The aim in phase 1 was to gather qualitative feedback on the VACT-CP system from 10 to 12 chronic pain clinical care providers, as well as identify barriers and facilitators for VACT-CP referrals and implementation in the VA Bedford Healthcare System.
In phase 1, we conducted semistructured interviews with clinical care providers (n=10) at the VA Bedford Healthcare System, whose work is at least partially related to issues of chronic pain. Participants were recruited using flyers posted around the facility in areas that serve veterans with chronic pain as well as snowball recruitment methods. To ensure a representative mix of clinical care pain providers, we aimed to recruit 2 to 3 psychologists, 2 to 3 nurses, 2 to 3 physicians, and 2 to 3 psychiatrists. The inclusion criteria were as follows: (1) currently working at the VA Bedford Healthcare System or one of its affiliated community-based outpatient clinics in a clinical capacity and (2) currently seeing veterans to assist in their management of chronic pain. The exclusion criterion was any cognitive or physical impairment (eg, auditory or sight issues) that would interfere with aspects of study participation that require using a computer or giving verbal feedback.
Interested individuals were briefly screened by telephone for eligibility and scheduled for their hour-long session. After providing informed consent, eligible participants completed a quantitative survey and a qualitative interview. The quantitative survey included a brief (5-minute) questionnaire related to their work background and individual demographics. The qualitative interviews were audio recorded for formative assessment of the potential benefits, concerns, and institutional VHA dissemination issues for the VACT-CP intervention using a semistructured interview guide and a
The demographics questionnaire included basic, nonidentifying information, including participant age, ethnicity, race, and education. The work history survey included questions created specifically for this study related to working with patients who have chronic pain, including the provider’s current position, past experiences as a health or mental health provider specific to working with patients with chronic pain, length of time in their current position, past specialized training on treating chronic pain, and information related to making any prior referrals to online or technology-mediated health interventions or resources. The qualitative interview included open-ended questions related to palatability of the intervention; feasibility of engagement with veterans with chronic pain; interest in, or potential concerns regarding, referring veterans to such a program; and reactions to a short walk-through of the intervention. Questions about palatability were based on the “organizational perspective” components of the Practical, Robust Implementation and Sustainability Model [
After data collection, we used provider feedback to (1) understand the acceptability and potential usability of the platform in other settings (eg, at the veteran’s home), (2) examine provider attitudes toward the VACT-CP system, (3) address any technological or system-specific concerns, and (4) modify potential plans for the future VACT-CP phase 2 usability assessment. Modifications to the interface and protocol were based on (1) acceptability and feasibility of the VACT-CP platform and potential treatment components and (2) qualitative feedback obtained from providers. Individual qualitative interviews will be analyzed at the end of the full study via the consensual qualitative research (CQR) approach. The initial codebook will be used by 2 to 3 coders throughout the data analysis process to foster multiple perspectives until consensus is reached among the coders about the meaning of the data. In addition, at least 1 auditor will check the work of the primary team of coders and serve to minimize potential bias.
We will report the frequency of emerging domains and themes. Themes will then be categorized according to the following CQR groupings: general (include all or all but one of the cases), typical (include more than half of the cases up to the cutoff for general), and variant (at least 2 cases up to the cutoff for typical). We will use these data to discuss broader scientific and implementation-related barriers and facilitators for interventions for patients with chronic pain within the VA system. Full data for this phase will be analyzed at the end of the completed study.
The objective in phase 2 was to conduct an iterative usability assessment by pilot-testing VACT-CP components, including the format, digital ECA guide (
Veteran participants for phase 2 were recruited through a variety of methods, including through providers who shared information about the study with potential participants, posting flyers throughout the hospital, and sending mailers to veterans who received treatment for chronic pain within the past 6 months as identified via a medical chart review. The inclusion criteria were as follows: (1) veteran aged ≥18 years; (2) current diagnosis of noncancer chronic pain; (3) competent to provide written informed consent; and (4) has a working, high-speed wireless internet connection at home or is willing to access the website at the VA Bedford Healthcare System using a provided laptop computer in a secure space. The exclusion criterion was any cognitive or physical impairment (eg, auditory or sight issues) that would interfere with aspects of study participation that require using a computer or giving verbal feedback.
We aimed to have 3 different usability testing waves, with at least 1 week between each wave to allow enough time to iteratively address any functionality issues or concerns with the user interface. The choice of 4 to 5 participants per wave was based on the finding that approximately 80% of usability problems can be detected using a sample of 4 to 5 participants [
Demographic measures included questions on pain type and duration, age, gender identity, race, ethnicity, and education level. Additional measures will include the Patient Health Questionnaire-9 [
The Media and Technology Use and Attitudes Scale [
The System Usability Scale (SUS) [
The usability survey items are adapted from an existing set of usability questions to make the questions specific to the VACT-CP treatment and are informed by the Unified Theory of Acceptance of Technology [
Participants were observed while working with the VACT-CP system, including being video recorded and asked questions by an interviewer. The interview guide (
Between each wave of testing, information specific to usability issues was gathered and analyzed to address any technological issues and revise content. Modifications to the website, module structure, and overall VACT-CP website framework were made between each wave based upon acceptability and feasibility of the online treatment and qualitative feedback obtained from patients.
Similar to phase 1, the video recordings and notes made during the qualitative portion of user testing will be transcribed and analyzed using Excel (Microsoft Corp). The quantitative data from the SUS and usability survey will be used to obtain scale scores that describe each veteran’s general perceptions and opinions of the usability and content of the VACT-CP system. This feedback will then be reported in conjunction with qualitative usability and acceptability data, which will be analyzed using the modified CQR approach also planned for in phase 1. In phase 2, the themes generated by these qualitative data will be used to identify user system issues, general trends in use of the website, content issues, how well users can complete an assigned task on the VACT-CP system, and where they are encountering problems. Using this method, we will classify all general comments regarding usability as necessary to include in iterative development and site changes, whereas variant and typical usability concerns will be discussed within the research group to decide upon potential ways to incorporate this feedback into future intervention refinement. Full analysis of these data is ongoing, although initial general usability issues have been resolved, and suggestions for website refinement have already been integrated into the VACT-CP system.
We will conduct a stage IB pilot feasibility RCT to assess the usability, feasibility, and acceptability of the VACT-CP system compared with a WL+TAU control group. This will include (1) evaluating the usability of the VACT-CP system; (2) assessing the relative feasibility and acceptability of the VACT-CP intervention procedure and WL+TAU control, including ease of recruitment, retention in each condition, treatment receptivity, attrition and retention in each condition, sustained VACT-CP website use, and the assessment process; and (3) describing changes in pain acceptance, valued living, mental and physical functioning, pain-related interference in daily functioning, and behavioral avoidance for each group. This trial has been registered on ClinicalTrials.gov (NCT03655132).
We aim to recruit and complete baseline assessments for up to 60 participants over 15 months to allow for the required 40 participants to be screened as eligible and successfully randomized. Participants will be screened based on the inclusion and exclusion criteria. The inclusion criteria will include (1) veteran aged ≥18 years; (2) current diagnosis of noncancer chronic pain (as noted in the phase 2 inclusion criteria); (3) has a working, high-speed wireless internet connection at home or is willing to access the website over the 7-week intervention at the VA Bedford Healthcare System using a provided laptop computer in a secure space; and (4) competent to provide written informed consent. The exclusion criteria will include (1) any current or lifetime Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), psychotic disorder; (2) current or recent (within 1 month of study entry) DSM-5 alcohol or drug use disorder; (3) current use of any other chronic pain–related behavioral or psychological treatment; (4) any cognitive impairment that would interfere with study participation; (5) clinically significant suicidality within the past year; (6) presence of any clinical features requiring a higher level of care (inpatient or partial hospital treatment); and (7) any cognitive or physical impairment that would interfere with aspects of study participation that require using a computer and providing feedback. Participants with >1 pain diagnosis or comorbid mental health diagnoses other than those already listed will not be excluded.
