HIV Neuropathy Clinical Trial
Official title:
Feasibility Randomized-Controlled Trial of Online Acceptance and Commitment Therapy for Painful Peripheral Neuropathy in People Living With HIV: The OPEN Feasibility Study
The current trial will explore the feasibility of a larger efficacy trial to test a newly developed form of online CBT called Acceptance and Commitment Therapy (which we have called "ACT OPEN") for people with HIV and painful peripheral neuropathy. Participants will be recruited 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 8 weeks and five months later.
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
painful peripheral neuropathy. Participants will be recruited 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 8 weeks and five months later.
The purpose of this study is to examine the feasibility of a larger trial evaluating the
impact of online ACT for people with HIV and chronic pain in their feet. Key feasibility
parameters that will be evaluated will include an estimate of the recruitment and retention
rates, treatment completion rate and satisfaction, and an estimate of the effect size of
changes in standard pain outcome measures.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT01537705 -
A Clinical Outcomes Study to Measure Reduction in Pain and Numbness During Administration of an Amino Acid Formulation in Subjects Diagnosed With Peripheral Neuropathy
|
Phase 2 | |
| Completed |
NCT03099005 -
Effect of Cannabis and Endocannabinoids on HIV Neuropathic Pain
|
Phase 2 | |
| Completed |
NCT00904202 -
A Study Of Lidocaine Patch 5% Alone, Gabapentin Alone, And Lidocaine Patch 5% And Gabapentin In Combination For The Relief Of Pain In Patients With Diverse Peripheral Neuropathic Pain Conditions
|
Phase 4 | |
| Recruiting |
NCT03855111 -
Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain
|
N/A |