Chronic PainEQUIPDNCT06500780
Equipping Patients Using Interventions for Pain and Depression
A study testing Coaching and Decision Aid in people with Chronic Pain and Musculoskeletal Pain, 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 randomized controlled trial (RCT) is phase 2 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Musculoskeletal Pain, Depression
- 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
- 304 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2024to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 or be willing to schedule one
Who cannot join
- Patients are excluded:
- if previously participated in Dr. Matthias' past pilot study (IRB #12885), the pilot RCT for this project (IRB #16571), or are participating as a Patient Engagement Panel member for this project (Aim 1.1),
- if the eligibility screener or medical records indicate severe medical conditions likely precluding participation (e.g. stroke in the last 6 months, hospitalized with congestive heart failure or a heart attack in the last 6 months, cancer other than skin cancer and receiving active treatment), or
- if the eligibility screener or medical records reveal (1) active suicidal ideation, or (2) severe hearing/speech or cognitive impairment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Eskenazi Health Primary Care
Indianapolis, Indiana, 46254
Research Specialist, 317-274-9402, equipd@regenstrief.org
Adam T Hirsh, PhD
About this study
Official title: Equipping Patients Using Interventions for Pain and Depression (EQUIPD) - Phase 2
This project is part of the NIH Helping to End Addiction Long-term (HEAL) initiative (https://heal.nih.gov/). This randomized controlled trial (RCT) is phase 2 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 trial will randomize 304 patients with comorbid chronic musculoskeletal pain and depression in primary care from an urban safety-net health system (Eskenazi). After the baseline assessment, patients randomized to the intervention will be asked to participate in 4 coaching sessions over approximately 12 weeks. Sessions will use 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 will be integrated into these sessions, which will facilitate discussion of these options with their PCP. The first 3 sessions take place prior to the patient's next scheduled PCP visit; the final session occurs after this visit. Assessments will be conducted at baseline, 3 months (i.e., after completing the final coaching session), and 6 months.
Patients randomized to the wait-list control group will receive usual care (in addition to study assessments at baseline, 3 months, and 6 months). After completing the final assessment, they will then be given the DA and offered a 20-minute coaching session to walk them through it.
- Conditions
- Chronic Pain, Musculoskeletal Pain, Depression, Health Equity
- Being tested
- Coaching and Decision Aid
- Keywords
- chronic pain, depression, health equity, shared decision making, decision aid, depressive symptoms
- Medical subject headings
- Chronic Pain, Musculoskeletal 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 | Intervention group (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 (completely interferes).
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 (completely interferes).
Measured: 6 months
Change from Baseline Patient Health Questionnaire (PHQ)-8 at 3 months
The Patient Health Questionnaire (PHQ)-8 is a widely-used, validated 8-item measure of depression severity that uses a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day).
Measured: 3 months
Change from Baseline Patient Health Questionnaire (PHQ)-8 at 6 months
The Patient Health Questionnaire (PHQ)-8 is a widely-used, validated 8-item measure of depression severity that uses a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day).
Measured: 6 months
Secondary outcomes (10)
Change from Baseline Generalized Anxiety Disorder (GAD)-7 at 3 months
Anxiety will be measured with the 7 item Generalized Anxiety Disorder (GAD)-7 that uses a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day).
Measured: 3 months
Change from Baseline Generalized Anxiety Disorder (GAD)-7 at 6 months
Anxiety will be measured with the 7 item Generalized Anxiety Disorder (GAD)-7 that uses a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day).
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).
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).
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 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. Items are assessed on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree).
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. Items are assessed on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree).
Measured: 6 months
Change from Baseline Decisional Conflict Scale (DCS) at 3 months
Decisional conflict will be measured with the 16-item Decisional Conflict Scale that measures personal perceptions of a) uncertainty in choosing options, b) modifiable factors contributing to uncertainty, and c) effective decision making on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree).
Measured: 3 months
Change from Baseline Decisional Conflict Scale (DCS) at 6 months
Decisional conflict will be measured with the 16-item Decisional Conflict Scale that measures personal perceptions of a) uncertainty in choosing options, b) modifiable factors contributing to uncertainty, and c) effective decision making on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree).
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 posted15 Jul 2024
- Study start13 Aug 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Adam Todd Hirsh, Indiana University
- Investigators
- Adam T Hirsh, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500780
- Sponsor's protocol ID
- 22412
- Other IDs
- 4R33NR020845-02
- Acronym
- EQUIPD
- Status last verified
- Jun 2026
- First submitted
- 8 Jul 2024
- Last updated
- 9 Jun 2026
- Results posted
- No
- 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).
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Equipping Patients Using Interventions for Pain and Depression (EQUIPD) - Phase 2
- ClinicalTrials.gov ID
- NCT06500780
- Acronym / sponsor ID
- EQUIPD / 22412
- Conditions
- Chronic Pain, Musculoskeletal Pain, Depression, Health Equity
- Keywords
- chronic pain, depression, health equity, shared decision making, decision aid, depressive symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
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 randomized controlled trial (RCT) is phase 2 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 trial will randomize 304 patients with comorbid chronic musculoskeletal pain and depression in primary care from an urban safety-net health system (Eskenazi). After the baseline assessment, patients randomized to the intervention will be asked to participate in 4 coaching sessions over approximately 12 weeks. Sessions will use 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 will be integrated into these sessions, which will facilitate discussion of these options with their PCP. The first 3 sessions take place prior to the patient's next scheduled PCP visit; the final session occurs after this visit. Assessments will be conducted at baseline, 3 months (i.e., after completing the final coaching session), and 6 months.
Patients randomized to the wait-list control group will receive usual care (in addition to study assessments at baseline, 3 months, and 6 months). After completing the final assessment, they will then be given the DA and offered a 20-minute coaching session to walk them through it.
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 AidIntervention group (Individual 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)
- 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,
Key exclusion criteria (4 listed)
- if previously participated in Dr. Matthias' past pilot study (IRB #12885), the pilot RCT for this project (IRB #16571), or are participating as a Patient Engagement Panel member for this project (Aim 1.1),
- if the eligibility screener or medical records indicate severe medical conditions likely precluding participation (e.g. stroke in the last 6 months, hospitalized with congestive heart failure or a heart attack in the last 6 months, cancer other than skin cancer and receiving active treatment), or
- if the eligibility screener or medical records reveal (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 (completely interferes).
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 (completely interferes).
Change from Baseline Patient Health Questionnaire (PHQ)-8 at 3 months
Time frame: 3 months
The Patient Health Questionnaire (PHQ)-8 is a widely-used, validated 8-item measure of depression severity that uses a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day).
Change from Baseline Patient Health Questionnaire (PHQ)-8 at 6 months
Time frame: 6 months
The Patient Health Questionnaire (PHQ)-8 is a widely-used, validated 8-item measure of depression severity that uses a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day).
10 secondary outcomes
Change from Baseline Generalized Anxiety Disorder (GAD)-7 at 3 months
Time frame: 3 months
Change from Baseline Generalized Anxiety Disorder (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 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 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 Decisional Conflict Scale (DCS) at 3 months
Time frame: 3 months
Change from Baseline Decisional Conflict Scale (DCS) at 6 months
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- 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.
Adam T Hirsh, 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 Musculoskeletal Pain, 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: looking for participants now, as of the sponsor's last update on 9 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Specialist (317-274-9402, equipd@regenstrief.org), or a site near the patient. 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 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2026; AzTrials last refreshed its copy on 29 Oct 2026.