Potential participants will be prescreened by telephone to determine whether study eligibility criteria are met. Individuals who remain eligible after the telephone prescreen will be scheduled for a baseline session during which staff will obtain informed consent and confirm clinical eligibility through the Structured Clinical Interview for DSM-5 to assess for potential psychosis, substance use disorders (SUDs), or clinically significant suicidality. Eligible participants will complete self-report measures via an online or mailed paper survey, and after completion of the survey, they will be randomized in a 1:1 ratio into 4 randomly permuted blocks (10 per block) to either the VACT-CP condition or the WL+TAU control condition. Veterans randomized to the VACT-CP condition will receive 7 online weekly modules to be accessed using a desktop or laptop computer within a secure space at the VA Bedford Healthcare System. Veterans in the WL+TAU control group will be provided with a list of common pain resources and encouraged to connect to their local VA pain clinic if interested in pain management care. All participants will complete the 4 surveys. At the conclusion of the study, participants in the WL+TAU condition will be provided with the VACT-CP website as an optional pain management resource, but they will not be asked to use it and will not be followed as research participants. Participants will be compensated US $60 for the baseline assessment (approximately 1 hour), US $40 at the midpoint (week 3; approximately 45 minutes), US $60 at the end of treatment (week 7; approximately 1 hour), and US $40 for the week 11 (1-month follow-up; approximately 40 minutes) for a total possible compensation of US $200.
Veteran Acceptance and Commitment Therapy for Chronic Pain (VACT-CP) timeline and intervention description.
| Timeline | Module focus | Intervention components |
| Week 1 | Introduction to the VACT-CP program | The introductory module assesses the nature of the veteran’s pain, past treatments, and experience with acceptance and mindfulness. Coach Anne provides information on ACTa and assesses the veteran’s values and goals to help them set a weekly goal. |
| Week 2 | Behavioral change and triggers | This module focuses more broadly on pain psychoeducation and pain management. Veterans complete exercises on dealing with cognitive barriers with the goal of changing their own self-identified obstructions to living a meaningful life. |
| Week 3 | Acceptance and mindfulness | This module uses metaphors and a veteran narrative story to explain and explore concepts of acceptance and mindfulness, and the veteran completes an acceptance exercise linked to previously identified values. |
| Week 4 | Cognitive defusion | This module focuses on the ACT concept of cognitive defusion using psychoeducation about the nature of language and cognitive barriers to valued living. Metaphors, mindfulness, and ACT exercises are included. |
| Week 5 | Willingness | This module explains the ACT concept of willingness and discusses willingness to experience discomfort as a means to pursuing important valued living goals. The veteran creates and applies a willingness hierarchy to identify a goal for the week that embodies values-driven willingness. |
| Week 6 | Committed action | This module focuses on the ACT concept of committed action. Coach Anne helps the user to identify personal barriers to committed action and strategies for dealing with these perceived barriers. |
| Week 7 | Valued living wrap-up | The final session provides an overview of ACT processes, a review of goals achieved, and reinforces progress made during the program. This session ends with planning for the “lifelong assignment” of fully engaging in one’s life. |
| Additional modules | Mindfulness exercises module | This module introduces the topic of mindfulness and provides a series of questions to route users to use exercises that align with their goal for the mindfulness experience. This module is accessible any time after completing the first module. |
| Additional modules | Additional resources | This module provides additional information, links, and resources for care options within the VHAb for pain, psychiatric conditions, and physical health management. |
aACT: acceptance and commitment therapy.
bVHA: Veterans Health Administration.
