240 Participants Needed

Digital Intervention for Chronic Pain

(VACT-CP Trial)

Recruiting at 2 trial locations
ED
CM
Overseen ByCaitlin M Girouard, MA BA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on psychological treatments for chronic pain.

What data supports the effectiveness of this treatment for chronic pain?

Research shows that online Acceptance and Commitment Therapy (ACT) can help improve pain management and quality of life for people with chronic pain. Studies have found small to moderate positive effects on pain interference and acceptance, making it a promising option for those who have difficulty accessing traditional therapy.12345

Is the digital intervention for chronic pain safe for humans?

The research on digital Acceptance and Commitment Therapy (ACT) for chronic pain, including versions like Veteran ACT for Chronic Pain (VACT-CP), suggests it is generally safe for humans, as it is a non-drug behavioral therapy focused on improving pain management and functioning.12467

How is the Online Pain School treatment for chronic pain different from other treatments?

The Online Pain School, specifically the Veteran ACT for Chronic Pain (VACT-CP), is unique because it offers an online, non-drug approach using Acceptance and Commitment Therapy (ACT) to help veterans manage chronic pain. This digital format increases accessibility for veterans who may have difficulty accessing traditional in-person therapy due to time, resource, or location constraints.14589

Research Team

ED

Erin D. Reilly, PhD

Principal Investigator

VA Bedford HealthCare System, Bedford, MA

Eligibility Criteria

This trial is for Veterans with non-cancer chronic pain, who have internet and a computer at home. They must be able to consent and not be in any other psychological treatment for pain. Those with substance use issues, cognitive impairments that affect study participation, psychotic disorders, or recent suicidality cannot join.

Inclusion Criteria

I have chronic pain due to joint problems or osteoarthritis.
I am able to understand and sign the consent form.
Has a computer and working, high-speed wireless internet connection at home
See 1 more

Exclusion Criteria

I am currently undergoing psychological treatment for chronic pain.
You have had serious thoughts about harming yourself in the past year.
You have been diagnosed with a substance use disorder within the past month.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete seven modules of the online Veteran ACT for Chronic Pain (VACT-CP) or Online Pain School over seven weeks

7 weeks
Online participation

Follow-up

Participants complete post-treatment surveys to assess the impact of the intervention on functioning, quality of life, and other health factors

6 months
Surveys at Week 7, Month 3, and Month 6

Treatment Details

Interventions

  • Online Pain School
  • Veteran ACT for Chronic Pain (VACT-CP)
Trial Overview The study compares two online programs: Veteran ACT for Chronic Pain (VACT-CP) and Online Pain School. It aims to see which better helps Veterans manage their chronic pain, improve daily functioning, and enhance quality of life through educational content.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Veteran ACT for Chronic Pain (VACT-CP)Experimental Treatment1 Intervention
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 II: Online Pain SchoolActive Control1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

North Texas Veterans Healthcare System

Collaborator

Trials
39
Recruited
4,005,000+

VA Connecticut Healthcare System

Collaborator

Trials
86
Recruited
8,800+

Findings from Research

The study found that online Acceptance and Commitment Therapy (ACT) for chronic pain is feasible, with a 45% recruitment rate and a retention rate of 76-78% for follow-up assessments among 63 randomized participants.
Participants receiving online ACT reported significantly greater improvements in their condition, with 56% rating themselves as 'much improved' compared to only 20% in the control group, indicating potential efficacy for further investigation in larger trials.
Feasibility randomized-controlled trial of online Acceptance and Commitment Therapy for patients with complex chronic pain in the United Kingdom.Scott, W., Chilcot, J., Guildford, B., et al.[2019]
The study found that Internet-delivered acceptance and commitment therapy (iACT) significantly improved pain interference, depression, anxiety, and pain intensity in adults with chronic pain, with large effect sizes for pain interference (d = 0.99) and pain intensity (d = 1.2).
Improvements were maintained at a 12-month follow-up, suggesting that the novel microlearning format of iACT is an effective long-term intervention for managing various aspects of chronic pain.
Internet-delivered acceptance and commitment therapy as microlearning for chronic pain: A randomized controlled trial with 1-year follow-up.Rickardsson, J., Gentili, C., Holmström, L., et al.[2021]
A systematic review of 20 articles found that online Acceptance and Commitment Therapy (ACT) interventions for chronic pain are effective, particularly in studies that included randomized controlled trials (RCTs).
Most interventions were designed according to ACT principles and often included guidance, but many studies lacked detailed information on how design choices were made to enhance user engagement and adherence, which are important for maximizing effectiveness.
Online Acceptance and Commitment Therapy (ACT) interventions for chronic pain: A systematic literature review.van de Graaf, DL., Trompetter, HR., Smeets, T., et al.[2022]

References

Feasibility randomized-controlled trial of online Acceptance and Commitment Therapy for patients with complex chronic pain in the United Kingdom. [2019]
Internet-delivered acceptance and commitment therapy as microlearning for chronic pain: A randomized controlled trial with 1-year follow-up. [2021]
Online Acceptance and Commitment Therapy (ACT) interventions for chronic pain: A systematic literature review. [2022]
An Online Acceptance and Mindfulness Intervention for Chronic Pain in Veterans: Development and Protocol for a Pilot Feasibility Randomized Controlled Trial. [2023]
Internet-delivered acceptance and commitment therapy (iACT) for chronic pain-feasibility and preliminary effects in clinical and self-referred patients. [2022]
ACTsmart: Guided Smartphone-Delivered Acceptance and Commitment Therapy for Chronic Pain-A Pilot Trial. [2023]
Implementing an acceptance and commitment therapy group protocol with veterans using VA's stepped care model of pain management. [2018]
Cognitive behavioral therapy for chronic pain in veterans: Evidence for clinical effectiveness in a model program. [2023]
Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial. [2023]