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
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Retention rate at 3-months follow up
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
It was initially intended for the research assistant collecting post-intervention and follow-up outcome measures to be masked to arm allocation. However, it is noted that such masking is not feasible. This is not deemed a risk to the study as outcome measures are self-report measures.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Severe psychotic disorder (defined by previous clinical diagnosis)
- •Current alcohol or drug use disorder
- •Serious cognitive impairment
- •Planned concurrent additional treatment
结局指标
主要结局
Retention rate at 3-months follow up
时间窗: 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
时间窗: 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
时间窗: Post-treatment (week 25)
Percentage of clients completing intervention and completing outcome measures at the end of treatment.
次要结局
- 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))
- Outcome on the single item Friends and Family Test (FFT) at end of treatment.(End of treatment (week 25))
- 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))
- 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))
- 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))
研究者
Prof. Dominic Murphy
Head of research department
Combat Stress