Chronic PainEQUIPD-PilotNCT05695209
Equity Using Interventions for Pain and Depression - Pilot Study
A study testing Coaching and Decision Aid in people with Chronic Pain and Depression, run by Indiana University at 1 site in United States.
Trial summary
This project is part of the NIH Helping to End Addiction Long-term (HEAL) initiative (https://heal.nih.gov/). This pilot randomized controlled trial (RCT) is part of phase 1 of a two-phase, 5-year project with the overarching goal of testing a decision aid (DA)/coaching intervention, tailored to Black patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Depression, Health Equity
- What is being tested?
- Coaching and Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2023to 23 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients must:
- have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, shoulder) for ≥3 months,
- have at least moderate pain intensity and interference with function, defined by a score ≥4 (possible range: 0-10) on the Pain, Enjoyment of Life and General Activity scale (PEG), a 3-item measure of pain intensity, interference with enjoyment of life, and interference with general activity,
- have at least mild depression, defined as PHQ-8 score ≥5,
- identify as Black or African American,
- have consistent access to a telephone,
- indicate openness to new pain treatments, and
- have a scheduled appointment with their PCP in the next approximate 2-4 months
Who cannot join
- Patients are excluded:
- if previously participated in the PI's past pilot study (IRB #12885) or participation as a Patient Engagement Panel member for this project,
- if medical records indicate severe medical conditions likely precluding participation (e.g., NY Heart Association Class III or IV heart failure), or
- if the eligibility screener reveals (1) active suicidal ideation, or (2) severe hearing/speech or cognitive impairment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Eskenazi Health Primary Care
Indianapolis, Indiana, 46254
About this study
Official title: Equity Using Interventions for Pain and Depression (EQUIPD) - Phase 1
This project is part of the NIH Helping to End Addiction Long-term (HEAL) initiative (https://heal.nih.gov/). This pilot randomized controlled trial (RCT) is part of phase 1 of a two-phase, 5-year project with the overarching goal of testing a decision aid (DA)/coaching intervention, tailored to Black patients with comorbid chronic pain and depression, to encourage use of and adherence to nonpharmacological pain treatments (NPTs).
This 2-arm pilot trial randomized 30 Black patients with comorbid chronic musculoskeletal pain and depression in primary care from an urban safety-net health system. After the baseline assessment, patients randomized to the intervention were asked to participate in 4 coaching sessions over approximately 12 weeks. Sessions used Motivational Interviewing principles to foster openness to NPTs and self-efficacy by helping patients identify their goals and priorities, understand their NPT options, prepare them to discuss and choose options with their primary care providers (PCPs), and reinforce these choices to foster maintenance of these changes. DA contents were integrated into these sessions, which facilitated discussion of these options with their PCP. The first 3 sessions ideally took place prior to the patient's next scheduled PCP visit; the final session occurred after this visit. Assessments were conducted at baseline, 3 months (i.e., after completing the final coaching session), and 6 months.
Patients randomized to the wait-list control group received usual care (in addition to study assessments at baseline, 3 months, and 6 months). After completing the final assessment, they were given the DA and offered a 20-minute coaching session to walk them through it (patients could decline the coaching session).
- Conditions
- Chronic Pain, Depression, Health Equity
- Being tested
- Coaching and Decision Aid
- Keywords
- chronic pain, depression, health equity, shared decision making, decision aid
- Medical subject headings
- Chronic Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coaching and Decision AidBehavioural
Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents
| Study group | Role | What they receive |
|---|---|---|
| Coaching and Decision Aid | Experimental | Individual coaching sessions and Decision Aid Receives: Behavioral: Coaching and Decision Aid |
| Control | No intervention | Wait-list control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Brief Pain Inventory (BPI) Interference Scale at 3 Months
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.
Measured: 3 months
Change From Baseline Brief Pain Inventory (BPI) Interference Scale at 6 Months
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.
Measured: 6 months
Secondary outcomes (16)
Change From Baseline Patient Health Questionnaire (PHQ)-8 at 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.
Measured: 3 months
Change From Baseline Patient Health Questionnaire (PHQ)-8 at 6 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.
