Title: Acceptance and Commitment Therapy for individuals with painful HIV-related sensory neuropathy: Developing a tailored online intervention using a mixed-methods approach.
Funder: Department of Health and Social Care

Abstract: Background: The human immunodeficiency virus (HIV) remains a significant global health concern with an estimated 35 million people infected worldwide and 110,000 in the United Kingdom. Pain is one of the most common symptoms associated with HIV. Between 40% and 60% of infected individuals develop sensory neuropathies; 50% to 90% of these individuals experience severe and debilitating neuropathic pain. This pain is highly refractory and is associated with high levels of disability, psychological distress, and reduced quality of life. Research suggests that current medical interventions are ineffective for managing painful HIV-related sensory neuropathy (painful HIV-SN). There is strong evidence supporting the efficacy cognitive behavioural therapy (CBT), including Acceptance and Commitment therapy (ACT), for chronic musculoskeletal pain. There is also growing evidence that these therapies can be delivered cost-effectively over the Internet. However, there is a dearth of comparable research for patients with painful HIV-SN. At present, there are no data upon which to implement psychologically-based interventions for patients with painful HIV-SN. Previous research suggests that issues related to substance abuse and stigmatization might be important factors that influence treatment access and engagement among individuals with HIV. However, such factors are not routinely considered in ACT treatments for chronic musculoskeletal pain. Thus, research is needed to comprehensively understand the unique psychological challenges of individuals with painful HIV-SN and how these barriers might be addressed within a psychologically-based pain management intervention. Adequate pain management is now internationally recognized as a fundamental human right; therefore, the need to develop more effective treatments for patients with painful HIV-SN is clear. Aims: This program of research aims to develop a new online ACT-based treatment to improve health and quality of life of patients with painful HIV-SN. This research will identify the unique psychological challenges associated with painful HIV-SN and will tailor the ACT intervention to specifically address these. Lastly, the research will investigate whether a tailored online version of ACT can be feasibly delivered to individuals with HIV-CNP. Plan of Investigation: The proposed project is a mixed-methods programme of research comprising three studies. First, a systematic review and meta-analysis of existing evidence investigating the impact of psychological factors on HIV-related pain, disability, and quality of life will be conducted. Next, in-depth, qualitative interviews will be conducted with 30-50 individuals with painful HIV-SN to examine the specific needs this group for the online ACT-based. The resulting interview responses will be analysed thematically. The final study will develop and tailor the ACT online treatment protocol on the basis of findings from the systematic review and qualitative study to address the unique psychological challenges of individuals with painful HIV-SN. A feasibility study will be conducted to determine important parameters for a future large scale randomized controlled trial can be undertaken and to solicit patient feedback to make further treatment refinements. Patient and public involvement will be solicited throughout the research project. Potential Benefits: The proposed project will lead to the creation of a new treatment for patients with painful HIV-SN for which more effective treatments are urgently needed. If successful, this project will provide the basis for a randomized controlled-trial with a focus on cost-effectiveness; ultimately, this may support NHS uptake of the intervention. Additionally, the development of a new treatment for painful HIV-SN may serve as the basis for broader treatment improvements for individuals with other neuropathic pain conditions for which evidence of treatment efficacy is also poor. Investigation of barriers to treatment access and adherence in individuals with painful HIV-SN may likewise improve interventions for individuals in other vulnerable minority groups that face inequalities in pain management.

Lay abstract: Background to the research: The human immunodeficiency virus (HIV) is a major health problem in the United Kingdom and around the world. Pain is one of the most common symptoms associated with HIV. This pain is very difficult to treat and there is poor evidence that current medications are helpful for managing this pain. Additionally, individuals with HIV-related pain have high levels of disability, psychological distress, and poor quality of life.Psychological treatments, such as cognitive behaviour therapy (CBT), have been shown to help improve quality of life for individuals with chronic musculoskeletal pain. More recently, there have been efforts to provide these treatments over the Internet to increase the number of individuals who may access them. However, it is not presently known whether similar online psychological treatments may be helpful for individuals with pain related to HIV. There are a number of potential challenges in creating a psychological treatment, such as CBT, for managing pain in individuals with HIV; these challenges include high rates of substance abuse, stigmatization, and mental health problems in this population. Failure to consider these issues in treatment might contribute to high dropout rates, which limit the potential benefits of treatment. Considering the lack of adequate pain treatment and the psychological and social difficulties experienced by many individuals with HIV, the need to develop more effective treatments is clear. Aims: This research will develop a psychological treatment to improve health and quality of life among individuals with pain related to HIV. This proposed treatment will be delivered over the Internet and will be based on a form of CBT called Acceptance and Commitment Therapy (ACT). Within this general approach to treatment, the research aims to identify the specific psychological challenges of individuals with pain related to HIV so that the treatment can be tailored specifically to the needs of this group. It is expected that tailoring the treatment in this way will improve the usability and efficacy of the treatment. The research also aims to provide a preliminary test of the feasibility of this new treatment, which will provide the basis for a larger scale study of the efficacy of the treatment in the future. Design and methods used: The project will use a range of methods to develop the new treatment. First, a systematic review of the existing research will be conducted to identify the unique psychological challenges associated with HIV-related pain. Next, 30-50 individuals with HIV-related pain will be interviewed to gain an in-depth understanding of their specific needs for a new online ACT-based pain management intervention. Finally, the online ACT treatment content and delivery platform will be developed and tested. Briefly, ACT helps people to stop struggling with pain when this struggling simply does not work for them. ACT also helps individuals to clarify their values and goals and to take steps toward achieving them. In previous studies, people with chronic pain (not related to HIV) who participated in this treatment showed improvements in their physical and social activities, mood, and reduced needs for further treatments. Findings from the systematic review and the in-depth interviews will be used to tailor the online ACT treatment approach to the specific needs of individuals with HIV-related pain. Following development of the treatment, a small feasibility study will be undertaken to determine whether the treatment can be delivered successfully. Approximately 70 individuals with HIV-related pain will be assigned to receive their medical treatment as usual plus the new ACT online treatment, or their medical treatment as usual only. This study will help us determine participants' satisfaction with the new treatment. Participant feedback from this study will be used to make further treatment improvements. Patient and public involvement: The input from one patient representative was incorporated into this proposal. Patient and public involvement will be incorporated throughout the research, including patient input into study documents and treatment materials, healthcare providers' input into the treatment, and the ongoing involvement of two patient representatives that will provide input on all aspects of the research programme. Dissemination: The results of the research will be prepared for scientific publication and for presentation and scientific conferences. A short video describing the research and the new treatment will be created and shown to patients and clinicians at several research events in London. The new intervention will ultimately be tested in a larger study to determine its efficacy. If future research supports the efficacy of the new treatment the treatment would be made available for use within the NHS.

Research activity codes: 5.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: INFECTION