Developing an Online Therapeutic Intervention for Chronic Pain in Veterans

NCT03655132 | Completed Results

• 1 other identifier: D2814-W
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Chronic Pain

Keywords

chronic pain; veterans; ACT; online treatment

Outcome Measures

Primary Outcomes (2)

• System Usability Scale (SUS)

  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. Multiply the sum of the scores by 2.5 to obtain the overall value of system usability. SUS scores have a range of 0 to 100, with higher scores suggesting greater system usability. A SUS score above 58 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.

  Post-Intervention, at 8 weeks for VACT-CP group only

• Usability Survey

  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.

  Through study completion (pre and post), on average 8 weeks

Secondary Outcomes (6)

• Pain Outcomes Questionnaire - VA (POQ - VA)

  Through study completion (pre and post), on average 8 weeks

• The Chronic Pain Acceptance Questionnaire (CPAQ)

  Through study completion (pre and post), on average 8 weeks

• Multidimensional Experiential Avoidance Questionnaire (MEAQ)

  Through study completion (pre and post), on average 8 weeks

• The Chronic Pain Values Inventory (CPVI)

  Through study completion (pre and post), on average 8 weeks

• Pain Numeric Rating Scale

  Through study completion (pre and post), on average 8 weeks

Study Arms (2)

Waitlist Control Group

NO INTERVENTION

Veterans in the waitlist control will be provided with a list of common pain resources at the Bedford VAMC.

VACT-CP Group

EXPERIMENTAL

Veterans randomized to VACT-CP will receive 7 online-module based weekly sessions of treatment via personal computer or provided tablet with wireless accessibility at the Bedford VAMC.

Behavioral: Veteran Acceptance and Commitment Therapy for Chronic Pain

Interventions

Veteran Acceptance and Commitment Therapy for Chronic Pain BEHAVIORAL

Seven online modules based on the theoretical framework of ACT for chronic pain, provided as weekly sessions that will feature an ECA (virtual therapist) as a treatment guide. The initial module is devoted to an explanation of the treatment rationale, initial psychoeducation on pain-related symptoms, pain interference, and focal concepts of ACT, and assessment of individual pain symptoms. Modules 2-4 will focus on values clarification, acceptance and willingness, mindfulness, with an emphasis on tolerance of pain-related experiences. Modules 5-7 will continue to this focus, and incorporate goal-creation and committed action exercises. Module 8 will consolidate and provide feedback on goal-related achievements, and will focus on planning for the future.

Also known as: VACT-CP

VACT-CP Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current diagnosis of non-cancer chronic pain, defined as:
• at least one pain-related diagnosis indicated by an ICD-9 or -10 code related to either Musculoskeletal pain or Joint Problems/Osteoarthritis
• or presence of chronic pain of at least mild to moderate severity as indicated by two or more NRS pain scores of 4 at three separate VA outpatient visits in past year based on a CPRS record review;
• Has a working, high-speed wireless internet connection at home, or is willing to access sessions either at the Bedford VAMC by using a tablet in a secure space
• Competent to provide written informed consent

You may not qualify if:

• Any current or lifetime DSM-5 psychotic disorder
• Current or recent (within 1 month of study entry) DSM-5 alcohol or drug use disorder
• \[Current use of any other chronic pain-related behavioral or psychological treatment\]
• Any cognitive impairment that would interfere with study participation
• Clinically significant suicidality within the past year
• Presence of any clinical features requiring a higher level of care (inpatient or partial hospital treatment)
• Any cognitive or physical impairment that would interfere with study participation of using a tablet/computer and providing feedback

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, 01730-1114, United States

Location

Related Publications (2)

• Reilly ED, Kathawalla UK, Robins HE, Heapy AA, Hogan TP, Waring ME, Quigley KS, Drebing CE, Bickmore T, Volonte M, Kelly MM. An Online Acceptance and Mindfulness Intervention for Chronic Pain in Veterans: Development and Protocol for a Pilot Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2023 Mar 7;12:e45887. doi: 10.2196/45887.

  PMID: 36881446 BACKGROUND

• Reilly ED, Kelly MM, Grigorian HL, Waring ME, Quigley KS, Hogan TP, Heapy AA, Drebing CE, Volonte M, Kathawalla UK, Robins HE, Bernice K, Bickmore T. Virtual Coach-Guided Online Acceptance and Commitment Therapy for Chronic Pain: Pilot Feasibility Randomized Controlled Trial. JMIR Form Res. 2024 Nov 8;8:e56437. doi: 10.2196/56437.

  PMID: 39514264 RESULT

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Erin D. Reilly
• Organization: VA Bedford Healthcare System

Erin.Reilly@va.gov

781-724-4191

Study Officials

• Erin D. Reilly, PhD

  VA Bedford HealthCare System, Bedford, MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants in Phase 3 will be randomly assigned to either a wait-list control condition, or to receive the intervention of VACT-CP, including the 8 online-module based weekly sessions of treatment.

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: August 31, 2018
• Study Start: March 17, 2022
• Primary Completion: May 30, 2023
• Study Completion: October 31, 2023
• Last Updated: February 20, 2025
• Results First Posted: September 19, 2024

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)