HIV NeuropathyNCT03584412
OPEN Feasibility Study
A study testing ACT OPEN in people with HIV Neuropathy, run by King's College London at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Neuropathy
- What is being tested?
- ACT OPEN
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 9 Jul 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Chelsea and Westminster Hospital
London, SE1 9RT
Guy's and St Thomas' Hospital NHS Foundation Trust
London, SE1 9RT
King's College Hospital
London, SE1 9RT
About this 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
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.
Read the 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.
- Conditions
- HIV Neuropathy
- Being tested
- ACT OPEN, Waiting list control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT OPENBehavioural
Participants will access the ACT OPEN treatment through a secure online platform. Each session consists of brief videos and audio recordings that provide information about pain and guide participants through experiential exercises (e.g., mindfulness, values clarification, goal-setting). Participants will respond to questions assessing their experiences during the session and their progress using online messaging and/or brief telephone calls according to their preference. Therapists will provide individualised feedback. ACT OPEN consists of 12 sessions over 6 weeks. Participants will be given two further weeks to finish any uncompleted sessions, or to complete additional sessions (up to four) as agreed with their therapist.
Waiting list controlOther
Participants will receive their usual treatment for 5 months, after which they will complete ACT OPEN as described. A waiting list control was chosen as there is no clearly credible active psychotherapy to serve as the comparator in this context, particularly in light of high drop-out rates in two previous studies of CBT for pain in HIV. Providing the online treatment without therapist support may appear to be a logical comparison group instead of a waitlist control. However, there is evidence that therapist support is a key component of online CBT and, therefore, without this support it may not represent a credible treatment against which to judge the full treatment. In the context of the feasibility aims of this trial these reasons, the use of a waiting list control is thus justified.
| Study group | Role | What they receive |
|---|---|---|
| ACT OPEN | Experimental | Acceptance and Commitment Therapy Online for Painful Peripheral Neuropathy (ACT OPEN). Receives: Behavioral: ACT OPEN |
| Waiting List Control | Other | Participants in this condition will not receive any change to their usual treatment for a period of 5 months, after which they will be given access to complete the ACT OPEN treatment. Receives: Other: Waiting list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Proportion of participants randomised relative to total trial referrals
Measured: Baseline
Retention Rate
Proportion of participants who complete follow-up questionnaires
Measured: 8 weeks post-randomisation
Treatment Completion Rate
We expect 70% of participants to complete at least 8/12 ACT OPEN sessions
Measured: 8 weeks following receipt of treatment
Treatment Satisfaction
Total score on the Client Satisfaction Questionnaire (range: 8-32; higher scores reflect greater satisfaction)
Measured: 8 weeks following receipt of treatment
Data Completeness
Proportion of missing items on individual questionnaires
Measured: Baseline
Other Treatments Accessed
Self-reported frequency of use of other treatments (e.g., medical, complimentary, etc)
Measured: 8 weeks post-randomisation
Patient's impression of overall change during treatment
Score on single item Patient Global Impression of Change Rating (range: 1 (very much improved) to 7 (very much worse))
Measured: 8 weeks following receipt of treatment
Secondary outcomes (5)
Pain Interference
Brief Pain Inventory average of pain interference subscale items score (range 0-10; higher scores reflect greater pain interference)
Measured: 8 weeks post-randomisation
Social and Occupational Functioning
Work and Social Adjustment Scale Total Score (range: 0-40; higher scores reflect greater impairment in social and occupational functioning)
Measured: 8 weeks post-randomisation
Depression Symptoms
PHQ-9 Total Score (range: 0-27; higher scores reflect more severe depression symptoms)
Measured: 8 weeks post-randomisation
Pain Acceptance
Chronic Pain Acceptance Questionnaire--8 Item Version Total Score (range: 0-48; higher scores reflect greater acceptance)
Measured: 8 weeks post-randomisation
Pain Intensity
Average of the Brief Pain Inventory pain intensity items (range: 0-10; higher scores reflect more intense pain)
Measured: 8 weeks post-randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start9 Jul 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, King's College Hospital NHS Trust, Chelsea and Westminster NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Whitney Scott, PhD, Principal investigator, Whitney Scott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584412
