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Randomized Controlled Trial
. 2021 Aug;25(7):1493-1507.
doi: 10.1002/ejp.1762. Epub 2021 Mar 26.

Feasibility randomized-controlled trial of online acceptance and commitment therapy for painful peripheral neuropathy in people living with HIV: The OPEN study

Whitney Scott  1   2 , Beth J Guildford  3 , James Badenoch  1 , Elizabeth Driscoll  2 , Joseph Chilcot  1 , Sam Norton  1 , Harriet I Kemp  4 , Ming J Lee  5 , Julianne Lwanga  5 , Marta Boffito  6 , Graeme Moyle  6 , Frank A Post  7 , Lucy Campbell  7 , Jo Josh  8 , Paul Clift  8 , Amanda C de C Williams  9 , Andrew Sc Rice  4 , Lance M McCracken  10
Affiliations
Randomized Controlled Trial

Feasibility randomized-controlled trial of online acceptance and commitment therapy for painful peripheral neuropathy in people living with HIV: The OPEN study

Whitney Scott et al. Eur J Pain. 2021 Aug.

Abstract

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).

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