Developing an Online Therapeutic Intervention for Chronic Pain in Veterans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- System Usability Scale (SUS)
研究概览
简要总结
Chronic pain is a serious concern that disproportionately affects Veterans compared to the general public; Veterans are diagnosed with chronic pain at particularly high rates (47 - 56%) with a 40% greater rate of severe pain than non-Veterans. Veterans with chronic pain face numerous negative functional outcomes, including decreased ability to complete daily work activities, less social support from and closeness with family members, increased chronic health conditions (e.g., cancer, heart disease), and higher mortality compared to Veterans without chronic pain. Given these concerns, there is an urgent need for innovative and integrative approaches for non-medical pain self-management management. Despite the critical importance of effective pain self-management programs, many Veterans with chronic pain do not engage in pain self-management programs. In order to improve Veterans' quality of life, it is important to develop and evaluate innovative, accessible, evidence-based interventions for managing chronic pain.
One approach with over twenty years of efficacious treatment for chronic pain is Acceptance and Commitment Therapy (ACT) for Chronic Pain (ACT-CP). ACT is a well-established VA-approved approach to chronic pain management, and focuses on committing to behavior change that reflects personal values, leading to significant improvement in life functioning. ACT- CP is associated with substantial improvements in social/work functioning and decreased pain-related medical visits, as long as three years following treatment. For adults with chronic pain, technology-assisted ACT treatment leads to reduced self-reported pain levels and improved health via changes in value-aligned behaviors and mindfulness. The use of interactive technology-assisted ACT treatment is acceptable and efficacious; however, no ACT for chronic pain online treatment exists for Veterans.
The investigators will thus complete a three-phase development, intervention usability and feasibility, and randomized controlled trial (RCT) pilot to create Veteran ACT intervention for chronic pain (VACT-CP). VACT-CP will utilize a personalized, social interface to address pain-related distress and functional difficulties of chronic pain (e.g., avoidance, reactivity), using an online Embodied Conversational Agent (ECA) that will walk Veterans through eight weeks of treatment. Studies suggest that the use of such ECAs can increase online-treatment motivation and feedback, resulting in increased treatment compliance and utilization, physical functioning (e.g., increased physical activity and diet fidelity), and client-goal achievement. The primary outcomes for this project will be to (1) develop the VACT-CP user system using feedback from mental health and other clinical professionals treating chronic pain (n = 10), (2) pilot the usability and feasibility of the through iterative usability development and Veteran feedback (n = 12 - 15), and (3) explore the impact of the VACT-CP system in terms of user-experience, functional outcome improvement, and quality of life measures (n = 40).
详细描述
The research study for this career development plan involves the development, iterative user testing, and evaluation of an online ACT treatment program for Veterans with chronic pain. This study will determine whether a larger-scale, more definitive VACT-CP full scale efficacy trial is indicated.
Phase 1: Development Phase (15 months): I will develop a detailed VACT-CP protocol for individual online treatment. Treatment techniques will be based on previously-developed ACT treatments for chronic pain, as well as additional ACT training I will obtain during the early phase of the Rehabilitation Research and Development (RR&D) Career Development Award (CDA-2). During this phase, mental health and other clinical staff providing pain care at the Veterans Affairs (VA) Bedford Medical Center (n = 10) will provide feedback and input on the intervention content.
Phase 2: Pilot Evaluation of Intervention Components in Field-Based Iterative Usability Testing (21 months): The investigators will recruit Veterans (n=15) with chronic pain for usability testing, to assess the delivery mode, and utilize an Integrated Technology Acceptance Model to iteratively assess feasibility and usability of the VACT-CP online treatment. This portion of the project will focus on refining the delivery mode, and revising chronic pain intervention content as necessary. With my mentors, I will review the adequacy, utility of specific procedures, and intervention foci to revise the online treatment accordingly.
