Assessing the Efficacy of an Acceptance-Based Digital Intervention for Veterans With Chronic Pain
VACT-CP
2 other identifiers
interventional
240
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-pain
Started Jul 2024
Longer than P75 for not_applicable chronic-pain
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2023
CompletedFirst Posted
Study publicly available on registry
September 28, 2023
CompletedStudy Start
First participant enrolled
July 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2027
July 30, 2025
July 1, 2025
2.8 years
September 18, 2023
July 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Brief Pain Inventory Change
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).
Week 7, 3-Month Follow-Up, 6 Month Follow-Up
Veteran's RAND 36 Item Health Survey (VR-36) Change
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.
Week 7, 3-Month Follow-Up, 6 Month Follow-Up
Secondary Outcomes (5)
System Usability Scale (SUS)
Week 7
Client Satisfaction Questionnaire-8 (CSQ-8)
Week 7
Multidimensional Psychological Flexibility Inventory (MPFI)
Week 7, 3-Month Follow-Up, 6 Month Follow-Up
Chronic Pain Acceptance Questionnaire (CPAQ)
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
Study Arms (2)
Veteran ACT for Chronic Pain (VACT-CP)
EXPERIMENTALParticipants 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.
Online Pain School
ACTIVE COMPARATORParticipants 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.
Interventions
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 will also be presented with videos (e.g., Veteran narratives, metaphors), in-module assessments (e.g., values assessments), and interactive opportunities for goal setting.
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."
Eligibility Criteria
You may qualify if:
- Current diagnosis of non-cancer chronic pain, defined by:
- a at least one pain-related diagnosis indicated by an ICD-9 or -10 code related to either Musculoskeletal pain or Joint Problems/Osteoarthritis
- b. 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VA Office of Research and Developmentlead
- North Texas Veterans Healthcare Systemcollaborator
- VA Connecticut Healthcare Systemcollaborator
Study Sites (3)
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770, United States
VA Bedford HealthCare System, Bedford, MA
Bedford, Massachusetts, 01730-1114, United States
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216-7167, United States
Related Publications (1)
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: 40802968DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erin D. Reilly, PhD
VA Bedford HealthCare System, Bedford, MA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The research staff collecting trial outcome data will not be informed of the participant's group.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2023
First Posted
September 28, 2023
Study Start
July 31, 2024
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
October 31, 2027
Last Updated
July 30, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share