Chronic PainNCT02824562
Pilot Testing of a Behavioral Intervention for Chronic Pain in Individuals With HIV
A study testing Intervention in people with Chronic Pain, run by University of Pittsburgh at 1 site in United States.
Trial summary
Due to its specific pathophysiology and impact on health outcomes, the Institute of Medicine has described chronic pain as a complex chronic disease and a "national public health crisis." The unique neurobiological basis and psychosocial context of chronic pain in HIV-infected patients underscores the importance of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 22 Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled in the Center for AIDS Research Network of Integrated Clinical Systems (CNICS) cohort
- Age ≥ 18 years
- Chronic pain (Brief Chronic Pain Screening Questionnaire (BCPQ) = at least moderate pain for at least 3 months)
- Moderately severe and impairing chronic pain (PEG pain questionnaire = average of all three times is 4 or greater)
Who cannot join
- Do not speak or understand English
- Are planning a new pain treatment like surgery
- Cannot attend the group sessions.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: Development of a Behavioral Intervention for Chronic Pain in Individuals With HIV
Due to its specific pathophysiology and impact on health outcomes, the Institute of Medicine has described chronic pain as a complex chronic disease and a "national public health crisis." The unique neurobiological basis and psychosocial context of chronic pain in HIV-infected patients underscores the importance of developing and testing a behavioral intervention specifically tailored to this population. This study will pilot test a newly-developed behavioral intervention for chronic pain tailored to individuals with HIV.
Read the detailed description
Chronic pain is a chronic condition with a unique neurobiologic basis, which has a substantial impact on physical and emotional function. Chronic pain in HIV-infected patients is common, and associated with serious health consequences, including up to 10 times greater odds of impaired physical function. Many pharmacologic therapies, including opioids, often do not lead to improved pain and function, and carry significant risk. Evidence-based behavioral interventions are among the most effective and safe non-pharmacologic chronic pain treatments investigated in the general medical population. Therefore, behavioral interventions to improve pain, physical, and emotional function in HIV-infected patients are needed. There is much to be learned from existing interventions. However, the success of a behavioral intervention is heavily influenced by how well it is tailored to the target population's biological, psychological, and social environment. Therefore, in this study investigators will conduct a two-arm pilot randomized controlled trial of a recently-developed behavioral intervention compared to routine HIV and pain care, to determine feasibility, acceptability, and preliminary impact.
- Conditions
- Chronic Pain
- Being tested
- Intervention, Control
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
The intervention group will receive treatment as usual plus a chronic pain self-management program which includes six one-on-one sessions facilitated by a trained interventionist and six group sessions facilitated by a trained interventionist and a peer. A peer is an HIV-infected patient living with chronic pain, who has completed all ten of the one-on-one sessions offered, received training to co-facilitate the six group sessions with the interventionist, and is successfully self-managing his/her chronic pain.
ControlBehavioural
The control group will receive "treatment as usual". The "treatment as usual" or control group refers to the standard of care that patients receive for their chronic pain. This standard of care allows patients to discuss chronic pain with their providers at their discretion. Although highly variable, providers can recommend and prescribe pharmacologic (e.g., opioid and other pain medication), non-pharmacologic (e.g., physical therapy, referral to psychology) approaches for pain. This study will not interfere in any way with usual care. No additional treatment will be provided to participants allocated to the control group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | The intervention group will receive treatment as usual plus a chronic pain self-management program which includes six one-on-one sessions facilitated by a trained interventionist and six group sessions facilitated by a trained interventionist and a peer. A peer is an HIV-infected patient living with chronic pain, who has completed all ten of the one-on-one sessions offered, received training to co-facilitate the six group sessions with the interventionist, and is successfully self-managing his/her chronic pain. The participants will complete an outcome assessment within 30 days of the last group session. Receives: Behavioral: Intervention |
| Control | Other | The control group will receive "treatment as usual". The "treatment as usual" or control group refers to the standard of care that patients receive for their chronic pain. This standard of care allows patients to discuss chronic pain with their providers at their discretion. Although highly variable, providers can recommend and prescribe pharmacologic (e.g., opioid and other pain medication), non-pharmacologic (e.g., physical therapy, referral to psychology) approaches for pain. This study will not interfere in any way with usual care. No additional treatment will be provided to participants allocated to the control group. The participants will complete an outcome assessment within 30 days of the last group session. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Feasibility: Median Number of Study Intervention Sessions Attended by Participants
Participants are expected to attend 6 one-on-one sessions and 6 group sessions. Maximum sessions if all attended per participant would be 12 sessions.
Measured: From baseline throughout the entire 16 week intervention period
Secondary outcomes (1)
Outcome Assessment Feasibility: Number (Percentage) of Participants Who Complete Outcome Assessments Within One Month
Outcome assessments are administered to participants by study staff.
Measured: From the conclusion of the intervention through 30 days (Intervention Group). From the last group session through 30 days (Control Group).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion1 Jun 2017
- Study completion22 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Merlin, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824562
- Sponsor's protocol ID
- X160328007
- Status last verified
- Dec 2017
- First submitted
- 28 Jun 2016
- Last updated
- 10 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Merlin JS, Westfall AO, Johnson MO, Kerns RD, Bair MJ, Kertesz S, Turan JM, Clay OJ, Starrels JL, Kilgore M. Cost-effectiveness of a chronic pain intervention for people living with HIV (PLWH). J Med Econ. 2018 Feb;21(2):122-126. doi: 10.1080/13696998.2017.1377719. Epub 2017 Sep 18.
