Digital Intervention for Chronic Pain

(VACT-CP Trial)

Recruiting at 2 trial locations

Overseen By Caitlin M Girouard, MA BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Psychotic disorder, Substance use, Suicidality, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 7 weeks

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Veterans with non-cancer chronic pain improve their daily lives through two online programs. It compares the effectiveness of Veteran ACT for Chronic Pain (VACT-CP), which uses acceptance and commitment therapy, and Online Pain School, which offers pain management tools. Participants complete short, weekly online modules and provide feedback on how the programs affect their functioning and quality of life. Veterans with a computer, a stable internet connection, and a current diagnosis of musculoskeletal pain or joint problems are well-suited for this trial. As an unphased trial, this study offers Veterans the opportunity to explore innovative online programs that may enhance their 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that online pain management programs, such as the Online Pain School, are generally safe. One study found that telemedicine, or healthcare over the internet, is as effective as in-person visits for managing chronic pain. This indicates that online programs can safely assist in pain management without requiring patients to leave home.

For the Veteran ACT for Chronic Pain (VACT-CP), studies have also shown positive results. Research on similar programs found they can reduce pain and improve mood without causing harm. Acceptance and Commitment Therapy (ACT), used in VACT-CP, is well-received and has been shown to benefit individuals with chronic pain.

Both treatments focus on managing pain through online sessions. No reports of serious side effects have emerged, making them safe options for those seeking to manage chronic pain at home. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Digital Intervention for Chronic Pain trial because it explores innovative online methods to manage chronic pain, specifically tailored for veterans. Unlike traditional treatments like medications or in-person therapy sessions, this trial uses two distinct online programs. The Online Pain School provides veterans with accessible tools for pain management and lets researchers monitor engagement. Meanwhile, the Veteran ACT for Chronic Pain (VACT-CP) leverages acceptance and commitment therapy principles for self-management at home. This digital approach not only aims to enhance quality of life but also provides flexible and scalable options for veterans, making it a promising alternative to conventional methods.

What evidence suggests that this trial's treatments could be effective for chronic pain?

Research has shown that Acceptance and Commitment Therapy for Chronic Pain (ACT-CP), which participants may receive in the Veteran ACT for Chronic Pain (VACT-CP) arm, helps people manage chronic pain. This therapy encourages individuals to change their actions based on personal values, leading to better pain control. It is well-respected and approved by Veterans Affairs for managing chronic pain. Meanwhile, studies on online pain management programs, such as the Online Pain School, another treatment arm in this trial, indicate that these programs can increase knowledge about pain management and offer some relief, though they might not be as effective as in-person sessions. Both treatments in this trial aim to help individuals take control of their pain and improve their quality of life. ^{1 6 7 8 9}

Who Is on the Research Team?

Erin D. Reilly, PhD

Principal Investigator

VA Bedford HealthCare System, Bedford, MA

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Veteran ACT for Chronic Pain (VACT-CP) Experimental Treatment 1 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 School Active Control 1 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.

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A study involving 50 Veterans demonstrated that Acceptance and Commitment Therapy (ACT) significantly reduced pain interference, improved illness-focused coping, and decreased global distress after a group-based intervention.

The intervention was conducted within the VA's Stepped Care Model of Pain Management, indicating that ACT can be an effective secondary treatment option for managing chronic pain in Veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing an acceptance and commitment therapy group protocol with veterans using VA's stepped care model of pain management. Cosio, D., Schafer, T.[2018]

The RESOLVE trial is a large-scale, 3-arm randomized control trial designed to compare the effectiveness of telephonic/video and online CBT for chronic pain against usual care, involving diverse populations across urban and rural areas.

This study aims to assess not only the clinical effectiveness of these CBT interventions in reducing pain severity but also their cost-effectiveness, potentially improving access to treatment for underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Mayhew, M., Balderson, BH., Cook, AJ., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The internet-delivered Acceptance and Commitment Therapy (iACT) was found to be feasible and acceptable for chronic pain patients, with significant improvements in various outcomes such as pain interference and psychological inflexibility, indicating its potential effectiveness.

