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

Chronic Pain Clinical Trial

— VACT-CP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06058624
• Other study ID #: D4804-R
• Secondary ID: RX004804-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 31, 2024
• Est. completion date: October 31, 2027

Study information

• Verified date: May 2024
• Source: VA Office of Research and Development
• Contact: Erin D Reilly, PhD
• Phone: (781) 687-4191
• Email: Erin.Reilly[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: October 31, 2027
• Est. primary completion date: May 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• 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.
• 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."

Locations

Country	Name	City	State
United States	VA Bedford HealthCare System, Bedford, MA	Bedford	Massachusetts
United States	VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX	Dallas	Texas
United States	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	North Texas Veterans Healthcare System, VA Connecticut Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	System Usability Scale (SUS)	The SUS a 10-item measure, scored on a 5-point Likert scale, that assesses human-computer interaction. A SUS score above 68 is regarded as above average, and a SUS score above 80 is regarded as high and a score above which participants are likely to recommend the product to friends. The SUS generates a subjective evaluation score using a globally accepted scale and to understand if the system in its current form is sufficiently usable.	Week 7
Secondary	Client Satisfaction Questionnaire-8 (CSQ-8)	This 8-item scale measures global satisfaction, perceived quality, and effectiveness of the proposed mental health treatment. This scale has been used in mental health and other health centers and has acceptable internal consistency (.83-.93).	Week 7
Secondary	Multidimensional Psychological Flexibility Inventory (MPFI)	A 60-item self-report measure that assesses psychological flexibility, the main mechanism of change proposed in our theoretical model. The MPFI is conceptually grounded in the ACT Hexaflex model, and assesses six dimensions of flexibility (i.e., present moment awareness, self as context, acceptance, contact with values, committed action, cognitive defusion), six dimensions of inflexibility (cognitive fusion, self as context, inaction, lack of contact with values, lack of contact with the present moment, experiential avoidance), and 2 global composite dimensions. The MFPI is sensitive to clinical change and the scales have demonstrated excellent internal consistencies across several subpopulations.	Week 7, 3-Month Follow-Up, 6 Month Follow-Up
Secondary	Chronic Pain Acceptance Questionnaire (CPAQ)	A 20-item survey measuring recognition of pain as not negating the ability to live valued life. Pain willingness reflects a pattern of refraining from attempts to control or avoid pain. Higher CPAQ scores indicate higher activity engagement, pain willingness, and overall pain acceptance. The CPAQ is a well-validated measure with high internal consistency and test-retest reliability.	Week 7, 3-Month Follow-Up, 6 Month Follow-Up
Secondary	Chronic Pain Values Inventory (CPVI)	A 12-item self-report measure of the extent to which the patient is living in accordance with their values in areas such as work, health, and family, which is related to lower perceived disability and pain-related anxiety, as well as greater reported patient functioning even in the context of high levels of pain.	Week 7, 3-Month Follow-Up, 6 Month Follow-Up