OPEN Study: Pain Management Treatment Needs Interviews

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02972606
• Other study ID #: 205949
• Status: Completed
• Start date: November 2016
• Est. completion date: July 31, 2017

Study information

• Verified date: September 2016
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Locations

Country	Name	City	State
United Kingdom	Chelsea & Westminster Hospital NHS Foundation Trust	London
United Kingdom	King's College London	London

Sponsors (4)

Lead Sponsor	Collaborator
King's College London	Chelsea and Westminster NHS Foundation Trust, Imperial College London, University College, London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Published peer-reviewed paper