An Online Acceptance and Mindfulness Intervention for Chronic Pain in Veterans: Development and Protocol for a Pilot Feasibility Randomized Controlled Trial

Abstract

Background In the veteran community, chronic pain is particularly prevalent and often debilitating. Until recently, veterans with chronic pain were offered primarily pharmacological intervention options, which rarely suffice and can also have negative health consequences. To better address chronic pain in veterans, the Veterans Health Administration has invested in novel, nonpharmacological behavior interventions that target both pain management and chronic pain–related functional issues. One approach, acceptance and commitment therapy (ACT) for chronic pain, is supported by decades of efficacy evidence for improving pain outcomes; however, ACT can be difficult to obtain owing to issues such as a lack of trained therapists or veterans having difficulty committing to the time and resources needed for the full clinician-led ACT protocol. Given the strong ACT evidence base combined with access limitations, we set out to develop and evaluate Veteran ACT for Chronic Pain (VACT-CP), an online program guided by an embodied conversational agent to improve pain management and functioning. Objective The aims of this study are to develop, iteratively refine, and then conduct a pilot feasibility randomized controlled trial (RCT) of a VACT-CP group (n=20) versus a waitlist and treatment-as-usual control group (n=20). Methods This research project includes 3 phases. In phase 1, our research team consulted with pain and virtual care experts, developed the preliminary VACT-CP online program, and conducted interviews with providers to obtain their feedback on the intervention. In phase 2, we incorporated feedback from phase 1 into the VACT-CP program and completed initial usability testing with veterans with chronic pain. In phase 3, we are conducting a small pilot feasibility RCT, with the primary outcome being assessment of usability of the VACT-CP system. Results This study is currently in phase 3; recruitment for the RCT began in April 2022 and is expected to continue through April 2023. Data collection is expected to be completed by October 2023, with full data analysis completed by late 2023. Conclusions The findings from this research project will provide information on the usability of the VACT-CP intervention, as well as secondary outcomes related to treatment satisfaction, pain outcomes (pain-related daily functioning and pain severity), ACT processes (pain acceptance, behavioral avoidance, and valued living), and mental and physical functioning. Trial Registration ClinicalTrials.gov NCT03655132; https://clinicaltrials.gov/ct2/show/NCT03655132 International Registered Report Identifier (IRRID) DERR1-10.2196/45887

Embodied Conversational Agents for Chronic Diseases: Scoping Review

“…Multimedia Appendix 4 [ 10 , 11 , 26 - 57 ] presents a summary of the studies included in this review. The characteristics of the included studies are presented in detail in Table 1 .…”

“…Among the studies that reported a study design, mixed method studies (8/36, 22%) [ 10 , 28 , 39 - 44 ] and pilot studies (8/36, 22%) [ 31 , 34 , 38 , 45 - 48 ] were the most commonly used study designs, followed by qualitative studies (6/36, 17%) [ 11 , 26 , 35 , 49 - 51 ], randomized controlled trials (5/36, 14%) [ 32 , 37 , 52 - 54 ], ongoing trials (4/36, 11%) [ 33 , 55 - 57 ], quasiexperimental designs (2/36, 6%) [ 30 ], longitudinal study (1/36, 3%) [ 29 ], single-group nonrandomized trial (1/36, 3%) [ 36 ], and pre- and posttest design (1/36, 3%) [ 27 ]. Of the 36 studies, 30 (83%) were conducted on patients (15/36, 42%) [ 10 , 26 , 32 , 34 - 37 , 40 , 42 , 47 , 52 , 54 - 57 ] or healthy individuals (15/36, 42%) [ 11 , 27 , 29 - 31 , 44 - 46 , 48 - 51 , 53 ] and 6 (17%) [ 28 , 33 , 38 , 39 , 41 , 43 ] on stakeholders such as homecare providers or experts. The mean age of the target population across studies was >40 years, except for 19% (7/36) of the studies [ 30 , 33 , 35 , 47 , 53 , 57 ].…”

“…Of the 36 studies, 30 (83%) were conducted on patients (15/36, 42%) [ 10 , 26 , 32 , 34 - 37 , 40 , 42 , 47 , 52 , 54 - 57 ] or healthy individuals (15/36, 42%) [ 11 , 27 , 29 - 31 , 44 - 46 , 48 - 51 , 53 ] and 6 (17%) [ 28 , 33 , 38 , 39 , 41 , 43 ] on stakeholders such as homecare providers or experts. The mean age of the target population across studies was >40 years, except for 19% (7/36) of the studies [ 30 , 33 , 35 , 47 , 53 , 57 ].…”

“…Of the 36 studies, 8 (22%) addressed atrial fibrillation [ 34 , 52 , 55 , 56 ] and type 2 diabetes [ 10 , 26 , 37 , 39 ]. Other conditions included dementia (2/36, 6%) [ 41 , 42 ], obesity (1/36, 3%) [ 32 ], Parkinson disease (1/36, 3%) [ 36 ], sleep apnea syndrome (1/36, 3%) [ 38 ], spinal cord injury (1/36, 3%) [ 35 ], and chronic pain (3/36, 8%) [ 47 , 54 , 57 ]. One study focused on 2 diseases [ 40 ].…”

“…The goals of the ECA-led interventions varied, with 31% (11/36) of the studies aiming to promote self-management [ 10 , 26 , 33 - 35 , 37 , 39 , 40 , 52 , 55 , 56 ], including activities such as daily walking, medication taking, healthy eating, monitoring symptoms, and interaction management. ECAs were also used for mental therapy (3/36, 8%) [ 47 , 54 , 57 ], genetic counseling (3/36, 8%) [ 30 , 53 ], assisted living (2/36, 6%) [ 41 , 42 ], diagnosis (1/36, 3%) [ 38 ], and education (1/36, 3%) [ 43 ]. Of the 36 studies, 2 (6%) [ 32 , 36 ] used ECAs to promote exercise.…”