OPEN Feasibility Study

King's College London

Status: Unknown

Conditions: HIV Neuropathy

Treatments: Other: Waiting list control; Behavioral: ACT OPEN

Study type: Interventional

Funder types: Other

Identifiers

NCT03584412

236730

PDF-2015-08-059 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

ACT OPEN

Experimental group

Description:

Acceptance and Commitment Therapy Online for Painful Peripheral Neuropathy (ACT OPEN).

Treatment:

Behavioral: ACT OPEN

Waiting List Control

Other group

Description:

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.

Treatment:

Other: Waiting list control