Trial Outcomes & Findings for Equity Using Interventions for Pain and Depression - Pilot Study (NCT NCT05695209)

Last Updated: 2025-06-11

Results Overview

The pain interference score averages seven ratings, 0 (does not interfere) to 10 (interferes completely), of interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

3 months

Results posted on

2025-06-11

Participant Flow

Potentially eligible participants (primary care patients within an academic, safety-net healthcare system) were identified through electronic medical records and sent a letter and brochure describing the study. A study team member followed up with a phone call to assess interest and, if interested, screen for eligibility.

Participant milestones

Participant milestones
Measure	Coaching and Decision Aid Individual coaching sessions and Decision Aid Coaching and Decision Aid: Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents	Control Wait-list control group
3-months STARTED	16	14
3-months COMPLETED	14	13
3-months NOT COMPLETED	2	1
6-months STARTED	14	14
6-months COMPLETED	13	13
6-months NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Coaching and Decision Aid Individual coaching sessions and Decision Aid Coaching and Decision Aid: Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents	Control Wait-list control group
3-months Withdrawal by Subject	2	0
3-months Unable to contact for 3-month data collection	0	1
6-months Lost to Follow-up	1	1

Baseline Characteristics

Equity Using Interventions for Pain and Depression - Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Coaching and Decision Aid n=16 Participants Individual coaching sessions and Decision Aid Coaching and Decision Aid: Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents	Control n=14 Participants Wait-list control group	Total n=30 Participants Total of all reporting groups
Age, Continuous	59.9 years STANDARD_DEVIATION 14.3 • n=5 Participants	61.3 years STANDARD_DEVIATION 13.4 • n=7 Participants	60.6 years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex/Gender, Customized Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex/Gender, Customized Female	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	14 participants n=7 Participants	30 participants n=5 Participants
Highest level of education completed Some Secondary School or High School Education	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Highest level of education completed High School (or Secondary School) Degree Complete	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Highest level of education completed Associate's or Technical Degree Complete	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Highest level of education completed College/Baccalaureate/Doctoral or Postgraduate Education	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Current relationship status Divorced/Separated	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Current relationship status Married/Domestic Partner	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Current relationship status Never Married	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Current relationship status Widowed	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Current relationship status Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Employment status Full-time employment	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Employment status Not employed	13 Participants n=5 Participants	7 Participants n=7 Participants	20 Participants n=5 Participants
Employment status Part-time employment	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Household income Comfortable	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Household income Just enough to make ends meet	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Household income Not enough to make ends meet	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Pain duration	140.6 months STANDARD_DEVIATION 117.2 • n=5 Participants	146.2 months STANDARD_DEVIATION 165.9 • n=7 Participants	143.2 months STANDARD_DEVIATION 139.5 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	Coaching and Decision Aid n=14 Participants Individual coaching sessions and Decision Aid Coaching and Decision Aid: Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents	Control n=13 Participants Wait-list control group
Change From Baseline Brief Pain Inventory (BPI) Interference Scale at 3 Months	-1.02 units on a scale Standard Deviation 1.87	-0.30 units on a scale Standard Deviation 2.24

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Coaching and Decision Aid n=13 Participants Individual coaching sessions and Decision Aid Coaching and Decision Aid: Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents	Control n=12 Participants Wait-list control group
Change From Baseline Brief Pain Inventory (BPI) Interference Scale at 6 Months	-1.75 units on a scale Standard Deviation 2.28	-1.14 units on a scale Standard Deviation 1.51

SECONDARY outcome

Timeframe: 3 months

The PHQ-8 is a widely-used, validated 8-item measure of depression severity. The PHQ-8 is scored by assigning a value of 0 (not at all) to 3 (nearly every day) to each of the 8 items, with a total score ranging from 0 to 24. Higher scores indicate worse depression severity.

Outcome measures

Outcome measures
Measure	Coaching and Decision Aid n=14 Participants Individual coaching sessions and Decision Aid Coaching and Decision Aid: Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents	Control n=13 Participants Wait-list control group
Change From Baseline Patient Health Questionnaire (PHQ)-8 at 3 Months	-2.36 units on a scale Standard Deviation 5.57	-0.77 units on a scale Standard Deviation 4.44

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Coaching and Decision Aid n=13 Participants Individual coaching sessions and Decision Aid Coaching and Decision Aid: Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents	Control n=13 Participants Wait-list control group
Change From Baseline Patient Health Questionnaire (PHQ)-8 at 6 Months	-2.15 units on a scale Standard Deviation 4.18	-0.46 units on a scale Standard Deviation 4.75

SECONDARY outcome

Timeframe: 3 months

Anxiety will be measured with the 7 item Generalized Anxiety Disorder Scale (GAD-7). The GAD-7 is scored by assigning a value of 0 to 3 to each of the seven items, with a total score ranging from 0 to 21. The total score indicates the severity of anxiety symptoms (higher scores indicating a worse outcome).

Outcome measures

Outcome measures
Measure	Coaching and Decision Aid n=14 Participants Individual coaching sessions and Decision Aid Coaching and Decision Aid: Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents	Control n=13 Participants Wait-list control group
Change From Baseline Generalized Anxiety Disorder Scale (GAD-7) at 3 Months	-3.29 units on a scale Standard Deviation 5.01	-0.08 units on a scale Standard Deviation 6.30

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Coaching and Decision Aid n=13 Participants Individual coaching sessions and Decision Aid Coaching and Decision Aid: Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents	Control n=13 Participants Wait-list control group
Change From Baseline Generalized Anxiety Disorder Scale (GAD-7) at 6 Months	-3.23 units on a scale Standard Deviation 3.75	-0.23 units on a scale Standard Deviation 4.40

SECONDARY outcome

Timeframe: 3 months

The Pain Catastrophizing Scale is a 13-item scale that assesses catastrophizing-a cognitive-emotional factor that predicts poor treatment response. The scale uses a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time) for each item with a total score ranging from 0 to 52. Higher scores indicate a worse outcome.

Outcome measures

Outcome measures
Measure	Coaching and Decision Aid n=13 Participants Individual coaching sessions and Decision Aid Coaching and Decision Aid: Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents	Control n=13 Participants Wait-list control group
Change From Baseline Pain Catastrophizing Scale at 3 Months	-4.31 units on a scale Standard Deviation 11.26	3.54 units on a scale Standard Deviation 8.78

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Coaching and Decision Aid n=13 Participants Individual coaching sessions and Decision Aid Coaching and Decision Aid: Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents	Control n=13 Participants Wait-list control group
Change From Baseline Pain Catastrophizing Scale at 6 Months	-5.00 units on a scale Standard Deviation 13.39	-2.12 units on a scale Standard Deviation 12.01

SECONDARY outcome

Timeframe: 3 months

Patient engagement will be measured with the 12-item Altarum Consumer Engagement (ACE) Measure, which has 3 subscales: 1) commitment to manage one's health, 2) informed choice, and 3) confidence to participate in treatment decisions. Each item is assessed on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree) with a total score ranging from 0 to 48. Higher scores indicate greater engagement.

Outcome measures

Outcome measures
Measure	Coaching and Decision Aid n=13 Participants Individual coaching sessions and Decision Aid Coaching and Decision Aid: Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents	Control n=13 Participants Wait-list control group
Change From Baseline Altarum Consumer Engagement (ACE) Measure at 3 Months	2.64 units on a scale Standard Deviation 8.96	-2.04 units on a scale Standard Deviation 9.16

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Coaching and Decision Aid n=13 Participants Individual coaching sessions and Decision Aid Coaching and Decision Aid: Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents	Control n=13 Participants Wait-list control group
Change From Baseline Altarum Consumer Engagement (ACE) Measure at 6 Months	4.29 units on a scale Standard Deviation 7.16	-0.24 units on a scale Standard Deviation 10.93

SECONDARY outcome

Timeframe: 3 months

The NSCAP asks about 9 nonpharmacological treatment (NPT) modalities and assesses details of use such as frequency, location/source of service, and patients' judgments of effectiveness. Space is also provided for other NPTs that are used but not listed. The number of modalities for which patients answer "yes" will be summed for analyses.

Outcome measures

Outcome measures
Measure	Coaching and Decision Aid n=13 Participants Individual coaching sessions and Decision Aid Coaching and Decision Aid: Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents	Control n=13 Participants Wait-list control group
Change From Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 3 Months	0.23 counts of NPTs Standard Deviation 1.96	-0.46 counts of NPTs Standard Deviation 1.61

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Coaching and Decision Aid n=13 Participants Individual coaching sessions and Decision Aid Coaching and Decision Aid: Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents	Control n=13 Participants Wait-list control group
Change From Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 6 Months	0.38 counts of NPTs Standard Deviation 1.50	0.54 counts of NPTs Standard Deviation 1.94

SECONDARY outcome

Timeframe: 3 months

Communication self-efficacy will be measured with this 5-item scale that measures patients' self-efficacy in obtaining medical information and getting their most important health concern discussed in a clinic visit. Higher scores indicate greater communication self-efficacy. The scale uses ratings from 0 (not at all confident) to 10 (extremely confident) for each item with a total score ranging from 0 to 50.

Outcome measures

Outcome measures
Measure	Coaching and Decision Aid n=13 Participants Individual coaching sessions and Decision Aid Coaching and Decision Aid: Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents	Control n=13 Participants Wait-list control group
Change From Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 3 Months	0.08 score on a scale Standard Deviation 5.45	2.08 score on a scale Standard Deviation 10.90

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Coaching and Decision Aid n=13 Participants Individual coaching sessions and Decision Aid Coaching and Decision Aid: Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents	Control n=13 Participants Wait-list control group
Change From Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 6 Months	1.46 units on a scale Standard Deviation 4.41	0.15 units on a scale Standard Deviation 8.71

SECONDARY outcome

Timeframe: 3 months

Shared decision making will be measured with CollaboRATE, a 3-item measure assessing provider effort from the patient's perspective to engage in shared-decision making during a recent appointment. The CollaboRATE scale uses a 5-point Likert scale, ranging from "No effort was made (0)" to "Every effort was made (4)" for each item with a total score ranging from 0 to 12. Higher scores indicate higher provider effort from the patient's perspective to engage in shared-decision making.

Outcome measures

Outcome measures
Measure	Coaching and Decision Aid n=13 Participants Individual coaching sessions and Decision Aid Coaching and Decision Aid: Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents	Control n=13 Participants Wait-list control group
Change From Baseline CollaboRATE at 3 Months	0.26 units on a scale Standard Deviation 0.47	-0.13 units on a scale Standard Deviation 0.91

SECONDARY outcome

Timeframe: 6 months

Shared decision making will be measured with CollaboRATE, a 3-item measure assessing provider effort from the patient's perspective to engage in shared-decision making during a recent appointment. The CollaboRATE scale uses a 5-point Likert scale, ranging from "No effort was made (0)" to "Every effort was made (4)" or each item with a total score ranging from 0 to 12. Higher scores indicate higher provider effort from the patient's perspective to engage in shared-decision making.

Outcome measures

Outcome measures
Measure	Coaching and Decision Aid n=13 Participants Individual coaching sessions and Decision Aid Coaching and Decision Aid: Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents	Control n=13 Participants Wait-list control group
Change From Baseline CollaboRATE at 6 Months	0.26 units on a scale Standard Deviation 0.71	-0.05 units on a scale Standard Deviation 0.49

SECONDARY outcome

Timeframe: 3 months

The Working Alliance Inventory (WAI) Client Short Form assesses patient-provider agreement on treatment goals, collaboration to achieve these goals, and degree of emotional bond (liking and trust) between patients and providers. The scale uses ratings from 1 (Never) to 7 (Always) for each item with a total score ranging from 12 to 84. Higher scores indicate greater alliance between patient and provider.

Outcome measures

Outcome measures
Measure	Coaching and Decision Aid n=13 Participants Individual coaching sessions and Decision Aid Coaching and Decision Aid: Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents	Control n=13 Participants Wait-list control group
Change From Baseline Working Alliance Inventory (WAI) Client Short Form at 3 Months	3.67 units on a scale Standard Deviation 13.34	-5.54 units on a scale Standard Deviation 13.08

SECONDARY outcome

Timeframe: 6 months

The Working Alliance Inventory (WAI) Client Short Form assesses patient-provider agreement on treatment goals, collaboration to achieve these goals, and degree of emotional bond (liking and trust) between patients and providers. The scale uses ratings from 1 (Never) to 7 (Always) or each item with a total score ranging from 12 to 84. Higher scores indicate greater alliance between patient and provider.

Outcome measures

Outcome measures
Measure	Coaching and Decision Aid n=13 Participants Individual coaching sessions and Decision Aid Coaching and Decision Aid: Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents	Control n=13 Participants Wait-list control group
Change From Baseline Working Alliance Inventory (WAI) Client Short Form at 6 Months	5.69 units on a scale Standard Deviation 9.78	-2.38 units on a scale Standard Deviation 8.05

Adverse Events

Coaching and Decision Aid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control: Received Decision Aid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control: Usual Care Without Decision Aid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator

Indiana University

Phone: 317-278-3154

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place