Measured: 6 months
Change From Baseline Generalized Anxiety Disorder Scale (GAD-7) at 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).
Measured: 3 months
Change From Baseline Generalized Anxiety Disorder Scale (GAD-7) at 6 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).
Measured: 6 months
Change From Baseline Pain Catastrophizing Scale at 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.
Measured: 3 months
Change From Baseline Pain Catastrophizing Scale at 6 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.
Measured: 6 months
Change From Baseline Altarum Consumer Engagement (ACE) Measure at 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.
Measured: 3 months
Change From Baseline Altarum Consumer Engagement (ACE) Measure at 6 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.
Measured: 6 months
Change From Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 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.
Measured: 3 months
Change From Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 6 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.
Measured: 6 months
Change From Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 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.
Measured: 3 months
Change From Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 6 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.
Measured: 6 months
Change From Baseline CollaboRATE at 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.
Measured: 3 months
Change From Baseline CollaboRATE at 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.
Measured: 6 months
Change From Baseline Working Alliance Inventory (WAI) Client Short Form at 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.
Measured: 3 months
Change From Baseline Working Alliance Inventory (WAI) Client Short Form at 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start22 Jun 2023
- Primary completion23 Apr 2024
- Study completion23 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Marianne S. Matthias, Indiana University
- Investigators
- Marianne Matthias, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695209
- Sponsor's protocol ID
- 16571
- Other IDs
- R61NR020845
- Acronym
- EQUIPD-Pilot
- Status last verified
- Jun 2025
- First submitted
- 11 Jan 2023
- Last updated
- 11 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: NIH intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing. All HEAL Initiative award recipients, regardless of the amount of direct costs requested for any one year, are required to comply with the HEAL Public Access and Data Sharing Policy, which also aligns with the NIH Policy for Data Management and Sharing (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html). HEAL award recipients must following all requirements and timelines developed through the HEAL Initiative Data Ecosystem, as described in HEAL's compliance guidance (https://heal.nih.gov/data/complying-heal-data-sharing-policy).
Publications
Matthias MS, Burgess DJ, Daggy JK, Donnelly CE, Flores P, Fowler NR, Garabrant J, Henry N, Henry SG, Huffman M, Kavuri PJ, Ofner S, Perry C, Rand KL, Robles M, Salyers MP, Taylor SL, Hirsh AT. Equity Using Interventions for Pain and Depression (EQUIPD): A pilot randomized trial. J Pain. 2025 Apr;29:105353. doi: 10.1016/j.jpain.2025.105353. Epub 2025 Feb 25.
PubMed 40010678
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Equity Using Interventions for Pain and Depression (EQUIPD) - Phase 1
- ClinicalTrials.gov ID
- NCT05695209
- Acronym / sponsor ID
- EQUIPD-Pilot / 16571
- Conditions
- Chronic Pain, Depression, Health Equity
- Keywords
- chronic pain, depression, health equity, shared decision making, decision aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 23 Jan 2023 (actual)
- Results
- Posted 11 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is part of the NIH Helping to End Addiction Long-term (HEAL) initiative (https://heal.nih.gov/). This pilot randomized controlled trial (RCT) is part of phase 1 of a two-phase, 5-year project with the overarching goal of testing a decision aid (DA)/coaching intervention, tailored to Black patients with comorbid chronic pain and depression, to encourage use of and adherence to nonpharmacological pain treatments (NPTs).
This 2-arm pilot trial randomized 30 Black patients with comorbid chronic musculoskeletal pain and depression in primary care from an urban safety-net health system. After the baseline assessment, patients randomized to the intervention were asked to participate in 4 coaching sessions over approximately 12 weeks. Sessions used Motivational Interviewing principles to foster openness to NPTs and self-efficacy by helping patients identify their goals and priorities, understand their NPT options, prepare them to discuss and choose options with their primary care providers (PCPs), and reinforce these choices to foster maintenance of these changes. DA contents were integrated into these sessions, which facilitated discussion of these options with their PCP. The first 3 sessions ideally took place prior to the patient's next scheduled PCP visit; the final session occurred after this visit. Assessments were conducted at baseline, 3 months (i.e., after completing the final coaching session), and 6 months.
Patients randomized to the wait-list control group received usual care (in addition to study assessments at baseline, 3 months, and 6 months). After completing the final assessment, they were given the DA and offered a 20-minute coaching session to walk them through it (patients could decline the coaching session).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coaching and Decision Aid | Experimental | Behavioral: Coaching and Decision AidIndividual coaching sessions and Decision Aid |
| Control | No intervention | –Wait-list control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, shoulder) for ≥3 months,
- have at least moderate pain intensity and interference with function, defined by a score ≥4 (possible range: 0-10) on the Pain, Enjoyment of Life and General Activity scale (PEG), a 3-item measure of pain intensity, interference with enjoyment of life, and interference with general activity,
- have at least mild depression, defined as PHQ-8 score ≥5,
- identify as Black or African American,
- have consistent access to a telephone,
Key exclusion criteria (4 listed)
- if previously participated in the PI's past pilot study (IRB #12885) or participation as a Patient Engagement Panel member for this project,
- if medical records indicate severe medical conditions likely precluding participation (e.g., NY Heart Association Class III or IV heart failure), or
- if the eligibility screener reveals (1) active suicidal ideation, or (2) severe hearing/speech or cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coaching and Decision AidFour (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents | Behavioural | Coaching and Decision Aid |
Primary outcome
Change From Baseline Brief Pain Inventory (BPI) Interference Scale at 3 Months
Time frame: 3 months
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.
Change From Baseline Brief Pain Inventory (BPI) Interference Scale at 6 Months
Time frame: 6 months
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.
16 secondary outcomes
Change From Baseline Patient Health Questionnaire (PHQ)-8 at 3 Months
Time frame: 3 months
Change From Baseline Patient Health Questionnaire (PHQ)-8 at 6 Months
Time frame: 6 months
Change From Baseline Generalized Anxiety Disorder Scale (GAD-7) at 3 Months
Time frame: 3 months
Change From Baseline Generalized Anxiety Disorder Scale (GAD-7) at 6 Months
Time frame: 6 months
Change From Baseline Pain Catastrophizing Scale at 3 Months
Time frame: 3 months
Change From Baseline Pain Catastrophizing Scale at 6 Months
Time frame: 6 months
Change From Baseline Altarum Consumer Engagement (ACE) Measure at 3 Months
Time frame: 3 months
Change From Baseline Altarum Consumer Engagement (ACE) Measure at 6 Months
Time frame: 6 months
Change From Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 3 Months
Time frame: 3 months
Change From Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 6 Months
Time frame: 6 months
Change From Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 3 Months
Time frame: 3 months
Change From Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 6 Months
Time frame: 6 months
Change From Baseline CollaboRATE at 3 Months
Time frame: 3 months
Change From Baseline CollaboRATE at 6 Months
Time frame: 6 months
Change From Baseline Working Alliance Inventory (WAI) Client Short Form at 3 Months
Time frame: 3 months
Change From Baseline Working Alliance Inventory (WAI) Client Short Form at 6 Months
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40010678Matthias MS, Burgess DJ, Daggy JK, Donnelly CE, Flores P, Fowler NR, Garabrant J, Henry N, Henry SG, Huffman M, Kavuri PJ, Ofner S, Perry C, Rand KL, Robles M, Salyers MP, Taylor SL, Hirsh AT. Equity Using Interventions for Pain and Depression (EQUIPD): A pilot randomized trial. J Pain. 2025 Apr;29:105353. doi: 10.1016/j.jpain.2025.105353. Epub 2025 Feb 25.
- Individual participant dataSharing planned: Yes. NIH intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing. All HEAL Initiative award recipients, regardless of the amount of direct costs requested for any one year, are required to comply with the HEAL Public Access and Data Sharing Policy, which also aligns with the NIH Policy for Data Management and Sharing (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html). HEAL award recipients must following all requirements and timelines developed through the HEAL Initiative Data Ecosystem, as described in HEAL's compliance guidance (https://heal.nih.gov/data/complying-heal-data-sharing-policy).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne Matthias, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coaching and Decision Aid in people with Chronic Pain and Depression, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline Brief Pain Inventory (BPI) Interference Scale at 3 Months (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05695209, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.