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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health Education | Placebo Comparator | 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. |
|
| HIVPASS | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIVPASS | Behavioral | The 7-session HIVPASS intervention is provided to individuals randomized to the HIVPASS study arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| pain interference | Brief pain inventory, interference scale | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| depression | Quick Inventory of depression symptoms | 3 months; 12 months |
| activity level | Assessed with actigraphy | 3 months; 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Stein, MD | Butler Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University/Boston Medical Center | Boston | Massachusetts | 02118 | United States | ||
| Hennepin Healthcare |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36799731 | Derived | 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. | |
| 35777696 |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Health Education | Behavioral | The 7-sessions of Health Education is provided to individuals randomized to the Health Education study arm. |
|
| anxiety | State-Trait Anxiety Inventory | 3 months; 12 months |
| viral load | 3 months, 12 months |
| ART adherence | AIDS Clinical Trial Group questionnaire | 3 months, 12 months |
| perception of global improvement | Patient Global Impression of Change Scale | 3 months, 12 months |
| health related quality of life | Short Form 36 Health Survey | 3 months, 12 onths |
| pain interference | brief pain inventory, interference scale | 12 months |
| Minneapolis |
| Minnesota |
| 55415 |
| United States |
| Butler Hospital | Providence | Rhode Island | 02906 | United States |
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| Derived |
| 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |