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OpenTrials
Completed

NCT Number: NCT02766751

Treating Comorbid Pain and Depression in HIV+ Individuals

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston University/Boston Medical Center, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • HIV+
  • Planning to live in the area for the next 6 months
  • Access to a telephone that is typically working.

Exclusion criteria

  • 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

Treatment and study plan

HIVPASS

Behavioral

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

Health Education

Behavioral

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

Primary outcomes

  1. pain interference

    Time frame: 3 months

    Brief pain inventory, interference scale

Secondary outcomes

  1. depression

    Time frame: 3 months; 12 months

    Quick Inventory of depression symptoms

  2. activity level

    Time frame: 3 months; 12 months

    Assessed with actigraphy

  3. anxiety

    Time frame: 3 months; 12 months

    State-Trait Anxiety Inventory

  4. viral load

    Time frame: 3 months, 12 months

  5. ART adherence

    Time frame: 3 months, 12 months

    AIDS Clinical Trial Group questionnaire

  6. perception of global improvement

    Time frame: 3 months, 12 months

    Patient Global Impression of Change Scale

  7. health related quality of life

    Time frame: 3 months, 12 onths

    Short Form 36 Health Survey

  8. pain interference

    Time frame: 12 months

    brief pain inventory, interference scale

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Registry information

Acronym: HIVPass

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
May 10, 2016
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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