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HIVHIVPassNCT02766751

Treating Comorbid Pain and Depression in HIV+ Individuals

A study testing HIVPASS and Health Education in people with HIV and Depression, run by Butler Hospital at 4 sites 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

This study is designed to look at two different programs that may help people who are HIV+ and have pain and depression. The investigators are trying to understand how to help people learn to live better lives even with these chronic illnesses. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV, Depression, Pain
What is being tested?
HIVPASS and Health Education
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
187 participants
Where
4 sitesUnited States
Study dates
15 Nov 2016to May 2021
Phase
Interventional
Are there results?
None posted in the registry

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

  • Chronic Pain (pain duration for at least six months with a mean score of greater than 3.5 on the BPI Pain Interference Scale)
  • Pain severity > or equal to 4 on a Numeric Rating Scale indicating "average pain in the last week"
  • At least one trial of PCP-recommended medication (i.e. acetaminophen, NSAIDS, muscle relaxants) judged through interviews with patients and PCPs
  • Quick Inventory of Depression Symptoms (QIDS) score of ≥ 9 (depression severity)
  • Stable dose of an antidepressant, if using, for the previous 1 months
  • Age > or equal to 18
Show all 9Show fewer
  • HIV+
  • Planning to live in the area for the next 6 months
  • Access to a telephone that is typically working.

Who cannot join

  • In psychotherapy or a multidisciplinary pain management program
  • Planned surgery in the next 6 months
  • Pain thought due to cancer
  • Current mania
  • Past year chronic psychotic condition
  • Excessive substance use (Use of cocaine, heroin, or non-prescribe opioids 15 days per month or more; binge alcohol use 4 days per month or more)
  • Suicidality requiring immediate attention
  • Pregnancy or planned pregnancy in the next 6 months

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Boston University/Boston Medical Center

    Boston, Massachusetts, 02118

  • Hennepin Healthcare

    Minneapolis, Minnesota, 55415

  • Butler Hospital

    Providence, Rhode Island, 02906

  • The Miriam Hospital

    Providence, Rhode Island, 02906

Other trials in United States

About this study

This study is designed to look at two different programs that may help people who are HIV+ and have pain and depression. The investigators are trying to understand how to help people learn to live better lives even with these chronic illnesses.

Read the detailed description

The primary aim of this RCT is to evaluate the HIVPass intervention. HIV+ participants (n=236) with chronic pain and depression will be recruited at primary care HIV Clinics through posted advertisements in the waiting rooms of the PCP offices and by physician referral. After an initial phone study screen, research staff will meet with interested individuals in their PCP offices for informed consent, baseline interview and randomization into one of two study groups (Health Education or HIVPass Counseling). Seven intervention sessions (HE or HIVPASS) will occur during the first 3 months of study participation. For all participants, the first session is a collaborative in-person joint session with the participant, his/her PCP and the study BHS. Session 2 is conducted immediately after this collaborative session, and is also in-person. Sessions 3-7 are conducted by phone. Follow-up assessment interviews will be at months 1, 2, 3 (post-intervention), 4, 6, 9 and 12.

Conditions
HIV, Depression, Pain
Being tested
HIVPASS, Health Education
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

    The 7-session HIVPASS intervention is provided to individuals randomized to the HIVPASS study arm.

  • Health EducationBehavioural

    The 7-sessions of Health Education is provided to individuals randomized to the Health Education study arm.

Study groups in NCT02766751
Study groupRoleWhat they receive
Health EducationPlacebo comparatorThe seven sessions will cover: 1) nutrition (2 sessions), 2) sleep hygiene, 3) building immunity (e.g., how to avoid colds/flu), 4) injury/disease prevention (e.g., seat belts, sunscreen, when to get regular check-ups/screenings etc.), 5) benefits of exercise/cardiac health, 6) alternative medicine (massage, acupuncture). These sessions will be primarily didactic and consist of health education, followed by discussion as to how this information compares to that which the participants may have been exposed to in the past.
Receives: Behavioral: Health Education
HIVPASSExperimentalOver 7 sessions, the interventionist and the participant will explore the relationship between pain, depressive symptoms, and HIV. General information about pain, HIV and depression will be discussed, as will avoidance of physical activity. Psychoeducation about these areas will be tied to the participant's stated life goals, and exposure exercises and goal lists will be developed. Later sessions will integrate continued efforts towards reaching goals and reducing avoidance. A release of information will be obtained from the participant to allow study session chart notes to be placed in the medical record at the participant's PCP office and to allow the PCP and the study interventionist to discuss treatment coordination.
Receives: Behavioral: HIVPASS

What is being measured

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

  1. pain interference

    Brief pain inventory, interference scale

    Measured: 3 months

Secondary outcomes (8)

  1. depression

    Quick Inventory of depression symptoms

    Measured: 3 months; 12 months

  2. activity level

    Assessed with actigraphy

    Measured: 3 months; 12 months

  3. anxiety

    State-Trait Anxiety Inventory

    Measured: 3 months; 12 months

  4. viral load

    Measured: 3 months, 12 months

  5. ART adherence

    AIDS Clinical Trial Group questionnaire

    Measured: 3 months, 12 months

  6. perception of global improvement

    Patient Global Impression of Change Scale

    Measured: 3 months, 12 months

  7. health related quality of life

    Short Form 36 Health Survey

    Measured: 3 months, 12 onths

  8. pain interference

    brief pain inventory, interference scale

    Measured: 12 months

Timeline

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

  1. First posted10 May 2016 (estimated)
  2. Study start15 Nov 2016
  3. Primary completionJul 2020
  4. Study completionMay 2021

Resources

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
NCT02766751
Sponsor's protocol ID
840019
Acronym
HIVPass
Status last verified
Jun 2021
First submitted
6 May 2016
Last updated
10 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Uebelacker LA, Pinkston MM, Busch AM, Baker JV, Anderson B, Caviness CM, Herman DS, Weisberg RB, Abrantes AM, Stein MD. HIV-PASS (Pain and Sadness Support): Randomized Controlled Trial of a Behavioral Health Intervention for Interference Due to Pain in People Living With HIV, Chronic Pain, and Depression. Psychosom Med. 2023 Apr 1;85(3):250-259. doi: 10.1097/PSY.0000000000001172. Epub 2023 Feb 3.

    PubMed 36799731

  • Pinkston MM, Busch AM, Stein M, Baker J, Caviness C, Herman D, Weisberg R, Abrantes AM, Uebelacker LA. Improving functioning in HIV+ patients with chronic pain and comorbid depression: Protocol for a randomized clinical trial testing a collaborative behavioral health intervention based on behavioral activation. Contemp Clin Trials. 2022 Aug;119:106842. doi: 10.1016/j.cct.2022.106842. Epub 2022 Jun 28.

    PubMed 35777696

Questions about this trial

What is this clinical trial studying?

A study testing HIVPASS and Health Education in people with HIV and Depression, run by Butler Hospital at 4 sites 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 9 inclusion and 8 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 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

pain interference (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 NCT02766751, which also lists 2 linked publications.

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 Jun 2021.

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