The 7 online modules that participants will receive as weekly sessions feature Coach Anne as a digital treatment guide (
Once a module has been completed, the next week’s module opens 5 days later to allow for more flexible completion of the 7 sessions. Thus, the shortest duration over which a user can complete the VACT-CP protocol is 35 days. The system prevents the user from completing the next week’s module immediately because they must wait 5 days for the next module to open. This was incorporated to provide the user with several days to meet self-created goals, practice skills, and use other resources provided through the website as desired. Participants will be contacted via telephone at week 3 and week 5 to check in on any usability issues and potential concerns, as well as to assess for any possible risk related to mood, physical health, or suicidal ideation. Users can access the website for their entire participation time (11 weeks).
Screenshot of the Veteran Acceptance and Commitment Therapy for Chronic Pain website program.
We will use many of the same surveys from phase 2 in our phase 3 data collection, including the Patient Health Questionnaire-9, Posttraumatic Stress Disorder Checklist, Brief Pain Inventory, VR-36, Intrinsic Motivation and Perceived Usefulness Scales [
Feasibility outcomes will include information on recruitment rates, retention rates within each condition, completion rates, how often each veteran accesses the website, and any reported problems with the website. This information will be collected through open-ended survey items, website data, and through use of a semistructured post–VACT-CP qualitative interview (
The Pain Outcomes Questionnaire-Short Form [
The Chronic Pain Acceptance Questionnaire-Revised [
The Chronic Pain Values Inventory [
The Multidimensional Experiential Avoidance Questionnaire (MEAQ) [
The Client Satisfaction Questionnaire-8 [
Consistent with the recommended stage model for development of behavioral therapies, the aim of this stage IB pilot feasibility RCT is to inform future treatment development and evaluation. Given that prior investigations of ACT have reported effect sizes in the large-to-medium range, we expect that the VACT-CP intervention will also produce at least a medium treatment effect. To have a power of 0.80 to detect differences at a 2-tailed
Usability of the VACT-CP system as assessed through the SUS is the primary outcome for the RCT. Scores for those in the VACT-CP group will be aggregated and described according to these metrics, with an SUS score of >68 interpreted as above average and a score of >80 as high and reflective of a system that participants are likely to recommend to others [
Secondary exploratory analyses will describe satisfaction with the VACT-CP system and the potential impact of the intervention on treatment outcomes related to pain-related interference in daily functioning and severity (Pain Outcomes Questionnaire-Short Form), pain acceptance (Chronic Pain Acceptance Questionnaire-Revised), behavioral avoidance (MEAQ), valued living (Chronic Pain Values Inventory), and mental and physical functioning (VR-36 Mental Component Score and VR-36 Physical Component Score). On the basis of the intent-to-treat principle, all participants enrolled and successfully randomized will be included in these analyses, and the principal investigator will conduct preliminarily analyses and descriptively report on the pilot RCT outcomes of the VACT-CP intervention to inform further refinements to it. Descriptive measures (means and SDs) will be reported for all outcomes of interest. We anticipate that, for VACT-CP participants, we will observe increases in the mean scores for pain acceptance, valued living, and mental and physical functioning, as well as a decrease in pain-related interference in daily functioning and behavioral avoidance. In addition, we predict that there will be small-to-no changes in mean pain severity levels, given research suggesting that behavior interventions do not change pain levels for participants with chronic pain. Given imprecise estimations owing to the pilot’s small sample size and a lack of power, we will not report estimates of effect sizes for these specific predictions. However, we will report descriptive outcomes (means and SDs) between before and after the intervention as well as between the groups and use nonparametric testing to report changes in secondary outcomes at the individual and group levels (pain acceptance, valued living, and mental and physical functioning, as well as pain-related interference in daily functioning and behavioral avoidance).
All 3 phases of this study were approved by the institutional review board of the VA Bedford Healthcare System Research & Development Committee in Bedford, Massachusetts, United States (1598754), with initial approval granted in September 2018.