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

NCT ID: NCT06058624

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2027-10-31

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.

Detailed Description

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Veteran ACT for Chronic Pain (VACT-CP)

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.

Group Type: EXPERIMENTAL

Veteran ACT for Chronic Pain (VACT-CP)

Intervention Type: BEHAVIORAL

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.

Online Pain School

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.

Group Type: ACTIVE_COMPARATOR

Online Pain School

Intervention Type: BEHAVIORAL

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."

Interventions

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 will also be presented with videos (e.g., Veteran narratives, metaphors), in-module assessments (e.g., values assessments), and interactive opportunities for goal setting.

Intervention Type: BEHAVIORAL

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."

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

North Texas Veterans Healthcare System

FED

Sponsor Role: collaborator

VA Connecticut Healthcare System

FED

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erin D. Reilly, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Bedford HealthCare System, Bedford, MA

Locations

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, United States

Site Status: RECRUITING

VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, United States

Site Status: RECRUITING

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Erin D Reilly, PhD

Role: CONTACT

Erin.Reilly@va.gov

(781) 687-4191

Caitlin M Girouard, MA BA

Role: CONTACT

Caitlin.Girouard@va.gov

(781) 687-4192

Facility Contacts

Alicia Heapy, PhD

Role: primary

alicia.heapy@va.gov

203-932-5711 ext. 2299

Paula Mroz, PhD

Role: primary

paula.mroz@va.gov

781-687-3299

Bella Etingen, PhD

Role: primary

bella.etingen@va.gov

708-202-8387 ext. 24922

References

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.

Reference Type: DERIVED

PMID: 40802968 (View on PubMed)

Other Identifiers

RX004804-01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

D4804-R

Identifier Type: -

Identifier Source: org_study_id