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NCT03655132

Developing an Online Therapeutic Intervention for Chronic Pain in Veterans

Completed NA Results posted Last updated 20 February 2025
What this trial tests

NA trial testing Veteran Acceptance and Commitment Therapy for Chronic Pain in Chronic Pain in 42 participants. Completed in 31 October 2023.

Timeline
17 March 2022
Primary endpoint
30 May 2023
31 October 2023

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment42
Start date17 March 2022
Primary completion30 May 2023
Estimated completion31 October 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Chronic Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

System Usability Scale (SUS) Primary · Post-Intervention, at 8 weeks for VACT-CP group only

The SUS is a 10-item measure, scored on a 5-point Likert scale from Strongly Disagree (1) to Strongly Agree (5), that assesses human-computer interaction. 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. To calculate the SUS score, first sum the score contributions from each item. Each item's score contribution will range from 0 to 4. For items 1,3,5,7,and 9 the score contribution is the scale position minus 1. For items 2, 4, 6, 8, and 10, the contribution is 5 minus the scale position.

GroupValue95% CI
VACT-CP Group79.6± 12.8
Usability Survey Primary · Through study completion (pre and post), on average 8 weeks

The usability survey items are drawn from a questionnaire developed by Wilson and Lankton (2004) to measure a range of health information technology areas. Each item is scored on a 5 point Likert scale where 1 = strongly disagree and 5 = strongly agree, with an average calculated for each scale ranging from 1 to 5. For the current study, 3 subscales were used: Intrinsic Motivation Scale, Perceived Ease of Use Scale, and Perceived Usefulness: For each scale respectively, higher scores indicating greater levels of motivation, perceived ease of use, and perceived usefulness.

Baseline Perceived Ease of Use Subscale Score
GroupValue95% CI
VACT-CP Group4.08± .61
Post Perceived Ease of Use Subscale Score
GroupValue95% CI
VACT-CP Group3.96± 1.05
Baseline Intrinsic Motivation Subscale Score
GroupValue95% CI
VACT-CP Group3.78± .77
Post- Intrinsic Motivation Subscale Score
GroupValue95% CI
VACT-CP Group3.74± 1.04
Baseline Perceived Usefulness Subscale Score
GroupValue95% CI
VACT-CP Group3.625± .68
Post- Perceived Usefulness Subscale Score
GroupValue95% CI
VACT-CP Group3.66± .10
Pain Outcomes Questionnaire - VA (POQ - VA) Secondary · Through study completion (pre and post), on average 8 weeks

A 19-item inventory that assesses patient's ability to engage in functional activities related to daily living that may be impacted by pain interference, with the scale ranging from 0 (not at all) to 10 (all the time). The scale provides a total score based on the summation of 6 subscales: Pain (1 item, range 0 to 10); Mobility (4 items; range 0 to 40); ADL (4 items, range 0 to 40); Vitality (3 items, range 0 to 30); Negative Affect (5 items, range 0 to 50); and Fear (2 items, range 0 to 20). Scores range from 0 to 190, with higher scores on the POQ-VA indicate higher levels of pain interferin

Baseline POQ total score
GroupValue95% CI
Waitlist Control Group8869.5 – 102
VACT-CP Group9376.00 – 108.5
Post-Intervention POQ total score
GroupValue95% CI
Waitlist Control Group8373.75 – 96
VACT-CP Group92.570.5 – 108.75
The Chronic Pain Acceptance Questionnaire (CPAQ) Secondary · Through study completion (pre and post), on average 8 weeks

A 20-item survey measuring recognition of pain as not negating the ability to live valued, meaningful life. The survey also includes two subscales: the Activity Engagement subscale (11 items, range 0 to 77) and Pain Willingness (9 items, range 0 to 63). To score the total CPAQ, add the items for Activity Engagement and Pain Willingness together. Scores range from 0 to 140, with higher scores indicate higher levels of pain acceptance.

Baseline CPAQ total score
GroupValue95% CI
Waitlist Control Group8069.3 – 91
VACT-CP Group6658 – 81.8
Post-CPAQ total score
GroupValue95% CI
Waitlist Control Group8270.5 – 90
VACT-CP Group8067.3 – 85.5
Multidimensional Experiential Avoidance Questionnaire (MEAQ) Secondary · Through study completion (pre and post), on average 8 weeks

A 62-item self-report measure of experiential avoidance, including subscales on Behavioral Avoidance (11 items, range 11 to 66), Distress Aversion (13 items, range 13 to 78), Procrastination (7 items, range 7 to 42), Distraction \& Suppression (7 items, range 7 to 42), Repression \& Denial (13 items, range 13 to 78), and Distress Endurance (11 items, range 11 to 66). The scale for all items ranges from 1 (strong disagree) to 6 (strongly agree). Greater scores within each subscale indicate greater levels of the named construct, e.g. behavioral avoidance. The current study utilized the behaviora

Baseline MEAQ-Behavioral Avoidance
GroupValue95% CI
Waitlist Control Group3224 – 42.25
VACT-CP Group36.526.5 – 45
Post- MEAQ Behavioral Avoidance
GroupValue95% CI
Waitlist Control Group32.527.5 – 42.25
VACT-CP Group39.536 – 44.5
The Chronic Pain Values Inventory (CPVI) Secondary · Through study completion (pre and post), on average 8 weeks

A 12-item self-report measure of the extent to which one 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. Respondents rate each item on a scale from 0 (not at all important /successful) to 5 (extremely important / successful). Two primary scores are obtained in scoring the CPVI - an Importance subscale (6 items, range 0 to 6) and a Success subscale (6 items, range 0 to 6). Using these two scales,

Baseline CPVI-D score
GroupValue95% CI
Waitlist Control Group1.8.8 – 2.7
VACT-CP Group1.81 – 2.5
Post- CPVI-D score
GroupValue95% CI
Waitlist Control Group1.8.8 – 2.4
VACT-CP Group1.5.7 – 2.6
Pain Numeric Rating Scale Secondary · Through study completion (pre and post), on average 8 weeks

The Veteran will be asked to rate their current level of pain using a 11-item pain intensity scale from 0 (no pain at all) to 10 (extreme pain). This is a single-item score, which ranges from 0 to 10, with higher scores indicating greater levels of reported pain.

Baseline Pain NRS Score
GroupValue95% CI
Waitlist Control Group76 – 8
VACT-CP Group7.56 – 8.8
Post- Pain NRS Score
GroupValue95% CI
Waitlist Control Group7.55 – 8.3
VACT-CP Group75.3 – 9
Client Satisfaction Questionnaire-8 (CSQ-8) Secondary · Post-intervention measure (average 8 weeks after baseline)

This 8-item scale produces a single total score, with higher scores indicating greater levels of global satisfaction, perceived quality, and effectiveness of a treatment. Individual items are rated on a scale from 1 (low satisfaction) to 4 (high satisfaction), with the total CSQ-8 score obtained by adding the items answered together, with scores ranging from 8 to 32 and higher scores indicating greater levels of satisfaction with a treatment program.

GroupValue95% CI
VACT-CP Group23.7± 5.2

Sponsor's own description

Chronic pain is a serious concern that disproportionately affects Veterans compared to the general public; Veterans are diagnosed with chronic pain 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. 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. In order to improve Veterans' quality of life, it is important to develop and evaluate innovative, accessible, evidence-based interventions for managing chronic pain. One approach with over twenty years of efficacious treatment for chronic pain is Acceptance and Commitment Therapy (ACT) for Chronic Pain (ACT-CP). ACT is a well-established 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. ACT- CP is associated with substantial improvements in social/work functioning and decreased pain-related medical visits, as long as three years following treatment. For adults with chronic pain, technology-assisted ACT treatment leads to reduced self-reported pain levels and improved health via changes in value-aligned behaviors and mindfulness. The use of interactive technology-assisted ACT treatment is acceptable and efficacious; however, no ACT for chronic pain online treatment exists for Veterans. The investigators will thus complete a three-phase development, intervention usability and feasibility, and randomized controlled trial (RCT) pilot to create Veteran ACT intervention for chronic pain (VACT-CP). VACT-CP will utilize a personalized, social interface to address pain-related distress and functional difficulties of chronic pain (e.g., avoidance, reactivity), using an online Embodied Conversational Agent (ECA) that will walk Veterans through eight weeks of treatment. Studies suggest that the use of such ECAs can increase online-treatment motivation and feedback, resulting in increased treatment compliance and utilization, physical functioning (e.g., increased physical activity and diet fidelity), and client-goal achievement. The primary outcomes for this project will be to (1) develop the VACT-CP user system using feedback from mental health and other clinical professionals treating chronic pain (n = 10), (2) pilot the usability and feasibility of the through iterative usability development and Veteran feedback (n = 12 - 15), and (3) explore the impact of the VACT-CP system in terms of user-experience, functional outcome improvement, and quality of life measures (n = 40).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Psychological therapies delivered remotely for the management of chronic pain (excluding headache) in adults.
    Rosser BA, Fisher E, Janjua S, Eccleston C, et al · · 2023 · cited 13× · PMID 37643992 · DOI 10.1002/14651858.cd013863.pub2
  2. An Online Acceptance and Mindfulness Intervention for Chronic Pain in Veterans: Development and Protocol for a Pilot Feasibility Randomized Controlled Trial.
    Reilly ED, Kathawalla UK, Robins HE, Heapy AA, et al · · 2023 · cited 3× · PMID 36881446 · DOI 10.2196/45887
  3. Virtual Coach-Guided Online Acceptance and Commitment Therapy for Chronic Pain: Pilot Feasibility Randomized Controlled Trial.
    Reilly ED, Kelly MM, Grigorian HL, Waring ME, et al · · 2024 · cited 2× · PMID 39514264 · DOI 10.2196/56437

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