Clinical trial NCT03584412: OPEN Feasibility Study
Official title: Feasibility Randomized-Controlled Trial of Online Acceptance and Commitment Therapy for Painful Peripheral Neuropathy in People Living With HIV: The OPEN Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Neuropathy
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Guy's and St Thomas' NHS Foundation Trust
name: King's College Hospital NHS Trust
name: Chelsea and Westminster NHS Foundation Trust
First posted: 2018-07-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to the ACT OPEN treatment condition immediately or following a 5 month wait using a 2:1 randomisation ratio (2: immediately; 1: waiting list control).
Primary purpose: TREATMENT

Brief summary: The current trial will explore the feasibility of a larger efficacy trial to test a newly developed form of online CBT called Acceptance and Commitment Therapy (which we have called "ACT OPEN") for people with HIV and painful peripheral neuropathy. Participants will be recruited from HIV clinics in London, UK. Participants will be randomly chosen to receive the new ACT OPEN treatment right away or after waiting for 5 months. The treatment lasts for 8 weeks. Participants will complete self-report questionnaires to assess pain, functioning, and mood at the beginning of the study and 8 weeks and five months later.

Detailed description: The human immunodeficiency virus (HIV) is a major health problem in the United Kingdom and worldwide. Neuropathic pain in the feet related to peripheral neuropathy is one of the most common symptoms associated with HIV. This pain is difficult to treat and medications are not effective. Chronic pain in people with HIV is related to higher levels of disability and poor quality of life.

Psychological treatments like cognitive behaviour therapy (CBT) can improve quality of life for people with chronic pain in general (not HIV-related), and there have been efforts to provide more accessible versions of CBT over the Internet. However, it is not known whether Internet-based CBT is helpful for people with HIV and chronic pain.

The current trial will explore the feasibility of a newly developed form of online CBT called Acceptance and Commitment Therapy (which we have called "ACT OPEN") for people with HIV and painful peripheral neuropathy. Participants will be recruited from HIV clinics in London, UK. Participants will be randomly chosen to receive the new ACT OPEN treatment right away or after waiting for 5 months. The treatment lasts for 8 weeks. Participants will complete self-report questionnaires to assess pain, functioning, and mood at the beginning of the study and 8 weeks and five months later.

The purpose of this study is to examine the feasibility of a larger trial evaluating the impact of online ACT for people with HIV and chronic pain in their feet. Key feasibility parameters that will be evaluated will include an estimate of the recruitment and retention rates, treatment completion rate and satisfaction, and an estimate of the effect size of changes in standard pain outcome measures.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years or older living with HIV.
* Positive screen for peripheral sensory neuropathy, as indicated by the presence of self-reported bilateral foot pain in a symmetrical distribution (Woldeamanuel et al., 2016).
* Positive screen for symptoms of neuropathic pain in the feet, as indicated by a score of 3 or more on the patient reported outcomes section of the DN4 Neuropathic Pain Interview (Bouhassira et al., 2005; Bouhassira, Lantéri-Minet, Attal, Laurent, \& Touboul, 2008)
* Pain in the feet present most days for at least 3 months.
* Average pain intensity over the past week of at least 4 on a scale from 0 (no pain) to 10 (pain as bad as you can imagine) (Zelman, Dukes, Brandenburg, Bostrom, \& Gore, 2005).
* Average interference of pain with daily activities over the past 3 months is at least 4 on a scale ranging from 0 (no interference) to 10 (unable to carry on any activities) (Von Korff, Ormel, Keefe, \& Dworkin, 1992).
* At least moderate symptoms of depression in the past 2 weeks, as indicated by a score of at least 10 on the PHQ-9 (Kroenke et al., 2001).

Exclusion Criteria:

* Severe symptoms of depression, as indicated by a PHQ-9 score of 23 or greater.
* Active suicidal ideation, as reflected by a score of 2 or greater on the PHQ-9 item 9 and current intent or plan to self-harm.
* A positive screen of self-reported alcohol or other substance abuse in the past 3 months as reflected by an ASSIST-Lite score of at least 3 for alcohol or at least 2 for other substances, including misuse of prescribed opioids.
* Presence of any other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, post-traumatic stress disorder) that is currently unstable or poorly controlled and likely to interfere with treatment engagement, as judged by a clinical psychologist conducting the screening.
* Currently receiving another form of regular psychotherapy (i.e., weekly appointments); involvement in psychotherapy or counselling appointments occurring less than weekly will be permitted.
* Changes to medications for mood and pain for the last 6 weeks.
* Major surgical procedure for any reason planned within the next 5 months.
* Unable to complete study procedures in English
* Unwilling to commit approximately 1-2 hours per week to complete the treatment and to do so over the Internet (note: access to a tablet/wifi will be provided for otherwise eligible participants who do not have such access; therefore, lack of internet access will not be an exclusion criterion)
* Unable to provide informed consent

Primary outcomes:
measure: Recruitment Rate
timeFrame: Baseline
measure: Retention Rate
timeFrame: 8 weeks post-randomisation
measure: Treatment Completion Rate
timeFrame: 8 weeks following receipt of treatment
measure: Treatment Satisfaction
timeFrame: 8 weeks following receipt of treatment
measure: Data Completeness
timeFrame: Baseline
measure: Other Treatments Accessed
timeFrame: 8 weeks post-randomisation
measure: Patient's impression of overall change during treatment
timeFrame: 8 weeks following receipt of treatment
Secondary outcomes:
measure: Pain Interference
timeFrame: 8 weeks post-randomisation
measure: Social and Occupational Functioning
timeFrame: 8 weeks post-randomisation
measure: Depression Symptoms
timeFrame: 8 weeks post-randomisation
measure: Pain Acceptance
timeFrame: 8 weeks post-randomisation
measure: Pain Intensity
timeFrame: 8 weeks post-randomisation
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
city: London
country: United Kingdom
facility: Guy's and St Thomas' Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: Whitney Scott
name: Whitney Scott, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scott W, Guildford BJ, Badenoch J, Driscoll E, Chilcot J, Norton S, Kemp HI, Lee MJ, Lwanga J, Boffito M, Moyle G, Post FA, Campbell L, Josh J, Clift P, C de C Williams A, Rice AS, McCracken LM. Feasibility randomized-controlled trial of online acceptance and commitment therapy for painful peripheral neuropathy in people living with HIV: The OPEN study. Eur J Pain. 2021 Aug;25(7):1493-1507. doi: 10.1002/ejp.1762. Epub 2021 Mar 26.