PubMed 28880698
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Behavioral Intervention for Chronic Pain in Individuals With HIV
- ClinicalTrials.gov ID
- NCT02824562
- Acronym / sponsor ID
- X160328007
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 22 Aug 2017 (actual)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Posted 10 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Due to its specific pathophysiology and impact on health outcomes, the Institute of Medicine has described chronic pain as a complex chronic disease and a "national public health crisis." The unique neurobiological basis and psychosocial context of chronic pain in HIV-infected patients underscores the importance of developing and testing a behavioral intervention specifically tailored to this population. This study will pilot test a newly-developed behavioral intervention for chronic pain tailored to individuals with HIV.
Detailed description
Chronic pain is a chronic condition with a unique neurobiologic basis, which has a substantial impact on physical and emotional function. Chronic pain in HIV-infected patients is common, and associated with serious health consequences, including up to 10 times greater odds of impaired physical function. Many pharmacologic therapies, including opioids, often do not lead to improved pain and function, and carry significant risk. Evidence-based behavioral interventions are among the most effective and safe non-pharmacologic chronic pain treatments investigated in the general medical population. Therefore, behavioral interventions to improve pain, physical, and emotional function in HIV-infected patients are needed. There is much to be learned from existing interventions. However, the success of a behavioral intervention is heavily influenced by how well it is tailored to the target population's biological, psychological, and social environment. Therefore, in this study investigators will conduct a two-arm pilot randomized controlled trial of a recently-developed behavioral intervention compared to routine HIV and pain care, to determine feasibility, acceptability, and preliminary impact.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Behavioral: InterventionThe intervention group will receive treatment as usual plus a chronic pain self-management program which includes six one-on-one sessions facilitated by a trained interventionist and six group sessions facilitated by a trained interventionist and a peer. A peer is an HIV-infected patient living with chronic pain, who has completed all ten of the one-on-one sessions offered, received training to co-facilitate the six group sessions with the interventionist, and is successfully self-managing his/her chronic pain. The participants will complete an outcome assessment within 30 days of the last group session. |
| Control | Other | Behavioral: ControlThe control group will receive "treatment as usual". The "treatment as usual" or control group refers to the standard of care that patients receive for their chronic pain. This standard of care allows patients to discuss chronic pain with their providers at their discretion. Although highly variable, providers can recommend and prescribe pharmacologic (e.g., opioid and other pain medication), non-pharmacologic (e.g., physical therapy, referral to psychology) approaches for pain. This study will not interfere in any way with usual care. No additional treatment will be provided to participants allocated to the control group. The participants will complete an outcome assessment within 30 days of the last group session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Enrolled in the Center for AIDS Research Network of Integrated Clinical Systems (CNICS) cohort
- Age ≥ 18 years
- Chronic pain (Brief Chronic Pain Screening Questionnaire (BCPQ) = at least moderate pain for at least 3 months)
- Moderately severe and impairing chronic pain (PEG pain questionnaire = average of all three times is 4 or greater)
Key exclusion criteria (3 listed)
- Do not speak or understand English
- Are planning a new pain treatment like surgery
- Cannot attend the group sessions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionThe intervention group will receive treatment as usual plus a chronic pain self-management program which includes six one-on-one sessions facilitated by a trained interventionist and six group sessions facilitated by a trained interventionist and a peer. A peer is an HIV-infected patient living with chronic pain, who has completed all ten of the one-on-one sessions offered, received training to co-facilitate the six group sessions with the interventionist, and is successfully self-managing his/her chronic pain. | Behavioural | Intervention |
| ControlThe control group will receive "treatment as usual". The "treatment as usual" or control group refers to the standard of care that patients receive for their chronic pain. This standard of care allows patients to discuss chronic pain with their providers at their discretion. Although highly variable, providers can recommend and prescribe pharmacologic (e.g., opioid and other pain medication), non-pharmacologic (e.g., physical therapy, referral to psychology) approaches for pain. This study will not interfere in any way with usual care. No additional treatment will be provided to participants allocated to the control group. | Behavioural | Control |
Primary outcome
Intervention Feasibility: Median Number of Study Intervention Sessions Attended by Participants
Time frame: From baseline throughout the entire 16 week intervention period
Participants are expected to attend 6 one-on-one sessions and 6 group sessions. Maximum sessions if all attended per participant would be 12 sessions.
1 secondary outcome
Outcome Assessment Feasibility: Number (Percentage) of Participants Who Complete Outcome Assessments Within One Month
Time frame: From the conclusion of the intervention through 30 days (Intervention Group). From the last group session through 30 days (Control Group).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28880698Merlin JS, Westfall AO, Johnson MO, Kerns RD, Bair MJ, Kertesz S, Turan JM, Clay OJ, Starrels JL, Kilgore M. Cost-effectiveness of a chronic pain intervention for people living with HIV (PLWH). J Med Econ. 2018 Feb;21(2):122-126. doi: 10.1080/13696998.2017.1377719. Epub 2017 Sep 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Chronic Pain, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Feasibility: Median Number of Study Intervention Sessions Attended by Participants (time frame: From baseline throughout the entire 16 week intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02824562, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2018.