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

ConditionChronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Veteran ACT for Chronic Pain (VACT-CP)

    Behavioral

    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

    Behavioral

    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."

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Veteran ACT for Chronic Pain (VACT-CP)Experimental treatment 1 intervention
Group B: Online Pain SchoolActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Week 7, 3-Month Follow-Up, 6 Month Follow-Up
2

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.

Time frame
Week 7, 3-Month Follow-Up, 6 Month Follow-Up

Secondary outcomes

1

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.

Time frame
Week 7
2

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).

Time frame
Week 7
3

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.

Time frame
Week 7, 3-Month Follow-Up, 6 Month Follow-Up
4

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.

Time frame
Week 7, 3-Month Follow-Up, 6 Month Follow-Up

Other outcomes

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