OPEN Study: Pain Management Treatment Needs Interviews

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

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.

Study Overview

• Status: Completed
• Conditions: HIV; Peripheral Neuropathy

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 9RT
    • King's College London
  • London, United Kingdom, SW10 9NH
    • Chelsea & Westminster Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People with HIV and painful peripheral neuropathy. We will purposively sample men, women, ethnic minorities, and people who use recreational drugs .

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Completed a Semi-Structure Interview	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.	Day 1

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: Imperial College London; University College, London; Chelsea and Westminster NHS Foundation Trust
• Investigators: Principal Investigator: Whitney Scott, PhD, King's College London

Publications and helpful links

General Publications

• Scott W, Garcia Calderon Mendoza Del Solar M, Kemp H, McCracken LM, C de C Williams A, Rice ASC. A qualitative study of the experience and impact of neuropathic pain in people living with HIV. Pain. 2020 May;161(5):970-978. doi: 10.1097/j.pain.0000000000001783.

Helpful Links

• Published peer-reviewed paper

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): July 31, 2017

Study Registration Dates

• First Submitted: November 18, 2016
• First Submitted That Met QC Criteria: November 21, 2016
• First Posted (Estimate): November 23, 2016

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: HIV; Chronic Pain; Peripheral Neuropathy; Qualitative Research
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: 205949

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No