Phase 3: Feasibility Pilot Randomized Controlled Trial (30 months): The investigators will assess the feasibility and acceptability using a Stage 1b RCT pilot test comparing VACT-CP (n = 20) to a wait-list control group (n = 20), including ease of recruitment, retention in each condition, treatment receptivity, attrition and retention in each condition, sustained participation, and the assessment process. The investigators will also describe preliminary data on the impact of VACT-CP vs. the control condition on pain-related functioning related to social, occupational, and physical functioning, emotional functioning, mental health, and quality of life.
PHASE 1: INTERVENTION DEVELOPMENT
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current diagnosis of non-cancer chronic pain, defined as:
- •at least one pain-related diagnosis indicated by an ICD-9 or -10 code related to either Musculoskeletal pain or Joint Problems/Osteoarthritis
- •or presence of chronic pain of at least mild to moderate severity as indicated by two or more NRS pain scores of 4 at three separate VA outpatient visits in past year based on a CPRS record review;
- •Has a working, high-speed wireless internet connection at home, or is willing to access sessions either at the Bedford VAMC by using a tablet in a secure space
- •Competent to provide written informed consent
排除标准
- •Any current or lifetime DSM-5 psychotic disorder
- •Current or recent (within 1 month of study entry) DSM-5 alcohol or drug use disorder
- •[Current use of any other chronic pain-related behavioral or psychological treatment]
- •Any cognitive impairment that would interfere with study participation
- •Clinically significant suicidality within the past year
- •Presence of any clinical features requiring a higher level of care (inpatient or partial hospital treatment)
- •Any cognitive or physical impairment that would interfere with study participation of using a tablet/computer and providing feedback
研究组 & 干预措施
Waitlist Control Group
Veterans in the waitlist control will be provided with a list of common pain resources at the Bedford VAMC.
VACT-CP Group
Veterans randomized to VACT-CP will receive 7 online-module based weekly sessions of treatment via personal computer or provided tablet with wireless accessibility at the Bedford VAMC.
干预措施: Veteran Acceptance and Commitment Therapy for Chronic Pain (Behavioral)
结局指标
主要结局
System Usability Scale (SUS)
时间窗: Post-Intervention, at 8 weeks for VACT-CP group only
The SUS is a 10-item measure, scored on a 5-point Likert scale from Strongly Disagree (1) to Strongly Agree (5), that assesses human-computer interaction. The SUS generates a subjective evaluation score using a globally accepted scale and to understand if the system in its current form is sufficiently usable. To calculate the SUS score, first sum the score contributions from each item. Each item's score contribution will range from 0 to 4. For items 1,3,5,7,and 9 the score contribution is the scale position minus 1. For items 2, 4, 6, 8, and 10, the contribution is 5 minus the scale position. Multiply the sum of the scores by 2.5 to obtain the overall value of system usability. SUS scores have a range of 0 to 100, with higher scores suggesting greater system usability. A SUS score above 58 is regarded as above average, and a SUS score above 80 is regarded as high and a score above which participants are likely to recommend the product to friends.
Usability Survey
时间窗: Through study completion (pre and post), on average 8 weeks
The usability survey items are drawn from a questionnaire developed by Wilson and Lankton (2004) to measure a range of health information technology areas. Each item is scored on a 5 point Likert scale where 1 = strongly disagree and 5 = strongly agree, with an average calculated for each scale ranging from 1 to 5. For the current study, 3 subscales were used: Intrinsic Motivation Scale, Perceived Ease of Use Scale, and Perceived Usefulness: For each scale respectively, higher scores indicating greater levels of motivation, perceived ease of use, and perceived usefulness.
次要结局
- Pain Outcomes Questionnaire - VA (POQ - VA)(Through study completion (pre and post), on average 8 weeks)
- The Chronic Pain Acceptance Questionnaire (CPAQ)(Through study completion (pre and post), on average 8 weeks)
- Multidimensional Experiential Avoidance Questionnaire (MEAQ)(Through study completion (pre and post), on average 8 weeks)
- The Chronic Pain Values Inventory (CPVI)(Through study completion (pre and post), on average 8 weeks)
- Pain Numeric Rating Scale(Through study completion (pre and post), on average 8 weeks)
- Client Satisfaction Questionnaire-8 (CSQ-8)(Post-intervention measure (average 8 weeks after baseline))