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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02972606
Enrollment
26
Registered
2016-11-23
Start date
2016-11-30
Completion date
2017-07-31
Last updated
2023-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Peripheral Neuropathy

Keywords

HIV, Peripheral Neuropathy, Chronic Pain, Qualitative Research

Brief 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.

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.

Interventions

None listed

Sponsors

Imperial College London
CollaboratorOTHER
Chelsea and Westminster NHS Foundation Trust
CollaboratorOTHER
University College, London
CollaboratorOTHER
King's College London
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Who Completed a Semi-Structure InterviewDay 1Semi-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.

Countries

United Kingdom

Participant flow

Participants by arm

ArmCount
Participants With HIV and Neuropathy
Participants with HIV and Neuropathy who completed semi-structured interviews.
26
Total26

Baseline characteristics

CharacteristicParticipants With HIV and Neuropathy
Age, Continuous53.7 years
STANDARD_DEVIATION 9.7
Race/Ethnicity, Customized
Race/Ethnicity
Black British/African
9 Participants
Race/Ethnicity, Customized
Race/Ethnicity
White British/European
17 Participants
Region of Enrollment
United Kingdom
26 participants
Sex: Female, Male
Female
12 Participants
Sex: Female, Male
Male
14 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

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.

Time frame: Day 1

Population: All participants were analysed

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Not ApplicableNumber of Participants Who Completed a Semi-Structure Interview26 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026