RESTORE Trial: A Pilot RCT of Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR) for Veterans With CPTSD
- Conditions
- Complex Post-Traumatic Stress Disorder
- Interventions
- Behavioral: Treatment as usualBehavioral: Enhanced Skills Training in Affective and Interpersonal Regulation
- Registration Number
- NCT04752072
- Lead Sponsor
- Combat Stress
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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
- Severe psychotic disorder (defined by previous clinical diagnosis)
- Current alcohol or drug use disorder
- Serious cognitive impairment
- Planned concurrent additional treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment as usual (TAU) Treatment as usual 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. ESTAIR Enhanced Skills Training in Affective and Interpersonal Regulation 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).
- Primary Outcome Measures
Name Time Method Retention rate at 3-months follow up 3-months follow-up (week 37) Percentage of clients completing intervention and completing outcome measures at 3-months follow up.
Change in symptoms of CPTSD on the International Trauma Questionnaire (ITQ) from baseline to end of treatment to 3-months follow up Baseline, end of treatment (week 25) and 3-months follow up (week 37) 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.Retention rate at the end of treatment Post-treatment (week 25) Percentage of clients completing intervention and completing outcome measures at the end of treatment.
- Secondary Outcome Measures
Name Time Method 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 Baseline, end of treatment (week 25) and 3-months follow up (week 37) 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.Outcome on the single item Friends and Family Test (FFT) at end of treatment. End of treatment (week 25) 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
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 Baseline, end of treatment (week 25) and 3-months follow up (week 37) 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.
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 Baseline, end of treatment (week 25) and 3-months follow up (week 37) 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.
Change in alcohol use on the 3-item (AUDIT-C) from baseline to end of treatment to 3-months follow up Baseline, end of treatment (week 25) and 3-months follow up (week 37) 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).
Trial Locations
- Locations (1)
Combat Stress
🇬🇧Leatherhead, Surrey, United Kingdom