Feasibility Randomized-Controlled Trial of Online Acceptance and Commitment Therapy for Painful Peripheral Neuropathy in People Living with HIV: The OPEN Study

TY - JOUR

T1 - Feasibility Randomized-Controlled Trial of Online Acceptance and Commitment Therapy for Painful Peripheral Neuropathy in People Living with HIV: The OPEN Study

AU - Scott, Whitney

AU - Guildford, Beth J.

AU - Badenoch, James

AU - Driscoll, Elizabeth

AU - Chilcot, Joseph

AU - Norton, Sam

AU - Kemp, Harriet. I

AU - Lee, Ming. J

AU - Lwanga, Julianne

AU - Boffito, Marta

AU - Moyle, Graeme

AU - Post, Frank. A

AU - Campbell, Lucy

AU - Josh, Jo

AU - Clift, Paul

AU - C de C Williams, Amanda

AU - Rice, Andrew

AU - McCracken, Lance. M

N1 - Funding Information: This research was independent work supported by the National Institute for Health Research (NIHR Postdoctoral Fellowship, Dr Whitney Scott, PDF-2015-08-059). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and Social Care. The associated HIV-POGO Study was funded by the European Commission, NeuroPain FP7 Grant EC FP7 (#HEALTH F2-2013-602891). We thank Paul Decle for providing feedback on study procedures. We thank the participants for their time and willingness. Publisher Copyright: © 2021 The Authors. European Journal of Pain published by John Wiley & Sons Ltd on behalf of European Pain Federation - EFIC ® Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

PY - 2021/8/1

Y1 - 2021/8/1

N2 - Background: Neuropathic pain negatively affects quality of life among people living with HIV (PLWH). This study examined the feasibility of conducting a full-scale randomized-controlled trial of online acceptance and commitment therapy (“ACT OPEN”) for neuropathic pain in PLWH. Methods: Using a parallel-groups design, thirty-eight participants were randomized to ACT OPEN or a waitlist control (2:1). Participants completed standard self-report outcome measures at baseline, and two- and five-months post-randomization. Participants were aware of their allocation, but assessment was blinded. Results: Twenty-five participants were randomized to ACT OPEN and 13 to the control (of 133 referrals). ACT OPEN completion was 69% and two-month trial retention was 82%. Treatment credibility and satisfaction scores for ACT OPEN were comparable to scores reported in previous trials of cognitive-behavioural treatments for pain. Four adverse events were reported during the study, including one serious adverse event; all of these were unrelated to the research procedures. Small to moderate effects and 95% confidence intervals suggest that the true effect may favour ACT OPEN for improvements in pain intensity/interference and depression. Conclusions: A full-scale RCT of online ACT for pain management in PLWH may be feasible with refinements to trial design to facilitate recruitment. Significance: Research on pain management in people living with HIV has primarily focused on pharmacological treatments with limited success. This is the first study to show the potential feasibility of a psychological treatment based on acceptance and commitment therapy delivered online and tailored for pain management in people with HIV (“ACT OPEN”). ACT OPEN may be a promising treatment in this population and further evaluation in a full-scale randomized-controlled trial appears warranted. Trial Registration: The trial was registered (clinicaltrials.gov; NCT03584412).

AB - Background: Neuropathic pain negatively affects quality of life among people living with HIV (PLWH). This study examined the feasibility of conducting a full-scale randomized-controlled trial of online acceptance and commitment therapy (“ACT OPEN”) for neuropathic pain in PLWH. Methods: Using a parallel-groups design, thirty-eight participants were randomized to ACT OPEN or a waitlist control (2:1). Participants completed standard self-report outcome measures at baseline, and two- and five-months post-randomization. Participants were aware of their allocation, but assessment was blinded. Results: Twenty-five participants were randomized to ACT OPEN and 13 to the control (of 133 referrals). ACT OPEN completion was 69% and two-month trial retention was 82%. Treatment credibility and satisfaction scores for ACT OPEN were comparable to scores reported in previous trials of cognitive-behavioural treatments for pain. Four adverse events were reported during the study, including one serious adverse event; all of these were unrelated to the research procedures. Small to moderate effects and 95% confidence intervals suggest that the true effect may favour ACT OPEN for improvements in pain intensity/interference and depression. Conclusions: A full-scale RCT of online ACT for pain management in PLWH may be feasible with refinements to trial design to facilitate recruitment. Significance: Research on pain management in people living with HIV has primarily focused on pharmacological treatments with limited success. This is the first study to show the potential feasibility of a psychological treatment based on acceptance and commitment therapy delivered online and tailored for pain management in people with HIV (“ACT OPEN”). ACT OPEN may be a promising treatment in this population and further evaluation in a full-scale randomized-controlled trial appears warranted. Trial Registration: The trial was registered (clinicaltrials.gov; NCT03584412).

UR - http://www.scopus.com/inward/record.url?scp=85103281125&partnerID=8YFLogxK

U2 - 10.1002/ejp.1762

DO - 10.1002/ejp.1762

M3 - Article

SN - 1090-3801

VL - 25

SP - 1493

EP - 1507

JO - EUROPEAN JOURNAL OF PAIN

JF - EUROPEAN JOURNAL OF PAIN

IS - 7

ER -