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临床试验/NCT06058624
NCT06058624招募中不适用

Assessing the Efficacy of an Acceptance-Based Digital Intervention to Improve Functioning for Veterans With Chronic Pain

VA Office of Research and Development3 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年7月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
240
试验地点
3
主要终点
Veteran's RAND 36 Item Health Survey (VR-36) Change

研究概览

简要总结

Pain has been identified as among the most frequent presenting medical complaints, in particular within primary care for Veterans. There are few areas of daily living and functioning that pain intensity does not impact, with reported pain intensity related to difficulties in social situations and changes in activities of daily life, sleep, and appetite. Therapeutic interventions such as Acceptance and Commitment Therapy for Chronic Pain (ACT-CP) that target issues related to the cognitions and emotional concerns related to chronic pain have been well-documented for reduction of associated psychiatric symptoms and modest pain relief. At the same time, online programming can improve the ability of pain psychoeducation programs and ACT-CP to reach patients. The proposed project will compare online Veteran ACT for Chronic Pain (VACT-CP) compared to another pain program, Online Pain School, to evaluate how they assist Veterans with chronic pain to improve their functioning, pain management, and quality of life.

详细描述

Chronic pain is a serious concern that disproportionately affects Veterans compared to the general public; Veterans are diagnosed with CP 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. Unfortunately, the use of medication for long-term pain treatment, though often utilized, has both limited efficacy and potentially harmful outcomes. 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 available through the VA. There are numerous reasons for this, including perceived time and transportation concerns and pain-related barriers to attending in-person care options. To improve Veterans' quality of life and it is important to develop and evaluate innovative, accessible, evidence-based interventions for managing pain that can be easily accessed where healthcare happens most - within the home.

One approach with over twenty years of efficacious treatment for chronic pain is Acceptance and Commitment Therapy for Chronic Pain (ACT-CP). ACT is a well-established and 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. Though provided at many VA hospitals, clinician-delivered ACT for chronic pain has not had a nationwide rollout and is not available at all VA pain clinics. Additionally, many Veterans with chronic pain do not access one-on-one therapeutic treatment due to transportation and time issues. Thankfully, for adults with chronic pain outside of the VA, technology-delivered ACT has been found to be acceptable, useful, and efficacious in delivering pain treatment. However, although research suggests it could help with at-home pain management, no ACT for chronic pain online treatment exists specifically for Veterans and their particular care needs.

To address this treatment option gap, the research team created an online Veteran ACT for chronic pain (VACT-CP) during the PI's Rehabilitation R&D CDA-2 project. VACT-CP is guided by an interactive virtual coach (Coach Anne) to help address pain-related distress and functional difficulties of chronic pain (e.g., avoidance, reactivity) over seven weeks of treatment. Preliminary findings suggest that VACT-CP is highly usable, perceived as helpful, and can help Veterans increase their pain acceptance and pain management. The primary outcomes for this project will be to complete a three-site, fully-powered efficacy trial comparing VACT-CP to an active online control condition (total n = 200) to investigate whether VACT-CP can improve pain-related functioning and quality of life. In addition, the investigators will analyze data from the VACT-CP group to assess whether the hypothesized mechanism of change (psychological flexibility) mediates the impact of pain severity on pain-related functioning.

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

The research staff collecting trial outcome data will not be informed of the participant's group.

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 by:
  • •1a at least one pain-related diagnosis indicated by an ICD-9 or -10 code related to either Musculoskeletal pain or Joint Problems/Osteoarthritis
  • •1b. minimum Grade 1 or 2 on the Graded Chronic Pain Scale
  • •Has a computer and working, high-speed wireless internet connection at home
  • •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 substance use disorder
  • •Current use of any other chronic pain-related psychological treatment
  • •Clinically significant suicidality within the past year
  • •Any cognitive or physical impairment that would interfere with study participation of using a computer and providing feedback

研究组 & 干预措施

Veteran ACT for Chronic Pain (VACT-CP)

Experimental

Participants will complete seven modules (each approximately 15 minutes) over seven weeks. The purpose of VACT-CP is to assist with at home therapeutic and behavioral self-management of chronic pain, based on the principles of acceptance and commitment therapy. Following the end of treatment (7 weeks), participants will complete post-treatment surveys at Week 7, Month 3, and Month 6 to provide feedback and information regarding 1) the intervention and 2) the potential impact of the intervention on functioning, quality of life, and other mental and physical health factors.

干预措施: Veteran ACT for Chronic Pain (VACT-CP) (Behavioral)

Online Pain School

Active Comparator

Participants will complete seven modules (each approximately 15 minutes) over seven weeks. Online Pain School is designed to balance for time participating in the intervention, and is also an active online attention control. The goal of this program will be to provide Veterans with more tools and options for pain management, and the online format will allow us to monitor website use/dose. Following the end of treatment (7 weeks), participants will complete post-treatment surveys at Week 7, Month 3, and Month 6 to provide feedback and information regarding 1) the intervention and 2) the potential impact of the intervention on functioning, quality of life, and other mental and physical health factors.

干预措施: Online Pain School (Behavioral)

结局指标

主要结局

Veteran's RAND 36 Item Health Survey (VR-36) Change

时间窗: Week 7, 3-Month Follow-Up, 6 Month Follow-Up

The Veteran's RAND 36 Item Health Survey (VR-36) is 36-item measure of health-related quality of life including physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It is often summarized into physical functioning components (PCI) and mental functioning components (MCI), and is one of the most widely utilized and valid measures of physical and psychological well-being.

Brief Pain Inventory Change

时间窗: Week 7, 3-Month Follow-Up, 6 Month Follow-Up

The Brief Pain Inventory is a widely-used assessment of both pain-relevant functioning and pain severity which is sensitive to change across numerous treatment studies. The pain severity index (BPI-Pain Severity) consists of four items used to assess pain severity and the pain interference scale (BPI-Interference) consists of 7 items that assess the degree of pain interference with functioning across 7 areas: general activity, mood, walking ability, normal work, relationships, sleep; and enjoyment in life. Items are rated on a 0-10 (0 = no pain/no interference and 10 = most pain/most interference).

次要结局

  • System Usability Scale (SUS)(Week 7)
  • Client Satisfaction Questionnaire-8 (CSQ-8)(Week 7)
  • Chronic Pain Acceptance Questionnaire (CPAQ)(Week 7, 3-Month Follow-Up, 6 Month Follow-Up)
  • Multidimensional Psychological Flexibility Inventory (MPFI)(Week 7, 3-Month Follow-Up, 6 Month Follow-Up)
  • Chronic Pain Values Inventory (CPVI)(Week 7, 3-Month Follow-Up, 6 Month Follow-Up)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (3)

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