OPEN Feasibility Study

NCT03584412 | Unknown

• 2 other identifiers: 236730PDF-2015-08-059
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

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.

Conditions

HIV Neuropathy

Outcome Measures

Primary Outcomes (7)

• Recruitment Rate

  Proportion of participants randomised relative to total trial referrals

  Baseline

• Retention Rate

  Proportion of participants who complete follow-up questionnaires

  8 weeks post-randomisation

• Treatment Completion Rate

  We expect 70% of participants to complete at least 8/12 ACT OPEN sessions

  8 weeks following receipt of treatment

• Treatment Satisfaction

  Total score on the Client Satisfaction Questionnaire (range: 8-32; higher scores reflect greater satisfaction)

  8 weeks following receipt of treatment

• Data Completeness

  Proportion of missing items on individual questionnaires

  Baseline

• Other Treatments Accessed

  Self-reported frequency of use of other treatments (e.g., medical, complimentary, etc)

  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))

  8 weeks following receipt of treatment

Secondary Outcomes (5)

• Pain Interference

  8 weeks post-randomisation

• Social and Occupational Functioning

  8 weeks post-randomisation

• Depression Symptoms

  8 weeks post-randomisation

• Pain Acceptance

  8 weeks post-randomisation

• Pain Intensity

  8 weeks post-randomisation

Study Arms (2)

ACT OPEN

EXPERIMENTAL

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

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.

Other: Waiting list control

Interventions

ACT OPEN BEHAVIORAL

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.

ACT OPEN

Waiting list control OTHER

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.

Waiting List Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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
• Unable to provide informed consent

Sponsors & Collaborators

• King's College London: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• King's College Hospital NHS Trust: collaborator
• Chelsea and Westminster NHS Foundation Trust: collaborator

Study Sites (3)

Chelsea and Westminster Hospital

London, SE1 9RT, United Kingdom

Location

Guy's and St Thomas' Hospital NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

King's College Hospital

London, SE1 9RT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33711209 DERIVED

Study Officials

• Whitney Scott, PhD

  Whitney Scott

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: July 12, 2018
• Study Start: July 9, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

GB (3)