OPEN Study: Pain Management Treatment Needs Interviews

Presently, there are few options for medically managing HIV-related painful peripheral sensory neuropathy (HIV-SN). Psychological treatments, including Cognitive Behavioural Therapy (CBT), represent a potentially viable addition to the treatment of painful HIV-SN. However, there is a scarcity of research on psychological treatment approaches for pain management in people with HIV. This study will use in-depth semi-structured interviews to examine the needs of people with painful HIV-SN for a psychologically-based pain management treatment that may be delivered over the Internet. Interview questions will examine participants' needs in terms of treatment content and delivery format. Men and women, ethnic minorities, and people who use recreational drugs will be sampled to ensure that interview responses reflect the views of people most commonly suffering from this condition. Approximately 30 people will be recruited for the study. The interviews will be audio recorded, transcribed verbatim, and coded to identify themes. The interview responses will be used to develop and tailor a version of CBT for people with painful HIV-SN. It is hoped that tailoring the treatment based on the qualitative interview responses will increase the acceptability of the treatment and will improve treatment adherence rates for a future study.

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Key information

Conditions

HIV Chronic Pain Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Peripheral Neuropathy Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chelsea & Westminster Hospital NHS Foundation Trust, London, United Kingdom

About this study

This report is independent research supported by the National Institute for Health Research (NIHR Post Doctoral Fellowship, Dr Whitney Scott, PDF-2015-08-059). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults aged 18 years or older.
Living with HIV.
A positive screen for peripheral sensory neuropathy, as indicated by: presence of self-reported bilateral foot pain and/or numbness in a symmetrical distribution.
Positive screen for symptoms of neuropathic pain in the feet, as indicated by a score of greater than or equal to 3 on the patient reported outcomes section of the Neuropathic Pain Interview.
Pain in the feet present most days for at least 3 months.
Average pain intensity of greater than or equal to 4/10.
Average interference of pain with daily activities is greater than or equal to 4/10.

Exclusion criteria

Presence of excessive alcohol consumption, hypothyroidism, vitamin B12 deficiency, diabetes, exposure to isoniazid or chemotherapy drug treatment, or a known history of a neuropathy due to a cause other than HIV or antiretroviral treatment
Unable to conduct interview in English.
Current diagnosis of dementia or learning disability.
Unwilling to provide written informed consent.

Treatment and study plan

Primary outcomes

Number of Participants Who Completed a Semi-Structure Interview

Time frame: Day 1

Semi-structured interview performed at one occasion where the patient describes his/her experience living with painful peripheral neuropathy and his/her thoughts about a psychological treatment for managing pain.

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

Chelsea and Westminster NHS Foundation Trust
Imperial College London
University College, London

Registry information

Official study title

Online Psychological Treatment for People With Painful HIV-related Peripheral Neuropathy (OPEN Study): Qualitative Investigation of Treatment Needs

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Nov 23, 2016
Registry last updated: Jan 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed