About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Veteran ACT for Chronic Pain (VACT-CP)
BehavioralParticipants 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
BehavioralParticipants 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."
Treatment groups
Trial outcomes
Primary outcomes
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).
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.
Secondary outcomes
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.
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).
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.
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.
Sponsors and contacts
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VA Office of Research and Development
Lead sponsor
North Texas Veterans Healthcare System
Collaborator
VA Connecticut Healthcare System
Collaborator