HIV Neuropathy Clinical Trial
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
Verified date | August 2019 |
Source | King's College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 70 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Chelsea and Westminster Hospital | London | |
United Kingdom | Guy's and St Thomas' Hospital NHS Foundation Trust | London | |
United Kingdom | King's College Hospital | London |
Lead Sponsor | Collaborator |
---|---|
King's College London | Chelsea and Westminster NHS Foundation Trust, Guy's and St Thomas' NHS Foundation Trust, King's College Hospital NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment Rate | Proportion of participants randomised relative to total trial referrals | Baseline | |
Primary | Retention Rate | Proportion of participants who complete follow-up questionnaires | 8 weeks post-randomisation | |
Primary | Treatment Completion Rate | We expect 70% of participants to complete at least 8/12 ACT OPEN sessions | 8 weeks following receipt of treatment | |
Primary | Treatment Satisfaction | Total score on the Client Satisfaction Questionnaire (range: 8-32; higher scores reflect greater satisfaction) | 8 weeks following receipt of treatment | |
Primary | Data Completeness | Proportion of missing items on individual questionnaires | Baseline | |
Primary | Other Treatments Accessed | Self-reported frequency of use of other treatments (e.g., medical, complimentary, etc) | 8 weeks post-randomisation | |
Primary | 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)) | 8 weeks following receipt of treatment | |
Secondary | Pain Interference | Brief Pain Inventory average of pain interference subscale items score (range 0-10; higher scores reflect greater pain interference) | 8 weeks post-randomisation | |
Secondary | Social and Occupational Functioning | Work and Social Adjustment Scale Total Score (range: 0-40; higher scores reflect greater impairment in social and occupational functioning) | 8 weeks post-randomisation | |
Secondary | Depression Symptoms | PHQ-9 Total Score (range: 0-27; higher scores reflect more severe depression symptoms) | 8 weeks post-randomisation | |
Secondary | Pain Acceptance | Chronic Pain Acceptance Questionnaire--8 Item Version Total Score (range: 0-48; higher scores reflect greater acceptance) | 8 weeks post-randomisation | |
Secondary | Pain Intensity | Average of the Brief Pain Inventory pain intensity items (range: 0-10; higher scores reflect more intense pain) | 8 weeks post-randomisation |
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