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

Whitney Scott, Beth J. Guildford, James Badenoch, Elizabeth Driscoll, Joseph Chilcot, Sam Norton, Harriet. I Kemp, Ming. J Lee, Julianne Lwanga, Marta Boffito, Graeme Moyle, Frank. A Post, Lucy Campbell, Jo Josh, Paul Clift, Amanda C de C Williams, Andrew Rice, Lance. M McCracken

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9 Citations (Scopus)
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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).

Original languageEnglish
Pages (from-to)1493-1507
Number of pages15
Issue number7
Early online date26 Mar 2021
Publication statusPublished - 1 Aug 2021


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