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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03584412
Other study ID # 236730
Secondary ID PDF-2015-08-059
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 9, 2018
Est. completion date December 31, 2019

Study information

Verified date August 2019
Source King's College London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

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

Sponsors (4)

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT01537705 - A Clinical Outcomes Study to Measure Reduction in Pain and Numbness During Administration of an Amino Acid Formulation in Subjects Diagnosed With Peripheral Neuropathy Phase 2
Completed NCT03099005 - Effect of Cannabis and Endocannabinoids on HIV Neuropathic Pain Phase 2
Completed NCT00904202 - A Study Of Lidocaine Patch 5% Alone, Gabapentin Alone, And Lidocaine Patch 5% And Gabapentin In Combination For The Relief Of Pain In Patients With Diverse Peripheral Neuropathic Pain Conditions Phase 4
Recruiting NCT03855111 - Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain N/A