Multisite RCT of STEP-Home: A Transdiagnostic Skill-based Community Reintegration Workshop
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 2
- 主要终点
- Military to Civilian Questionnaire
研究概览
简要总结
In this proposal, the investigators extend their previous SPiRE feasibility and preliminary effectiveness study to examine STEP-Home efficacy in a RCT design. This novel therapy will target the specific needs of a broad range of underserved post-9/11 Veterans. It is designed to foster reintegration by facilitating meaningful improvement in the functional skills most central to community participation: emotional regulation (ER), problem solving (PS), and attention functioning (AT). The skills trained in the STEP-Home workshop are novel in their collective use and have not been systematically applied to a Veteran population prior to the investigators' SPiRE study. STEP-Home will equip Veterans with skills to improve daily function, reduce anger and irritability, and assist reintegration to civilian life through return to work, family, and community, while simultaneously providing psychoeducation to promote future engagement in VA care.
The innovative nature of the STEP-Home intervention is founded in the fact that it is: (a) an adaptation of an established and efficacious intervention, now applied to post-9/11 Veterans; (b) nonstigmatizing (not "therapy" but a "skills workshop" to boost acceptance, adherence and retention); (c) transdiagnostic (open to all post-9/11 Veterans with self-reported reintegration difficulties; Veterans often have multiple mental health diagnoses, but it is not required for enrollment); (d) integrative (focus on the whole person rather than specific and often stigmatizing mental and physical health conditions); (e) comprised of Veteran-specific content to teach participants cognitive behavioral skills needed for successful reintegration (which led to greater acceptability in feasibility study); (f) targets anger and irritability, particularly during interactions with civilians; (g) emphasizes psychoeducation (including other available treatment options for common mental health conditions); and (h) challenges beliefs/barriers to mental health care to increase openness to future treatment and greater mental health treatment utilization. Many Veterans who participated in the development phases of this workshop have gone on to trauma or other focused therapies, or taken on vocational (work/school/volunteer) roles after STEP-Home.
The investigators have demonstrated that the STEP-Home workshop is feasible and results in pre-post change in core skill acquisition that the investigators demonstrated to be directly associated with post-workshop improvement in reintegration status in their SPiRE study. Given the many comorbidities of this cohort, the innovative treatment addresses multiple aspects of mental health, cognitive, and emotional function simultaneously and bolsters reintegration in a short-term group to maximize cost-effectiveness while maintaining quality of care.
详细描述
Post-9/11 Veterans who served in OEF/OIF face many challenges as they re-enter civilian life after structured military careers. Yet, underutilization and resistance to mental health treatment remains a significant problem. Recent investigations of community reintegration problems among returning Veterans found that half of combat Veterans who use Veterans Administration (VA) services reported difficulty in readjusting to civilian life, including difficulty in social functioning, productivity in work and school settings, community involvement, and self-care domains. High rates of marital, family, and cohabitation discord were reported, with 75% reporting a family conflict in the last week. At least one-third reported divorce, dangerous driving and risky behaviors, increased substance use, and impulsivity and anger control problems since deployment. Almost all Veterans expressed interest in receiving services to help readjust to civilian life, and receiving reintegration services at a VA facility was reported as the preferred way to receive help. Mental health and anger problems are often cited as driving Veterans' difficulties readjusting to civilian life. Anger is becoming more widely recognized for its involvement in the psychological adjustment problems of post-9/11 Veterans. Research has shown that anger directly influences treatment outcome. In fact, history of untreated PTSD and aggression have been demonstrated to be pervasive among post-9/11 Veterans who die by suicide in the months before death. Veterans with probable PTSD report more reintegration and anger problems, and greater interest in services than Veterans without. Reintegration and anger problems continue for years post-combat and may not resolve without intervention.
Research on TBI in post-9/11 Veterans underscores the need for programs that utilize an interdisciplinary approach to reintegration. Programs designed to address challenges of Veterans as they reintegrate in vocational environments, particularly integrative approaches, are greatly needed. The STEP-Home intervention provides such a program. STEP-Home includes focused cognitive and emotional regulation skills training and is informed by the most recent research with returning Veterans and available programs focused on reintegration in VA and military settings (e.g., Battlemind training).
Phase 1: Years 1 and 2 The investigators will initiate the study at the Boston VAMC and develop Standard Operating Procedures for the addition of site 2 in Phase 2.
Phase 2: Years 3 and 4 The investigators will initiate the study at the second site, the Houston VAMC, in Year 3. The investigators will apply in Year 2 for IRB approval to initiate site 2.
Hypotheses & Aims
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 (Participant)
盲法说明
Assessments are all self-report, therefore, blinded assessors are not required.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Post-9/11 Veterans who report some reintegration, readjustment, or anger difficulty
- •i.e., Veterans who report "some difficulty" (Likert rating) on at least one of the primary measures: M2CQ; PDRI; STAXI-2
- •18-75 years old (to avoid outcomes being affected by aging)
- •English-speaking (sessions will be conducted in English)
- •Agreeing to participate
- •i.e., completion of ICF/HIPAA
排除标准
- •schizophreniform disorder/active psychosis
- •bipolar disorder
- •active suicidality/homicidality requiring crisis intervention
- •other severe psychiatric disorders prohibiting appropriate group participation
- •neurological diagnosis prohibiting appropriate group participation (excluding TBI)
- •current substance dependence
- •current participation in any other form of active behavioral therapy at the time of enrollment
- •e.g., Cognitive Processing Therapy, cognitive rehabilitation for mTBI, or other psychotherapy
研究组 & 干预措施
STEP-Home
The STEP-Home Arm involves a skills-based intervention focused on Emotional Regulation, Problem Solving, and Attention Training strategies.
干预措施: STEP-Home (Behavioral)
PCGT
The Present Center Group Therapy (PCGT) Arm involves a nonspecific, supportive intervention, focused on identifying and discussing current life stressors.
干预措施: PCGT (Behavioral)
结局指标
主要结局
Military to Civilian Questionnaire
时间窗: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
A 16-item measure of post-deployment community reintegration in post-9/11 Veterans. Higher scores indicate greater reintegration and functional difficulties. Min: 0, Max: 64
Post-deployment Readjustment Inventory (Change)
时间窗: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
A 36-item measure of readjustment in post-9/11 Veterans with six subscales (career challenges, social difficulties, intimate relationship problems, health concerns, concerns about deployment, and PTSD symptoms). Min and max scores for all the subscales, and the total score, are below. For all, lower scores are better. Total score is calculated by adding the value of all items in all subscales. Career: Min: 5, Max: 25 Health: Min: 5, Max: 25 Intimate Relationship: Min: 5, Max: 25 Social readjustment: Min: 7, Max: 35 Concerns about deployment: Min: 6, Max: 30 PTSD symptoms: Min: 8, Max: 40 TOTAL score: Min: 36, Max: 180
State-Trait Anger Expression Inventory (STAXI-2) (Change)
时间窗: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
A 57-item widely used measure to assess state anger, trait anger, and anger expression with three subscales (state anger, trait anger, and anger expression). Min and max scores for the subscales, and the total score, are below. For all, lower scores are better. How I Feel Right Now (State Anger): Min: 10, Max: 40, Calculated by summing 15 items in scale How I Generally Feel (Trait Anger): Min: 10, Max: 40, Calculated by summing 15 items in scale When Angry or Furious (Anger expression index): Min: 24, Max: 96, Calculated by summing anger control scores for each item (12 items) and subtracting that from sum of anger expression scores for each item (12 items)
次要结局
- Attention-Related Cognitive Errors Scale (ARCES) (Change)(Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up))
- Problem Solving Inventory (PSI) (Change)(Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up))
- Difficulties in Emotion Regulation Scale (DERS) (Change)(Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up))
- PTSD Checklist for DSM-5 (PCL-5) (Change)(Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up))
- Depression Anxiety and Stress Scale (DASS-21) (Change)(Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up))
- Neurobehavioral Symptoms Inventory (NSI) (Change)(Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up))
- World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change)(Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up))
- Satisfaction With Life Scale (SWLS) (Change)(Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up))
- Number of Participants Differing in Activity Engagement Over Time (Change)(Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up))
- Barriers to Employment Success Inventory (BESI) (Change)(Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up))
- Number of Participants Differing in Average Number of Hours Worked (Change)(Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up))
- Frontal Systems Behavior Scale (FrSBe) (Change)(Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up))