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Developing an Online Therapeutic Intervention for Chronic Pain in Veterans

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ClinicalTrials.gov Identifier: NCT03655132
Recruitment Status : Not yet recruiting
First Posted : August 31, 2018
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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 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 RCT pilot to create a virtual ACT intervention for chronic pain (VACT-CP) for Veterans. 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).


Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: Veteran Acceptance and Commitment Therapy for Chronic Pain Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Developing an Online Therapeutic Intervention for Chronic Pain in Veterans
Estimated Study Start Date : November 2, 2020
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
No Intervention: Waitlist Control Group
Veterans in the waitlist control will be provided with a list of common pain resources at the Bedford VAMC.
Experimental: VACT-CP Group
Veterans randomized to VACT-CP will receive 8 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
Eight 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.
Other Name: VACT-CP




Primary Outcome Measures :
  1. System Usability Scale (SUS) [ Time Frame: Post-Intervention, at 8 weeks ]
    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.

  2. Usability Survey [ Time Frame: 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 7 point Likert scale where 1 = strongly disagree and 7 = strongly agree. There are 8 subscales: 1. Satisfaction with Medical Care Scale (3 items, range 3 - 21); 2. Health Knowledge Scale (2 items, range 2 to 14); 3. Internet Dependence Scale (4 items, range 4 to 28); 4. Information-seeking Preference Scale (4 items, range 4 to 28); 5. Intrinsic Motivation Scale (3 items, range 3 to 21); 6. Perceived Ease of Use Scale (3 items, range 3 to 21); 7. Perceived Usefulness: Extrinsic Motivation Scale (3 items, range 3 to 21); 8. Behavioral Intention to Use E-health Scale (2 items, range 2 - 14). For each scale, items are summed, with higher score indicating greater levels of satisfaction, knowledge, dependence, information preference, motivation, ease of use, usefulness, and intention to use the system.


Secondary Outcome Measures :
  1. Pain Outcomes Questionnaire - VA (POQ - VA) [ Time Frame: 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). Higher scores on the POQ-VA indicate higher levels of pain interfering with quality of life.

  2. The Chronic Pain Acceptance Questionnaire (CPAQ) [ Time Frame: 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 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 CPAQ, add the items for Activity Engagement and Pain Willingness to obtain a score for each factor. To obtain the total score, add the scores for each factor together. Higher scores indicate higher levels of acceptance.

  3. Multidimensional Experiential Avoidance Questionnaire (MEAQ) [ Time Frame: 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. A total score can be obtained with the following calculation: Behavioral Avoidance + Distress Aversion + Procrastination + Distraction & Suppression + Repression & Denial + (77 - Distress Endurance).

  4. The Chronic Pain Values Inventory (CPVI) [ Time Frame: Through study completion (pre and post), on average 8 weeks ]
    A 12-item self-report measure of the extent to which the patient 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 are asked to 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 scale, two scores are calculated; The first is a mean success rating, taken as the average of the 6 success ratings (range 1 to 6). The second score is a mean discrepancy rating, taken as the mean of the differences between importance and success (range 0 to 6), with higher scores indicating greater discrepancy between importance and success.

  5. Pain Numeric Rating Scale [ Time Frame: 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.

  6. Client Satisfaction Questionnaire-8 (CSQ-8) [ Time Frame: Through study completion (pre and post), on average 8 weeks ]
    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 averaging the items answered (range 0 to 4).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03655132


Contacts
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Contact: Erin D Reilly, PhD (781) 687-4191 Erin.Reilly@va.gov

Locations
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United States, Massachusetts
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA Not yet recruiting
Bedford, Massachusetts, United States, 01730
Contact: Erin D Reilly, PhD    781-687-4191    Erin.Reilly@va.gov   
Principal Investigator: Erin D. Reilly, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Erin D. Reilly, PhD Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03655132     History of Changes
Other Study ID Numbers: D2814-W
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
chronic pain
veterans
ACT
online treatment

Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms