Clinical trial NCT06058624: Assessing the Efficacy of an Acceptance-Based Digital Intervention for Veterans With Chronic Pain
Official title: Assessing the Efficacy of an Acceptance-Based Digital Intervention to Improve Functioning for Veterans With Chronic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic Pain
Internet-Based Intervention
Psychosocial Intervention
Acceptance and Commitment Therapy
Quality of Life
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: North Texas Veterans Healthcare System
name: VA Connecticut Healthcare System
First posted: 2023-09-28
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arm, randomized clinical trial comparing two online pain self-management interventions: Veteran ACT for Chronic Pain and Online Pain School. Both interventions are matched for attention and time, with 7 modules (each about 15 - 20 minutes) received over 7 weeks.
Primary purpose: TREATMENT

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.

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. a 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

Primary outcomes:
measure: Brief Pain Inventory Change
timeFrame: Week 7, 3-Month Follow-Up, 6 Month Follow-Up
measure: Veteran's RAND 36 Item Health Survey (VR-36) Change
timeFrame: Week 7, 3-Month Follow-Up, 6 Month Follow-Up
Secondary outcomes:
measure: System Usability Scale (SUS)
timeFrame: Week 7
measure: Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: Week 7
measure: Multidimensional Psychological Flexibility Inventory (MPFI)
timeFrame: Week 7, 3-Month Follow-Up, 6 Month Follow-Up
measure: Chronic Pain Acceptance Questionnaire (CPAQ)
timeFrame: Week 7, 3-Month Follow-Up, 6 Month Follow-Up
measure: Chronic Pain Values Inventory (CPVI)
timeFrame: Week 7, 3-Month Follow-Up, 6 Month Follow-Up
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
city: Bedford
country: United States
facility: VA Bedford HealthCare System, Bedford, MA
state: Massachusetts
city: Dallas
country: United States
facility: VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
state: Texas
Study officials:
affiliation: VA Bedford HealthCare System, Bedford, MA
name: Erin D. Reilly, PhD
role: PRINCIPAL_INVESTIGATOR
References: