Advancing Online Psychology Tools for Chronic Pain (ADOPT-CP)
Advancing Online Psychology Tools for Chronic Pain (ADOPT-CP): Feasibility of a Scalable Digital Psychology Intervention and AI-Powered Support for Patients on the Waitlist for Pain Services
Chronic pain affects more than 20% of Canadians and is associated with significant impacts on physical function, mental health, and quality of life. Despite efforts to improve access to multidisciplinary pain care through centralized referral systems, many patients continue to experience prolonged wait times before receiving treatment.
This study evaluates a self-guided digital psychological intervention designed to support chronic pain self-management during the waiting period for specialized pain care. The intervention was developed through a collaboration between the Transitional Pain Service and ManagingLife and aims to improve access to evidence-based psychological support, enhance self-management skills, and reduce pain-related distress among individuals living with chronic pain.
연구 개요
상태
상세 설명
The Advancing Online Psychology Tools for Chronic Pain (ADOPT-CP) intervention provides participants with access to the Manage My Pain (MMP) platform, including a self-guided Acceptance and Commitment Therapy (ACT)-based digital psychology program and Solace, an artificial intelligence (AI)-enabled conversational support tool for chronic pain. Together, these tools are designed to support pain self-management, emotional coping, and engagement in care.
This study will evaluate the feasibility, acceptability, and preliminary clinical effects of the ADOPT-CP intervention among individuals waiting to access multidisciplinary chronic pain services through the Toronto Academic Pain Medicine Institute (TAPMI). The intervention aims to provide accessible psychological support and self-management resources during the waiting period for specialized pain care.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Didem Bozak
- 전화번호: 416-323-6008
- 이메일: didem.bozak@wchospital.ca
연구 연락처 백업
- 이름: Adriano Nella, MSc
- 전화번호: 5977 416-323-6400
- 이메일: Adriano.Nella@wchospital.ca
연구 장소
-
-
Ontario
-
Toronto, Ontario, 캐나다, M5S 1B2
- Women's College Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Must be deemed to have capacity to provide informed consent;
- Must sign and date the informed consent form;
- Must state willingness to comply with all study procedures;
- Must be at least 18 years of age;
- Must be referred to TAPMI;
- Must have either fibromyalgia or chronic pelvic pain
- Must be on the waitlist at TAPMI;
- Must have access to a device that can connect to the Internet with access to email.
Exclusion Criteria:
- Currently engaged in psychotherapy or engaged in psychotherapy within the last month at the time of enrolment;
- Unable to read, understand, or communicate in English sufficiently to provide informed consent and complete the study procedures and questionnaires;
- Has active serious mental illness or psychiatric instability that, in the opinion of the research team, may impair the ability to safely participate in the study or to provide informed consent (e.g., active psychosis, active mania);
- Has a visual, auditory, or other functional impairment that would prevent independent access to and use of the digital intervention and study procedures on an internet-enabled device.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Intervention Group
The ADOPT-CP intervention includes the Manage My Pain (MMP) app with integrated tools: a customizable pain tracker for monitoring symptoms and generating reports, the Pain Guide with educational content on pain management, a self-guided Acceptance and Commitment Therapy (ACT)-based psychology program, and Solace, an AI-driven conversational agent designed to provide structured, evidence-based psychological support for chronic pain self-management.
|
The intervention, Manage My Pain (MMP), is a clinically validated app-based platform that supports individuals with chronic pain in self-managing their symptoms and improving communication and engagement with their care team.
|
|
활성 비교기: Control Group
The control group will receive treatment as usual plus weekly emailed resources.
These resources include materials introduced during the TAPMI orientation session, including Power Over Pain and Progress Over Pain.
|
Weekly emailed pain self-management resources introduced during the Toronto Academic Pain Medicine Institute (TAPMI) orientation
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Trial feasibility
기간: 10 weeks
|
Measured according to the CONSORT criteria and include: eligibility rate, recruitment rate, retention rate, measure completion, absence of or minor adverse events.
|
10 weeks
|
|
Engagement with the digital ADOPT-CP intervention
기간: 10 weeks
|
Measured via MMP app analytics (usage rates, completion of psychology program, etc.)
|
10 weeks
|
|
Acceptability and Appropriateness of the ADOPT-CP intervention
기간: 10 weeks
|
The Treatment Evaluation Inventory-Short Form (TEI-SF) is a self-report measure assessing the acceptability and perceived appropriateness of a treatment or intervention, with higher scores indicating greater treatment acceptability.
|
10 weeks
|
|
Acceptability and Adherence of the ADOPT-CP intervention
기간: 10 weeks
|
The Treatment Acceptability/Adherence Scale (TAAS) is a self-report measure assessing perceived acceptability of an intervention and anticipated or actual adherence, with higher scores indicating greater acceptability and adherence.
|
10 weeks
|
|
Experience using the ADOPT-CP intervention
기간: 14 weeks
|
a semi-structured interview guide will be used to explore participant experiences, barriers and facilitators to use, acceptability, engagement, and opportunities to refine the digital intervention prior to a larger trial.
|
14 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Quality of Life and Pain Interference
기간: 10 weeks
|
Modified PROMIS-29 Health Domains (Quality of Life and Pain Interference 8a): A validated patient-reported outcome system assessing the impact of health conditions on physical, mental, and social functioning. Higher scores indicate greater pain interference and worse health-related quality of life, while lower scores indicate better functioning and quality of life. |
10 weeks
|
|
Pain Acceptance
기간: 10 weeks
|
Measured by the Chronic Pain Acceptance Questionnaire-Short Form: A validated self-report measure of acceptance of chronic pain. Higher scores indicate greater acceptance of chronic pain, including continued activity engagement and reduced avoidance of pain-related experiences. |
10 weeks
|
|
Psychological Flexibility
기간: 10 weeks
|
Measured by the Acceptance and Action Questionnaire-II (AAQ-II): A validated self-report measure of psychological inflexibility and experiential avoidance. Higher scores indicate greater psychological inflexibility and experiential avoidance, while lower scores indicate greater psychological flexibility. |
10 weeks
|
|
Kinesiophobia
기간: 10 weeks
|
Measured by the Tampa Scale of Kinesiophobia (TSK): a validated self-report questionnaire used to assess fear of movement and fear of re-injury.
Higher scores indicate greater fear of movement.
|
10 weeks
|
|
Pain Resiliency
기간: 10 weeks
|
Measured by the Pain Resiliency Scale: Measures how well a person can adapt and maintain function despite chronic pain. Higher scores indicate greater resilience in coping with chronic pain, while lower scores indicate reduced adaptive coping. |
10 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Tania Di Renna, MD, FRCPC, Women's College Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
At this time, no external data sharing arrangements or future secondary use arrangements are planned. Study data will be retained and used only for the purposes described in this protocol. If future secondary use or collaboration with internal or external investigators is proposed at a later date, this would occur only in accordance with participant consent, WCH REB requirements, and any required data sharing agreements or institutional approvals.
Results from this study may be disseminated through academic publications, presentations, and reports. Only aggregate or de-identified information will be used for these purposes. No participant-identifiable information will be included in any publication or dissemination arising from this study. Study data will not be shared with individuals outside the research team for secondary use.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .