Clinical Trial of OurRelationship, a Scalable Digital Intervention for Veteran Couples

背景：在接受行为健康评估的退伍军人中，超过75%的人认可 担忧。感情困扰会导致一系列的健康和心理健康问题，而健康的 亲密关系是复原力和康复的生物心理社会模型的重要组成部分。 改善社会功能是RR&D的优先事项，而退伍军人管理局指令1163.04要求所有退伍军人 获得灵活的连续的家庭心理健康服务。然而，获得夫妇干预的机会是 有限：受过培训的夫妻治疗师在数量和地点上都是有限的，而且由于后勤方面的原因，他们的利用率很低 夫妻面临的障碍包括协调时间表、双重休假、育儿和耻辱。因为. 这些障碍，超过60%的离婚夫妇从未获得夫妇的治疗，退伍军人花费4到 在寻求帮助之前，她经历了七年的感情困境。数字健康是解决以下问题的关键部分 获得护理的途径。为夫妻提供的数字干预提供了灵活的循证关系途径 干预措施，对于提供可扩展的家庭心理保健服务至关重要。我们的关系是 循证夫妻疗法(整合型行为夫妻疗法)的在线改编， 将8小时的自我调整的在线夫妻计划与3个20分钟的远程健康辅导结合在一起 会话。一些随机对照试验表明，我们的关系改善了人际关系功能和个人心理健康。 包括社区招募的退伍军人。我们的试点数据来自13对夫妇在两个月的时间里招募的 弗吉尼亚州圣地亚哥表示，退伍军人发现我们的关系很有吸引力，也很有帮助。然而，我们的关系已经 尚未在退伍军人医疗中心与退伍军人进行严格评估。 研究方法：这项为期5年的研究是一项为期2个月的等待名单对照随机临床试验。我们的目标是 为90名有心理健康问题和关系困难的退伍军人及其伴侣(N=180)提供服务，招募 来自VASDHS的个人和家庭心理健康诊所。关于康复结果的数据包括 关系运作(主要结果)、关系行为(例如，沟通、冲突)、个人 功能(例如，功能残疾、家庭角色)和精神症状(例如，抑郁、焦虑) 在基线、计划中期、计划后和6个月的随访时收集数据。我们将收集参与者的反馈 通过定性访谈和对治疗联盟和计划满意度的定量评级。 目标：目标1是检查在退伍军人管理局环境下实施关系的可行性和可接受性 退伍军人和他们的伙伴。目标2是评估OurRelationship计划在改善 为退伍军人及其伴侣发挥作用的关系。目标3是探索调解改善 通过改善关系功能而产生的个人功能结果。 职业发展计划：这个指导职业发展奖将支持克诺普博士成为一名 独立临床研究员和数字健康和夫妇干预在 退伍军人制度内的康复。通过莱斯利·莫兰德博士的指导和莱斯利·莫兰德博士的共同指导。 科林·德普、雪莉·格林博士和布莱恩·多斯博士，这项CDA-2培训计划建立在克诺普博士的临床和 在亲密关系方面的研究背景，以提高她1)临床试验设计和 分析，2)数字医疗技术和研究的知识，3)纵向二元试验数据的技能， 4)作为VA康复临床研究人员的专业发展。这次培训将为克诺普博士做好准备 通过提交VA RR&D荣誉奖申请来继续此研究计划，重点是 辅助性数字夫妇干预，最大限度地提高个体心理健康治疗的效益。

Background: Over 75% of Veterans referred for behavioral health assessments endorse significant relationship concerns. Relationship distress leads to a wide range of health and mental health problems, whereas healthy intimate relationships are an important part of biopsychosocial models of resilience and rehabilitation. Improving social functioning is an RR&D priority, and VHA directive 1163.04 mandates all Veterans have access to a flexible continuum of family mental health services. However, access to couples’ interventions is limited: trained couple therapists are limited in number and location, and they are underutilized due to logistical barriers couples face including coordinating schedules, dual time off work, childcare, and stigma. Because of these barriers, over 60% of divorced couples never accessed couples’ treatment, and Veterans spend four to seven years in relationship distress before getting help. Digital health is a critical part of solving problems of access to care. Digital interventions for couples provide flexible access to evidence-based relationship interventions and are essential for providing scalable access to family mental health care. OurRelationship is an online adaptation of an evidence-based couple therapy (Integrative Behavioral Couple Therapy), which combines eight hours of a self-paced online couples’ program with three 20-minute telehealth coaching sessions. Several RCTs show OurRelationship improves relationship functioning and individual mental health, including among community-recruited Veterans. Our pilot data from 13 couples recruited over two months in VA San Diego indicate Veterans find OurRelationship appealing and helpful. However, OurRelationship has not yet been rigorously evaluated with a Veteran population in a VA medical center setting. Methodology: The proposed 5-year study is a 2-month waitlist-controlled randomized clinical trial. We aim to serve 90 Veterans with mental health concerns and relationship distress and their partners (N = 180), recruited from individual and family mental health clinics within VASDHS. Data on rehabilitation outcomes including relationship functioning (primary outcome), relationship behaviors (e.g., communication, conflict), individual functioning (e.g., functional disability, family role), and psychiatric symptoms (e.g., depression, anxiety) will be collected at baseline, mid-program, post-program, and 6-month follow-up. We will collect participant feedback via qualitative interviews and quantitative ratings of therapeutic alliance and program satisfaction. Aims: Aim 1 is to examine feasibility and acceptability of implementing OurRelationship in a VA setting with Veterans and their partners. Aim 2 is to evaluate efficacy of the OurRelationship program on improving relationship functioning for Veterans and their partners. Aim 3 is to explore mediation of improvements in individual functional outcomes by improvements in relationship functioning. Career Development Plan: This mentored career development award will support Dr. Knopp in becoming an independent clinical researcher and an expert in the role of digital health and couples’ interventions in rehabilitation within the VA system. Through mentorship from Dr. Leslie Morland and co-mentorship from Dr. Colin Depp, Dr. Shirley Glynn, and Dr. Brian Doss, this CDA-2 training plan builds on Dr. Knopp’s clinical and research background in intimate relationships to enhance her 1) competence in clinical trial design and analysis, 2) knowledge of digital healthcare technology and research, 3) skills in longitudinal dyadic trial data, and 4) professional development as a VA rehabilitation clinical researcher. This training will prepare Dr. Knopp to continue this program of research by submitting a VA RR&D Merit award application focused on providing adjunctive digital couples’ interventions to maximize benefit of individual mental health treatments.