An interventional study of ACT OPEN and Waiting list control in HIV Neuropathy, sponsored by King's College London. Status unknown at 3 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-13.
Sponsored by King's College London · Not applicable, Interventional, and Treatment
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.
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.
King's College London is the lead sponsor of 506 studies on the registry; 125 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Acceptance and Commitment Therapy Online for Painful Peripheral Neuropathy (ACT OPEN).
Behavioral: ACT OPEN
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.
Other: Waiting list control
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.
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.
Recruitment Rate
Proportion of participants randomised relative to total trial referrals
Time frame: Baseline
Retention Rate
Proportion of participants who complete follow-up questionnaires
Time frame: 8 weeks post-randomisation
Treatment Completion Rate
We expect 70% of participants to complete at least 8/12 ACT OPEN sessions
Time frame: 8 weeks following receipt of treatment
Treatment Satisfaction
Total score on the Client Satisfaction Questionnaire (range: 8-32; higher scores reflect greater satisfaction)
Time frame: 8 weeks following receipt of treatment
Data Completeness
Proportion of missing items on individual questionnaires
Time frame: Baseline
Other Treatments Accessed
Self-reported frequency of use of other treatments (e.g., medical, complimentary, etc)
Time frame: 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))
Time frame: 8 weeks following receipt of treatment
Pain Interference
Brief Pain Inventory average of pain interference subscale items score (range 0-10; higher scores reflect greater pain interference)
Time frame: 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)
Time frame: 8 weeks post-randomisation
Depression Symptoms
PHQ-9 Total Score (range: 0-27; higher scores reflect more severe depression symptoms)
Time frame: 8 weeks post-randomisation
Pain Acceptance
Chronic Pain Acceptance Questionnaire--8 Item Version Total Score (range: 0-48; higher scores reflect greater acceptance)
Time frame: 8 weeks post-randomisation
Pain Intensity
Average of the Brief Pain Inventory pain intensity items (range: 0-10; higher scores reflect more intense pain)
Time frame: 8 weeks post-randomisation
Plan to share: Undecided
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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King's College London