention and completing outcome measures at 3-months follow up. | 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 | The ITQ (Cloitre et al., 2018) is a validated questionnaire assessing PTSD and complex-PTSD (CPTSD). Six items represent the three clusters of PTSD (re-experiencing, avoidance and sense of threat), while another six items represent the three clusters reflecting disturbances in self-organisation (DSO) (AD: affective dysregulation; NSC: negative self-concept; and DR: disturbances in relationships. The remaining items assess functional impairment relating to symptoms of PTSD (3 items) and DSO (3 items). Items are scored using 5-point Likert scales ranging from 0 (not at all) to 4 (extremely), indicating how much a symptom has affected them in the past month. A diagnosis of CPTSD required a diagnosis of PTSD (at least one symptom of each of its three clusters as well as functional impairment) in addition to endorsement of at least one symptom of each of the three DSO clusters plus functional impairment. | Baseline, end of treatment (week 25) and 3-months follow up (week 37) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in symptoms of depression on the 9-item Patient Health Questionnaire (PHQ-9) from baseline to end of treatment to 3-months follow up | The PHQ-9 (Korienke et al., 2001) is a 9-item questionnaire of depression. Items are scored using 4-point Likert scales ranging from 0 (not at all) to 3 (nearly every day), indicating how much they have been bothered by a symptom over the past two weeks. Total scores range from 0 to 27, with higher scores indicating greater levels of depression. Cut-off scores of 15 are used to identify participants likely meeting criteria for depressive disorder. | Baseline, end of treatment (week 25) and 3-months follow up (week 37) | 
| Change in symptoms of generalised anxiety on the 7-item Generalised Anxiety Disorder Questionnaire (GAD-7) from baseline to end of treatment to 3-months follow up | The GAD-7 (Spitzer et al., 2006) is a 7-item questionnaire of generalised anxiety. Items are scored using 4-point Likert scales ranging from 0 (not at all) to 3 (nearly every day), indicating how much they have been bothered by a symptom over the past two weeks. Total scores range from 0 to 21, with higher scores indicating greater levels of anxiety. Cut-off scores of 10 are used to identify participants likely meeting criteria for generalised anxiety disorder. | Baseline, end of treatment (week 25) and 3-months follow up (week 37) | 
| Change in alcohol use on the 3-item (AUDIT-C) from baseline to end of treatment to 3-months follow up | The AUDIT-C (Saunders et al., 1993) consists of the first three items of the Alcohol Use Disorders Identification Test. Items are scored using a 4-point Likert scale. Total scores range from 0 to 12. Based on a nationally representative sample of adults from the United States, scores ≥ 4 effectively capture a diagnosis of Alcohol Use Disorder (AUD). | Baseline, end of treatment (week 25) and 3-months follow up (week 37) | 
| Change in medically unexplained symptoms on the 15-item Patient Health Questionnaire-15 (PHQ-15) from baseline to end of treatment treatment to 3-months follow up | The PHQ-15 (Korienke et al., 2002) is a 15-item questionnaire of somatisation disorder symptoms. Items are scored using 4-point Likert scales ranging from 0 (not bothered at all) to 3 (bothered a little or nearly every day), indicating how much they have been bothered by a symptom over the past two weeks. Total scores range from 0 to 30, with scores of of ≥5, ≥10, ≥15 representing mild, moderate and severe levels of somatization. | Baseline, end of treatment (week 25) and 3-months follow up (week 37) | 
| Outcome on the single item Friends and Family Test (FFT) at end of treatment. | The FFT is a single item assessing the acceptability of an intervention (i.e., ' How likely is it that you would recommend our service to your GP, family and friends if they needed similar care?'). The item is scores on a 5-point Likert scale ranging from 1 (extremely unlikely) to 5 (extremely likely. The FFT is standardly administered as an end-of-treatment measure at Combat Stress | End of treatment (week 25) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CPTSD, ESTAIR, modular therapy