OPEN Feasibility Study
Research type
Research Study
Full title
Feasibility Randomized-Controlled Trial of Online Acceptance and Commitment Therapy for Painful Peripheral Neuropathy in People Living with HIV: The OPEN Feasibility Study
IRAS ID
236730
Contact name
Whitney Scott
Contact email
Sponsor organisation
King's College London; Vice President & Vice Principal (Research)
Duration of Study in the UK
1 years, 6 months, 31 days
Research summary
The human immunodeficiency virus (HIV) is a major health problem in the United Kingdom and worldwide. Neuropathic pain in the feet related to peripheral neuropathy is one of the most common symptoms associated with HIV. This pain is difficult to treat and medications are not effective. Chronic pain in people with HIV is related to higher levels of disability and poor quality of life.
Psychological treatments like cognitive behaviour therapy (CBT) can improve quality of life for people with chronic pain in general (not HIV-related), and there have been efforts to provide more accessible versions of CBT over the Internet. However, it is not known whether Internet-based CBT is helpful for people with HIV and chronic pain.
The current trial will explore the feasibility of a newly developed form of online CBT called Acceptance and Commitment Therapy (which we have called “ACT OPEN”) for people with HIV and chronic pain in their feet. Participants will be recruited primarily from HIV clinics in London, UK. Participants will be randomly chosen to receive the new ACT OPEN treatment right away or after waiting for 5 months. The treatment lasts for 8 weeks. Participants will complete self-report questionnaires to assess pain, functioning, and mood at the beginning of the study and two and five months later.
We are interested in determining how well we can recruit participants and keep them in the trial, whether participants complete the new treatment as intended, and their satisfaction with the treatment. We are also interested in estimating how well participants who receive the new treatment immediately are functioning compared to those who receive the treatment following a waiting period. Results from this study will help us determine whether a larger study to test whether the new treatment works is feasible and to determine the procedures for that study.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
18/LO/0559
Date of REC Opinion
26 Apr 2018
REC opinion
Further Information Favourable Opinion