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

OurRelationship 的临床试验，针对退伍军人夫妇的可扩展数字干预措施

• 批准号: 10410254
• 负责人: Kayla Knopp
• 金额: --
• 依托单位: VA SAN DIEGO HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-01 至 2027-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10410254
• 关键词: Address; Anxiety; Area; Award; Behavior; Behavioral; Caring; Clinic; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Communication; Communities; Competence; Conflict (Psychology); Couples; Couples Therapy; Data; Development; Development Plans; Distress; Divorce; Face; Family; Feedback; Feeling suicidal; Goals; Health; Health Care Research; Health Services Accessibility; Health Technology; Healthcare Systems; Hour; Impairment; Individual; Intervention; Interview; K-Series Research Career Programs; Knowledge; Laws; Location; Logistics; Mediation; Medical center; Mental Depression; Mental Health; Mental Health Services; Mentors; Mentorship; Methodology; Methods; Mission; Modeling; Outcome; Participant; Problem Solving; Protocols documentation; Provider; Psychology; Psychotherapy; Quality of life; Randomized Controlled Clinical Trials; Recovery; Rehabilitation Outcome; Rehabilitation therapy; Reporting; Research; Research Personnel; Risk; Role; Sampling; Schedule; Social Functioning; Social Work; Strategic Planning; Stress; Structure; Suicide attempt; System; Technology; Testing; Therapeutic; Time; Training; Trauma; United States Department of Veterans Affairs; Veterans; Waiting Lists; Work; acceptability and feasibility; base; behavioral health; biopsychosocial; cardiovascular risk factor; career; career development; clinically significant; digital; digital health; digital healthcare; digital intervention; efficacy evaluation; evidence base; experience; flexibility; follow-up; functional disability; functional outcomes; health assessment; health care availability; improved; intimate partner violence; medical specialties; military veteran; mortality; online intervention; physical conditioning; pilot test; post intervention; primary outcome; programs; psychiatric symptom; recruit; resilience; satisfaction; secondary analysis; skills; social; social stigma; stressor; system-level barriers; telehealth; theories

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.

背景：超过75%接受行为健康评估的退伍军人认可重要关系 性问题关系困扰导致广泛的健康和心理健康问题，而健康 亲密关系是复原力和康复的生物心理社会模式的重要组成部分。 改善社会功能是RR&D的优先事项，VHA指令1163.04要求所有退伍军人 获得灵活的家庭心理健康服务。然而，获得夫妇的干预是 有限：受过训练的夫妻治疗师在数量和地点上都有限，而且由于后勤问题，他们没有得到充分利用。 夫妇面临的障碍包括协调时间表、双休、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，退伍军人花了四个， 在寻求帮助之前陷入了七年的感情困境数字健康是解决健康问题的关键部分。 获得护理。夫妇的数字干预措施提供了灵活的循证关系 干预措施，并为提供可扩展的家庭精神卫生保健至关重要。我们的关系是 一个基于证据的夫妇疗法（整合行为夫妇疗法）的在线改编， 结合了8个小时的自定进度的在线夫妻计划和3个20分钟的远程健康指导， sessions.几项随机对照试验表明，OurRelationship改善了关系功能和个人心理健康， 包括社区招募的退伍军人。我们的试验数据来自13对夫妇， 弗吉尼亚州圣地亚哥表明退伍军人发现我们的关系有吸引力和帮助。然而，我们的关系 尚未在VA医疗中心环境中对退伍军人人群进行严格评估。 方法：拟议的5年研究是一项为期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扰的退伍军人及其伴侣（N = 180）提供服务，招募 来自VASDHS内的个人和家庭心理健康诊所。康复结果数据，包括 关系功能（主要结果），关系行为（例如，沟通，冲突），个人 功能（例如，功能性残疾、家庭角色）和精神症状（例如，抑郁症，焦虑症） 在基线、项目中期、项目后和6个月随访时收集。我们将收集参与者的反馈 通过定性访谈和治疗联盟和计划满意度的定量评级。 目的：目的1是检查在VA环境中实施OurRelationship的可行性和可接受性， 退伍军人和他们的伙伴。目的2是评估OurRelationship计划在改善 为退伍军人和他们的合作伙伴提供服务。目标3是探索改善 通过改善关系功能来实现个人功能成果。 职业发展计划：这个指导职业发展奖将支持博士。 独立的临床研究人员和数字健康和夫妇干预作用的专家， 在VA系统内进行康复。通过莱斯利·莫兰博士的指导和莱斯利·莫兰博士的共同指导。 科林·德普，雪莉·格林博士和布赖恩·多斯博士，这个CDA-2培训计划建立在克诺普博士的临床和 在亲密关系的研究背景，以提高她1）在临床试验设计的能力， 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， 以及4）专业发展为VA康复临床研究者。这次培训会让克诺普医生 通过提交VA RR&D Merit Award申请继续这项研究计划，重点是提供 数字夫妇的干预措施，以最大限度地提高个人心理健康治疗的效益。