Preliminary results showed that participants experienced meaningful reductions in pain intensity, anxiety, and depressive symptoms, with improvements sustained at a one-year follow-up, suggesting that iACT could be a valuable treatment option for chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-delivered acceptance and commitment therapy (iACT) for chronic pain-feasibility and preliminary effects in clinical and self-referred patients. Rickardsson, J., Zetterqvist, V., Gentili, C., et al.[2022]

The Veterans Health Administration is developing an online program called Veteran ACT for Chronic Pain (VACT-CP) to help veterans manage chronic pain through acceptance and commitment therapy (ACT), which has a strong evidence base for improving pain outcomes.

A pilot feasibility randomized controlled trial (RCT) is currently underway with 40 participants to assess the usability of the VACT-CP system, aiming to provide insights into treatment satisfaction and pain-related functioning by late 2023.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Online Acceptance and Mindfulness Intervention for Chronic Pain in Veterans: Development and Protocol for a Pilot Feasibility Randomized Controlled Trial. Reilly, ED., Kathawalla, UK., Robins, HE., et al.[2023]

The ACTsmart intervention, a smartphone-delivered acceptance and commitment therapy, showed significant improvements in pain interference among 34 adults with chronic pain after 8 weeks of treatment, with a large effect size (d = -1.01).

All secondary outcomes, including psychological flexibility and quality of life, also improved significantly and these benefits were maintained for up to 12 months, suggesting that ACTsmart is an effective and accessible treatment option for chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACTsmart: Guided Smartphone-Delivered Acceptance and Commitment Therapy for Chronic Pain-A Pilot Trial. Gentili, C., Zetterqvist, V., Rickardsson, J., et al.[2023]

The VA's cognitive behavioral therapy for chronic pain (CBT-CP) has shown significant effectiveness in improving various patient outcomes, including pain intensity and quality of life, based on a review of 1,331 Veterans treated from 2012 to 2018.

Patients experienced large reductions in pain catastrophizing (Cohen's d = 0.78) and medium to large improvements in other areas such as depression and physical quality of life, indicating that CBT-CP is a safe and effective nonpharmacological treatment for chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for chronic pain in veterans: Evidence for clinical effectiveness in a model program. Murphy, JL., Cordova, MJ., Dedert, EA.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38754282/

Evaluation of the effectiveness of the web-based chronic ... These results show that the web-based educational intervention positively increased students' knowledge of chronic pain management and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12443155/

The effectiveness of telemedicine in chronic pain ... Our study demonstrated no significant difference in the proportion of successful pain treatment outcomes when telemedicine pain services were ...

3. pcori.org pcori.org/research-results/2021/comparing-effectiveness-two-online-programs-treating-chronic-pain

Comparing the Effectiveness of Two Online Programs for ... While most CBT programs have multiple sessions, a one-session class on pain relief skills may help more people reduce their chronic pain.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/msc.1929

Online Pain Management During Covid-19: Efficacy Assessment Some patients appear to obtain significant benefit from online PMPs, but this appeared to be to a lesser extent than face-to-face PMPs.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1526590018303572

The Pain Course: 12- and 24-Month Outcomes From a ... This article presents the long-term outcome data of an established Internet-delivered pain management program for adults with chronic pain. The clinical ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39422992

Outcomes of a Remotely Delivered Complementary and ... Outcomes of a Remotely Delivered Complementary and Integrative Health Partnered Intervention to Improve Chronic Pain and Posttraumatic Stress Disorder ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1471595324001148

Evaluation of the effectiveness of the web-based chronic ... In the literature, data on the effectiveness of web-based education on chronic pain management education of nursing students are limited. Design. This was a ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06804239

Improving Activity in Adults With Chronic Pain With Online ... Outcomes of interest include: i. Changes in activity and sleep over time when online resources are paired with using a wearable activity tracker (Fitbit Inspire ...

9. nature.com nature.com/articles/s41598-021-86156-8

The effect of a smartphone-based pain management ... Pediatric chronic pain (i.e., pain lastinglonger than 3 months) is a serious developmental health concern leading toconsiderable physical and ...