Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

OPEN Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03584412
Recruitment Status : Active, not recruiting
First Posted : July 12, 2018
Last Update Posted : August 13, 2019
Sponsor:
Collaborators:
Guy's and St Thomas' NHS Foundation Trust
King's College Hospital NHS Trust
Chelsea and Westminster NHS Foundation Trust
Information provided by (Responsible Party):
King's College London

Tracking Information
First Submitted Date  ICMJE June 18, 2018
First Posted Date  ICMJE July 12, 2018
Last Update Posted Date August 13, 2019
Actual Study Start Date  ICMJE July 9, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2018)
  • 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))
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03584412 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2018)
  • Pain Interference [ Time Frame: 8 weeks post-randomisation ]
    Brief Pain Inventory average of pain interference subscale items score (range 0-10; higher scores reflect greater pain interference)
  • Social and Occupational Functioning [ Time Frame: 8 weeks post-randomisation ]
    Work and Social Adjustment Scale Total Score (range: 0-40; higher scores reflect greater impairment in social and occupational functioning)
  • Depression Symptoms [ Time Frame: 8 weeks post-randomisation ]
    PHQ-9 Total Score (range: 0-27; higher scores reflect more severe depression symptoms)
  • Pain Acceptance [ Time Frame: 8 weeks post-randomisation ]
    Chronic Pain Acceptance Questionnaire--8 Item Version Total Score (range: 0-48; higher scores reflect greater acceptance)
  • Pain Intensity [ Time Frame: 8 weeks post-randomisation ]
    Average of the Brief Pain Inventory pain intensity items (range: 0-10; higher scores reflect more intense pain)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE OPEN Feasibility Study
Official Title  ICMJE Feasibility Randomized-Controlled Trial of Online Acceptance and Commitment Therapy for Painful Peripheral Neuropathy in People Living With HIV: The OPEN Feasibility Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE HIV Neuropathy
Intervention  ICMJE
  • Behavioral: ACT OPEN
    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.
  • Other: Waiting list control
    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 Arms  ICMJE
  • Experimental: ACT OPEN
    Acceptance and Commitment Therapy Online for Painful Peripheral Neuropathy (ACT OPEN).
    Intervention: Behavioral: ACT OPEN
  • Waiting List Control
    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.
    Intervention: Other: Waiting list control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 28, 2018)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03584412
Other Study ID Numbers  ICMJE 236730
PDF-2015-08-059 ( Other Grant/Funding Number: National Institute for Health Research )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party King's College London
Study Sponsor  ICMJE King's College London
Collaborators  ICMJE
  • Guy's and St Thomas' NHS Foundation Trust
  • King's College Hospital NHS Trust
  • Chelsea and Westminster NHS Foundation Trust
Investigators  ICMJE
Principal Investigator: Whitney Scott, PhD Whitney Scott
PRS Account King's College London
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP