Treating Chronic Pain and Depression in HIV+ Patients in... | NCT01735708

ID	Type	Description	Link
R21NR013438	U.S. NIH Grant/Contract		View source

Treating Chronic Pain and Depression in HIV+ Patients in... | NCT01735708 | Trialant

Sponsor/Collaborators Module

Name	Class
Brown University	OTHER
National Institute of Nursing Research (NINR)	NIH

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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.	Behavioral: HIVPASS

Name	Type	Description	Arm Group Labels	Other Names
HIVPASS	Behavioral		HIVPASS Intervention
Health Education

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	3 months

Secondary Outcomes

Measure	Description	Time Frame
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.	12 months
Quick Inventory of Depression Symptoms at 3 Months

Contacts/Locations Module

Name	Affiliation	Role
Michael Stein, MD	Butler Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Butler Hospital		Providence	Rhode Island	02906	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27115400	Derived	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.

Arm/Group Information

ID	Title	Description
FG000	Health Education	Participants in the Health Education arm will receive 7 individual sessions, each of which will focus on a different health education topic.
FG001	HIVPASS Intervention	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.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00095 subjects FG00192 subjects
Month 3 Assessment		FG00079 subjects FG00179 subjects
COMPLETED		FG00084 subjects FG00179 subjects
NOT COMPLETED		FG00011 subjects FG00113 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Health Education	Participants in the Health Education arm will receive 7 individual sessions, each of which will focus on a different health education topic.
BG001	HIVPASS Intervention

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Posted

Mean

Standard Deviation

score on a scale

3 months

ID	Title	Description
OG000	Health Education	Participants in the Health Education arm will receive 7 individual sessions, each of which will focus on a different health education topic.
OG001	HIVPASS Intervention	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Health Education	Participants in the Health Education arm will receive 7 individual sessions, each of which will focus on a different health education topic.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Acidosis	Metabolism and nutrition disorders		Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Arthralgia	Musculoskeletal and connective tissue disorders		Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Lisa Uebelacker	Butler Hospital	401-455-6381		luebelacker@butler.org

Condition Browse Module

ID	Term
D003863	Depression
D010146	Pain

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00012 BG00113 BG00225
Not Hispanic or Latino	BG00083 BG00179 BG002162
Unknown or Not Reported	BG0000 BG0010 BG0020

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0003 BG0016 BG0029
Asian	BG0000 BG0010 BG0020
Native Hawaiian or Other Pacific Islander	BG0000 BG0011 BG0021
Black or African American	BG00034 BG00127 BG00261
White	BG00037 BG00135 BG00272
More than one race	BG00016 BG00112 BG00228
Unknown or Not Reported	BG0005 BG00111 BG00216

Brief Pain Inventory - Interference Scale

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.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG0006.44± 2.15 BG0016.16± 1.98 BG0026.30± 1.56

Worst pain severity, past week

Title: worst pain severity, past week. Measures: self-report of worst pain in the past week. Scale range: 0-10. Higher scores represent a worse outcome.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG0008.27± 1.52 BG0018.14± 1.61 BG0028.21± 2.07

Average pain severity, past week

Title: average pain severity, past week. Measures: self-report of average pain level in the past week. Scale range: 0-10. Higher scores represent a worse outcome.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG0006.37± 1.88 BG0016.48± 1.87 BG0026.43± 1.87

Quick Inventory of Depressive Symptoms

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.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00014.4± 2.93 BG00114.0± 3.04 BG00214.2± 2.99

PROMIS Anxiety

Title: Patient-Reported Outcome Measurement Information System (PROMIS) Anxiety Scale.

Abbreviation: PROMIS Anxiety. Measures: self-report of anxiety symptom severity. Scale range: 8-40. Higher scores represent a worse outcome.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00024.5± 6.44 BG00124.5± 6.63 BG00224.5± 6.39

Antiretroviral therapy (ART) adherence

Antiretroviral Therapy (ART) Adherence. Measures: self-report of percent adherence to ART within the past month. Range: 0-100%. Higher scores represent better adherence.

Mean

Standard Deviation

% Adherence

Title

Denominators

Categories

Title	Measurements
	BG00091.5± 18.4 BG00195.1± 0.5 BG00293.3± 15.1

SF-36 Physical Health component

36-item Short Form Survey -- Physical Health Component. Abbreviation: SF-36 Physical Health Component. Measures: quality of life related to physical health, via self-report. Range in this sample: -3.41 - 1.36. Higher scores represent better functioning.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG000-1.67± 0.94 BG001-1.42± 1.07 BG002-1.55± 1.01

SF-36 Mental Health component

36-item Short Form Survey-- Mental Health Component. Abbreviation: SF-36 Mental Health Component. Measures: quality of life related to mental health, via self-report. Range in this sample: -4.48 - 1.36. Higher scores represent better functioning.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG000-1.83± 1.09 BG001-1.77± 1.21 BG002-1.80± 1.15

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Models Analysis	Standard errors were based on robust Huber-White variance estimator.	0.008	A priori threshold for significance was two-tailed p = .05.	Mean Difference (Net)	-1.31	Standard Error of the Mean	0.493	2-Sided	95	-2.28	-0.34			standard error of difference in means		Superiority	ITT analysis using multiple imputation by chained equation with 50 fully populated data sets.

Secondary

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.

Posted

Mean

Standard Deviation

score on a scale

12 months

ID	Title	Description
OG000	Health Education	Participants in the Health Education arm will receive 7 individual sessions, each of which will focus on a different health education topic.
OG001	HIVPASS Intervention	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.

Units	Counts
Participants	OG00084 OG00179

Title

Denominators

Categories

Title	Measurements
	OG0004.74± 3.12 OG0014.95± 3.01

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Models Analysis	Standard errors were based on robust Huber-White variance estimator.	0.251	A priori threshold for significance was two-tailed p = .05.	Mean Difference (Net)	-0.57	Standard Error of the Mean	0.495	2-Sided	95	-1.53	0.40					Superiority	Intent to treat analysis using multiple imputation by chained equations with 50 fully populated data sets.

Secondary

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.

Posted

Mean

Standard Deviation

score on a scale

3 months

ID	Title	Description
OG000	Health Education	Participants in the Health Education arm will receive 7 individual sessions, each of which will focus on a different health education topic. Health Education
OG001	HIVPASS Intervention	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. HIVPASS

Units	Counts
Participants	OG00079 OG00179

Title

Denominators

Categories

Title	Measurements
	OG00010.35± 4.81 OG00110.25± 4.81

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Models Analysis	Standard errors were based on robust Huber-White variance estimator.	0.844	A priori threshold for significance was two-tailed p = .05.	Mean Difference (Net)	0.15	Standard Error of the Mean	0.750	2-Sided	95	-1.32	1.61			Standard error of difference in means.		Superiority	Intent to treat analysis using multiple imputation by chained equations with 50 fully populated data sets.

Secondary

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.

Posted

Mean

Standard Deviation

score on a scale

12 months

ID	Title	Description
OG000	Health Education	Participants in the Health Education arm will receive 7 individual sessions, each of which will focus on a different health education topic.
OG001	HIVPASS Intervention	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.

Units	Counts
Participants	OG00084 OG00179

Title

Denominators

Categories

Title	Measurements
	OG00010.18± 5.05 OG0019.80± 5.60

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Models Analysis	Standard errors were based on robust Huber-White variance estimator.	0.545	A priori threshold for significance was two-tailed p = .05.	Mean Difference (Final Values)	-0.51	Standard Error of the Mean	0.836	2-Sided	95	-2.18	1.15			Standard error of difference in means.		Superiority	Intent to treat analysis using multiple imputation by chained equations with 50 fully populated data sets.