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

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

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.