Advancing Online Psychology Tools for the Transitional Pain Service (ADOPT-TPS): Pilot Feasibility and Efficacy Randomized-Controlled Trial of a Scalable, Online Psychology Intervention for Post-Surgical Pain and Opioid Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 4
- 主要终点
- Feasibility of the online ACT program as assessed by the Feasibility Survey
研究概览
简要总结
This project will evaluate the feasibility of a new fully self-guided online Acceptance and Commitment Therapy (ACT) program entitled Advancing Online Psychology Tools for the Transitional Pain Service (ADOPT-TPS), developed on an online health application platform called Manage My Pain (MMP). The ACT program is designed to teach mindfulness skills and provide psychoeducation about post-surgical pain. The feasibility of the self-guided online program will be compared to a pre-existing psychologist-guided workshop that delivers the same program. It is anticipated that the self-guided online ACT program will be deemed feasible by participants.
详细描述
The Transitional Pain Service (TPS) at Toronto General Hospital is a multidisciplinary treatment program that aims to prevent chronic post-surgical pain (CPSP) and persistent opioid use after surgery. CPSP is a major public health concern impacting from 10% up to 70% of patients, depending on the type of surgery. Those experiencing CPSP are at higher risk for prolonged opioid use, which introduces challenges like addiction, misuse, and overdose. Acceptance and Commitment Therapy (ACT) is an evidence-based psychology intervention that is effective in reducing patients' risk of CPSP and opioid use. However, access to this intervention is currently limited to predominantly in-person, specialized hospital-based clinic settings like the TPS, which prioritize patients at highest risk for CPSP and often require physician referrals for quick access. There is a need for such treatment approaches to spread to other institutions and to be available for lower-risk post-surgery patients, yet the shortage of specialized pain psychologists creates a barrier to widespread dissemination. The current project will evaluate the feasibility of a novel fully self-guided online ACT intervention entitled Advancing Online Psychology Tools for the Transitional Pain Service (ADOPT-TPS), developed on a mobile health application platform called Manage My Pain (MMP). A randomized, controlled pilot feasibility trial will evaluate the efficacy of ADOPT-TPS by comparing it to a pre-existing psychologist-guided workshop. Once tested, this scalable, evidence-based online intervention can be easily implemented at institutions across Canada and beyond to address CPSP and opioid use without the need for specialized pain psychologists on staff.
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
Only the participants and the research coordinator will know which group (self-guided vs. psychologist-guided) an individual participant will be randomly assigned to.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who received a post-surgical referral to the TPS
- •Patients who have access to a device that can connect to the Internet
排除标准
- •Patients who have received TPS psychology treatment
- •Patients with a known history of serious mental illness (e.g., psychosis and/or active mania)
- •Patients who have limited comprehension of English or comprehension deficits due to dementia
研究组 & 干预措施
Self-guided Online ACT
The intervention is a self-guided ACT program delivered on an online platform. The program is developed based on the psychologist-guided ACT group intervention for chronic pain and opioid use after surgery.
干预措施: Self-Guided Online ACT Program (Device)
Psychologist-guided Online ACT
The psychologist-guided ACT group workshop is an evidence-based psychology intervention for chronic pain and opioid use after surgery.
干预措施: Treatment As Usual (Other)
结局指标
主要结局
Feasibility of the online ACT program as assessed by the Feasibility Survey
时间窗: Participants will be sent a link to fill out the measure within 1 week of completing their respective program.
A 10-item Likert scale (min possible score = 10, max possible score = 70). Higher scores indicate greater feasibility.
Acceptability of the online ACT program as assessed by the Treatment Evaluation Inventory - Short Form
时间窗: Participants will be sent a link to fill out the measure within 1 week of completing their respective program.
A 9-item Likert scale (min possible score = 9, max possible score = 45). Higher scores indicate greater acceptability.
Retrospective Semi-structured Interview
时间窗: Participants will be sent an invitation for an interview within 1 month after completing their respective program
A brief interview with a randomized subset of participants
Treatment Adherence as assessed by the Integration of ACT Skills Survey
时间窗: Participants will be sent a link to complete the measure within 1 month after completing their respective program.
A 5-item Likert scale (min possible score = 5, max possible score = 35). Higher scores indicate greater treatment adherence
次要结局
- Anxiety symptoms as assessed by the PROMIS Emotional Distress - Anxiety - Short Form 8A(Participants will be sent a link to fill out the measure prior to starting their respective program, within 1 week of completing their respective program, and 1 month after completing their respective program.)
- Pain Medication Misuse as assessed by the PROMIS Prescription Pain Medication Misuse Scale - Short Form 7a(Participants will be sent a link to fill out the measure prior to starting their respective program, within 1 week of completing their respective program, and 1 month after completing their respective program.)
- Depressive symptoms as assessed by PROMIS Emotional Distress - Depression - Short Form 8b(Participants will be sent a link to fill out the measure prior to starting their respective program, within 1 week of completing their respective program, and 1 month after completing their respective program.)
- Psychological Inflexibility in Pain as measured by the Psychological Inflexibility in Pain Scale(Participants will be sent a link to fill out the measure prior to starting their respective program, within 1 week of completing their respective program, and 1 month after completing their respective program.)
- Use of Study Platform as assessed by the Use of Manage My Pain Platform Survey(Participants will be sent a link to fill out the measure within 1 week of completing the respective program, and 1 month after completing their respective program.)
- Pain Intensity as assessed by the Pain Numerical Rating Scale(Participants will be sent a link to fill out the measure prior to starting their respective program, within 1 week of completing their respective program, and 1 month after completing their respective program.)
- Pain Interference as assessed by the PROMIS Pain Interference Scale - Short Form 8a(Participants will be sent a link to fill out the measure prior to starting their respective program, within 1 week of completing their respective program, and 1 month after completing their respective program.)
- Pain Catastrophizing as assessed by the Pain Catastrophizing Scale(Participants will be sent a link to fill out the measure prior to starting their respective program, within 1 week of completing their respective program, and 1 month after completing their respective program.)