Back to resultsTreating Comorbid Pain and Depression in HIV+ Individuals (HIVPass)
Primary Purpose
HIV, Depression, Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIVPASS
Health Education
Sponsored by
About this trial
This is an interventional treatment trial for HIV
Eligibility Criteria
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
Sites / Locations
- Boston University/Boston Medical Center
- Hennepin Healthcare
- Butler Hospital
- The Miriam Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Health Education
HIVPASS
Arm Description
The 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.
Over 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.
Outcomes
Primary Outcome Measures
pain interference
Brief pain inventory, interference scale
Secondary Outcome Measures
depression
Quick Inventory of depression symptoms
activity level
Assessed with actigraphy
anxiety
State-Trait Anxiety Inventory
viral load
ART adherence
AIDS Clinical Trial Group questionnaire
perception of global improvement
Patient Global Impression of Change Scale
health related quality of life
Short Form 36 Health Survey
pain interference
brief pain inventory, interference scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02766751
Brief Title
Treating Comorbid Pain and Depression in HIV+ Individuals
Acronym
HIVPass
Official Title
Treating Comorbid Pain and Depression in HIV+ Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 15, 2016 (Actual)
Primary Completion Date
July 2020 (Actual)
Study Completion Date
May 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Butler Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Depression, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
187 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Health Education
Arm Type
Placebo Comparator
Arm Description
The 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.
Arm Title
HIVPASS
Arm Type
Experimental
Arm Description
Over 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.
Intervention Type
Behavioral
Intervention Name(s)
HIVPASS
Intervention Description
The 7-session HIVPASS intervention is provided to individuals randomized to the HIVPASS study arm.
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
The 7-sessions of Health Education is provided to individuals randomized to the Health Education study arm.
Primary Outcome Measure Information:
Title
pain interference
Description
Brief pain inventory, interference scale
Time Frame
3 months
Secondary Outcome Measure Information:
Title
depression
Description
Quick Inventory of depression symptoms
Time Frame
3 months; 12 months
Title
activity level
Description
Assessed with actigraphy
Time Frame
3 months; 12 months
Title
anxiety
Description
State-Trait Anxiety Inventory
Time Frame
3 months; 12 months
Title
viral load
Time Frame
3 months, 12 months
Title
ART adherence
Description
AIDS Clinical Trial Group questionnaire
Time Frame
3 months, 12 months
Title
perception of global improvement
Description
Patient Global Impression of Change Scale
Time Frame
3 months, 12 months
Title
health related quality of life
Description
Short Form 36 Health Survey
Time Frame
3 months, 12 onths
Title
pain interference
Description
brief pain inventory, interference scale
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Stein, MD
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University/Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Hennepin Healthcare
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35777696
Citation
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.
Results Reference
derived
Learn more about this trial
Treating Comorbid Pain and Depression in HIV+ Individuals
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