- Sponsor's protocol ID
- 236730
- Other IDs
- PDF-2015-08-059
- Status last verified
- Aug 2019
- First submitted
- 18 Jun 2018
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33711209
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03584412
- Acronym / sponsor ID
- 236730
- Conditions
- HIV Neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, King's College Hospital NHS Trust, Chelsea and Westminster NHS Foundation Trust
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 12 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| ACT OPEN | Experimental | Behavioral: ACT OPENAcceptance and Commitment Therapy Online for Painful Peripheral Neuropathy (ACT OPEN). |
| Waiting List Control | Other | Other: Waiting list controlParticipants in this condition will not receive any change to their usual treatment for a period of 5 months, after which they will be given access to complete the ACT OPEN treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT OPENParticipants will access the ACT OPEN treatment through a secure online platform. Each session consists of brief videos and audio recordings that provide information about pain and guide participants through experiential exercises (e.g., mindfulness, values clarification, goal-setting). Participants will respond to questions assessing their experiences during the session and their progress using online messaging and/or brief telephone calls according to their preference. Therapists will provide individualised feedback. ACT OPEN consists of 12 sessions over 6 weeks. Participants will be given two further weeks to finish any uncompleted sessions, or to complete additional sessions (up to four) as agreed with their therapist. | Behavioural | ACT OPEN |
| Waiting list controlParticipants will receive their usual treatment for 5 months, after which they will complete ACT OPEN as described. A waiting list control was chosen as there is no clearly credible active psychotherapy to serve as the comparator in this context, particularly in light of high drop-out rates in two previous studies of CBT for pain in HIV. Providing the online treatment without therapist support may appear to be a logical comparison group instead of a waitlist control. However, there is evidence that therapist support is a key component of online CBT and, therefore, without this support it may not represent a credible treatment against which to judge the full treatment. In the context of the feasibility aims of this trial these reasons, the use of a waiting list control is thus justified. | Other | Waiting List Control |
Primary outcome
Recruitment Rate
Time frame: Baseline
Proportion of participants randomised relative to total trial referrals
Retention Rate
Time frame: 8 weeks post-randomisation
Proportion of participants who complete follow-up questionnaires
Treatment Completion Rate
Time frame: 8 weeks following receipt of treatment
We expect 70% of participants to complete at least 8/12 ACT OPEN sessions
Treatment Satisfaction
Time frame: 8 weeks following receipt of treatment
Total score on the Client Satisfaction Questionnaire (range: 8-32; higher scores reflect greater satisfaction)
Data Completeness
Time frame: Baseline
Proportion of missing items on individual questionnaires
Other Treatments Accessed
Time frame: 8 weeks post-randomisation
Self-reported frequency of use of other treatments (e.g., medical, complimentary, etc)
Patient's impression of overall change during treatment
Time frame: 8 weeks following receipt of treatment
Score on single item Patient Global Impression of Change Rating (range: 1 (very much improved) to 7 (very much worse))
5 secondary outcomes
Pain Interference
Time frame: 8 weeks post-randomisation
Social and Occupational Functioning
Time frame: 8 weeks post-randomisation
Depression Symptoms
Time frame: 8 weeks post-randomisation
Pain Acceptance
Time frame: 8 weeks post-randomisation
Pain Intensity
Time frame: 8 weeks post-randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Derived from this study: PubMed 33711209Scott 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.
- Individual participant dataSharing planned: Undecided
Related trials for HIV Neuropathy
Recruiting
Auricular Vagus Nerve Stimulation Mechanisms for HIV-Associated Peripheral Neuropathy
HIV Associated Polyneuropathy
Active, not recruitingObservational study
Study of Neurological Aging Among People Living With HIV
Aging, Premature
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Whitney Scott, PhD principal investigator
Whitney Scott
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT OPEN in people with HIV Neuropathy, run by King's College London at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03584412, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.