Assessing the Efficacy of an Acceptance-Based Digital Intervention for Veterans With Chronic Pain
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Veteran ACT for Chronic Pain (VACT-CP), Online Pain School.
- Кому может быть актуально
- Состояния в реестре: Chronic Pain. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Assessing the Efficacy of an Acceptance-Based Digital Intervention to Improve Functioning for Veterans With Chronic Pain
Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое Veteran ACT for Chronic Pain (VACT-CP)
Participants receive 7 online modules, provided as weekly sessions that feature Coach Anne as a virtual, animated treatment guide. All content is presented interactively, through text-based conversations with Coach Anne. Veterans will hear what Coach Anne "says" and respond to her using text-based dialogue options that will trigger different responses from Coach Anne as the conversation progresses, to allow the system to responsively interact in a personalized manner with the Veteran. Veterans w - Поведенческое Online Pain School
Participants will receive 7 modules (15 to 20 minutes each) of content based on a common non-ACT based VA treatment option, Pain School. The adaptation used for this study, "Online Pain School", will support Veterans' self-management of their chronic pain by providing informational videos on chronic pain and its health impacts, short behavioral exercises to help with pain management, and psychoeducation on different wellness techniques for their "pain management toolbox."
Первичные конечные точки
- Brief Pain Inventory Change [Срок оценки: Week 7, 3-Month Follow-Up, 6 Month Follow-Up]
- Veteran's RAND 36 Item Health Survey (VR-36) Change [Срок оценки: Week 7, 3-Month Follow-Up, 6 Month Follow-Up]
Вторичные конечные точки (5)
- System Usability Scale (SUS) [Срок оценки: Week 7]
- Client Satisfaction Questionnaire-8 (CSQ-8) [Срок оценки: Week 7]
- Multidimensional Psychological Flexibility Inventory (MPFI) [Срок оценки: Week 7, 3-Month Follow-Up, 6 Month Follow-Up]
- Chronic Pain Acceptance Questionnaire (CPAQ) [Срок оценки: Week 7, 3-Month Follow-Up, 6 Month Follow-Up]
- Chronic Pain Values Inventory (CPVI) [Срок оценки: Week 7, 3-Month Follow-Up, 6 Month Follow-Up]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
США · 3 центра
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven
- VA Bedford HealthCare System, Bedford, MA — Bedford
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas
Публикации
- Reilly ED, Grigorian HL, Heapy AA, Etingen B, Kelly MM, Wolkowicz NR, Girouard CM, Hogan TP, Bernice K, Bickmore T. Assessment of Two Online Interventions for Veterans With Chronic Pain: Protocol for a Randomized Controlled Efficacy Trial. JMIR Res Protoc. 2025 Aug 13;14:e70601. doi: 10.2196/70601. PMID 40802968
Идентификаторы
NCT: NCT06058624 · D4804-R · RX004804-01