Pain InterferenceHIVPASSNCT01735708

Treating Chronic Pain and Depression in HIV+ Patients in Primary Care Settings

A study testing HIVPASS and Health Education in people with Pain Interference and Depression, run by Butler Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether participation in the study intervention, which involves collaboration between the study interventionist and the participant's primary care physician, will reduce symptoms of pain and depression in HIV+ patients. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Pain Interference, Depression, Antiretroviral Adherence
What is being tested?: HIVPASS and Health Education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 187 participants
Where: 1 siteUnited States
Study dates: Nov 2012to Aug 2015
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Chronic Pain (pain duration for at least six months with a mean score of 5 or higher on the BPI Pain Interference Scale)
Pain severity of 40 or higher on a Visual Analog Scale (0-100) indicating "worst pain in the last week"
At least one trial of PCP-recommended medication (i.e. acetominophen, NSAIDS, skeletal muscle relaxants) judged through interviews with patients and PCPs
QIDS score of ≥ 9 (depression severity)
Stable dose of an antidepressant, if using, for the previous 2 months
Age 18 or older
HIV+

Who cannot join

Lifetime DSM-IV diagnosis of bipolar disorder, schizophrenia, or other chronic psychotic condition
Current DSM-IV diagnosis of substance dependence for alcohol, sedative/ hypnotic drugs, stimulants, or cocaine
Suicidal ideation or behavior requiring immediate attention
In psychotherapy or in a multidisciplinary pain management program
Expected surgery in the next 6 months
Pain thought to be due to cancer, infection, or inflammatory arthritis
Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

Butler Hospital
Providence, Rhode Island, 02906

Other trials in United States

About this study

Conditions: Pain Interference, Depression, Antiretroviral Adherence
Being tested: HIVPASS, Health Education
Keywords: pain, depression, HIV, adherence
Medical subject headings: Depression, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HIVPASSBehavioural
Health EducationOther

Study groups in NCT01735708
Study group	Role	What they receive
Health Education	Placebo comparator	Participants in the Health Education arm will receive 7 individual sessions, each of which will focus on a different health education topic. Receives: Other: Health Education
HIVPASS Intervention	Active comparator	Participants in the HIVPASS intervention arm will receive 7 individual sessions with the study interventionist, the first of which is a collaborative meeting with the PCP. Sessions will focus on pain interference and depression management. Receives: Behavioral: HIVPASS

What is being measured

The primary outcome is the main question the study is designed to answer.

Brief Pain Inventory Interference Scale at 3 Months
Title: Brief Pain Inventory Interference Scale. Abbreviation: BPI-I. Measures: self-report of interference due to pain. Scale range: 0-10. Higher scores represent a worse outcome.
Measured: 3 months

Secondary outcomes (3)

Brief Pain Inventory Interference Scale at 12 Months
Title: Brief Pain Inventory Interference Scale. Abbreviation: BPI-I. Measures: self-report of interference due to pain. Scale range: 0-10. Higher scores represent a worse outcome.
Measured: 12 months
Quick Inventory of Depression Symptoms at 3 Months
Quick Inventory of Depressive Symptoms. Abbreviation: QIDS. Measures: clinician-based assessment of depression symptom severity. Scale range: 0-27. Higher scores represent a worse outcome.
Measured: 3 months
Quick Inventory of Depression Symptoms at 12 Months
Quick Inventory of Depressive Symptoms. Abbreviation: QIDS. Measures: clinician-based assessment of depression symptom severity. Scale range: 0-27. Higher scores represent a worse outcome.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012Aug 2015

First posted28 Nov 2012 (estimated)
Study startNov 2012
Primary completionAug 2014
Study completionAug 2015

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 Pain InterferenceStudies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 187 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01735708
Sponsor's protocol ID: NR13438
Other IDs: R21NR013438
Acronym: HIVPASS
Status last verified: Sep 2022
First submitted: 26 Nov 2012
Last updated: 13 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Uebelacker LA, Weisberg RB, Herman DS, Bailey GL, Pinkston-Camp MM, Garnaat SL, Stein MD. Pilot Randomized Trial of Collaborative Behavioral Treatment for Chronic Pain and Depression in Persons Living with HIV/AIDS. AIDS Behav. 2016 Aug;20(8):1675-81. doi: 10.1007/s10461-016-1397-7.
PubMed 27115400

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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SERENITY Study of Chronic Pain Interference in Adults
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Reducing Chronic Pain Following Cesarean Delivery
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All Pain Interference trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treating Chronic Pain and Depression in HIV+ Patients in Primary Care Settings
ClinicalTrials.gov ID: NCT01735708
Acronym / sponsor ID: HIVPASS / NR13438
Conditions: Pain Interference, Depression, Antiretroviral Adherence
Keywords: pain, depression, HIV, adherence
Study type: Interventional
Recruitment status: Completed
Enrolment: 187 participants (actual)
Lead sponsor: Butler HospitalUniversity, hospital or other
Collaborators: Brown University, National Institute of Nursing Research (NINR)
Study start: Nov 2012
Primary completion: Aug 2014 (actual)
Study completion: Aug 2015 (actual)
First posted: 28 Nov 2012 (estimated)
Results: Posted 13 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Health Education	Placebo comparator	Other: Health EducationParticipants in the Health Education arm will receive 7 individual sessions, each of which will focus on a different health education topic.
HIVPASS Intervention	Active comparator	Behavioral: HIVPASSParticipants in the HIVPASS intervention arm will receive 7 individual sessions with the study interventionist, the first of which is a collaborative meeting with the PCP. Sessions will focus on pain interference and depression management.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Chronic Pain (pain duration for at least six months with a mean score of 5 or higher on the BPI Pain Interference Scale)
Pain severity of 40 or higher on a Visual Analog Scale (0-100) indicating "worst pain in the last week"
At least one trial of PCP-recommended medication (i.e. acetominophen, NSAIDS, skeletal muscle relaxants) judged through interviews with patients and PCPs
QIDS score of ≥ 9 (depression severity)
Stable dose of an antidepressant, if using, for the previous 2 months

Key exclusion criteria (7 listed)

Lifetime DSM-IV diagnosis of bipolar disorder, schizophrenia, or other chronic psychotic condition
Current DSM-IV diagnosis of substance dependence for alcohol, sedative/ hypnotic drugs, stimulants, or cocaine
Suicidal ideation or behavior requiring immediate attention
In psychotherapy or in a multidisciplinary pain management program
Expected surgery in the next 6 months

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
HIVPASS	Behavioural	HIVPASS Intervention
Health Education	Other	Health Education

Primary outcome

Brief Pain Inventory Interference Scale at 3 Months
Time frame: 3 months
Title: Brief Pain Inventory Interference Scale. Abbreviation: BPI-I. Measures: self-report of interference due to pain. Scale range: 0-10. Higher scores represent a worse outcome.

3 secondary outcomes

Brief Pain Inventory Interference Scale at 12 Months
Time frame: 12 months
Quick Inventory of Depression Symptoms at 3 Months
Time frame: 3 months
Quick Inventory of Depression Symptoms at 12 Months
Time frame: 12 months

Results and safety

Results posted to the registry on 13 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Health Education	95	84
HIVPASS Intervention	92	79

Primary outcome: Brief Pain Inventory Interference Scale at 3 Months

Time frame: 3 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Health Education n = 79	HIVPASS Intervention n = 79
Value	5.03 (2.98)	4.23 (2.84)

Health Education vs HIVPASS Intervention: Mean Difference (Net): -1.31 (95% CI -2.28 to -0.34), p = 0.008, Mixed Models Analysis

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Health Education	39 of 95 (41.1%)	40 of 95 (42.1%)	2 of 95
HIVPASS Intervention	21 of 92 (22.8%)	35 of 92 (38%)	2 of 92

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27115400Uebelacker LA, Weisberg RB, Herman DS, Bailey GL, Pinkston-Camp MM, Garnaat SL, Stein MD. Pilot Randomized Trial of Collaborative Behavioral Treatment for Chronic Pain and Depression in Persons Living with HIV/AIDS. AIDS Behav. 2016 Aug;20(8):1675-81. doi: 10.1007/s10461-016-1397-7.

Related trials for Pain Interference

Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain
Not yet recruitingObservational study
SERENITY Study of Chronic Pain Interference in Adults
Chronic Low Back Pain, Spinal Cord Injury
Recruiting
Reducing Chronic Pain Following Cesarean Delivery
Chronic Pain, Cesarean Section Complications
Not yet recruiting
Multicomponent Pain Self-Management in Adults With Haemophilic Arthropathy
Hemophilic Arthropathy, Chronic Pain

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.

Michael Stein, MD principal investigator

Butler Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing HIVPASS and Health Education in people with Pain Interference and Depression, run by Butler Hospital 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 7 inclusion and 7 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 13 Oct 2022. 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. Some participants in this study may receive a placebo. 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 13 Oct 2022). 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?

Brief Pain Inventory Interference Scale at 3 Months (time frame: 3 months). 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 NCT01735708, 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 13 Oct 2022.