Chronic PainNCT03692468
A Brief Intervention for Chronic Pain in Primary Care
A study testing Psychotherapy in people with Chronic Pain, run by Henry Ford Health System at 1 site in United States.
Trial summary
The purpose of this research study is to investigate potential benefits of a behavioral intervention for co-occurring chronic pain and distress that is delivered in a primary care clinic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2018to 18 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Chronic pain condition
- A current patient within the Henry Ford Health System Academic Internal Medicine Clinic in Detroit
- Has been within the Henry Ford Health System for at least 6 months
Who cannot join
- Current behavioral health treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Brief Intervention for Co-occurring Pain and Distress in Primary Care
The purpose of this research study is to investigate potential benefits of a behavioral intervention for co-occurring chronic pain and distress that is delivered in a primary care clinic.
- Conditions
- Chronic Pain
- Being tested
- Psychotherapy
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
Participants will complete 5, 60 minutes sessions. At each session, participants will learn strategies that have been shown to improve pain functioning and/or mood for patients who have chronic pain. The intervention will be delivered in the patient's primary care clinic.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants will engage in a 5 session psychotherapy intervention focused on improving pain and mood. Receives: Behavioral: Psychotherapy |
| Control Group | No intervention | Patients will receive treatment as usual from their care providers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory
The Brief Pain Inventory measures pain severity and pain functioning. Pain severity is comprised of 4 questions on a 0-10 scale for pain at it's worst in the past week, the least in the past week, on average, and then currently. Each item is scored separately and higher scores indicate greater pain severity. There are then 12 daily activities in which the participants rates on a scale of 0-10 regarding how much the pain interferes with the activity (10 being the highest interference). These are all scored separately.
Measured: 5 weeks post-baseline
Hospital Anxiety and Depression Scale
This measure assesses the severity of depression and anxiety. Scores on each of the subscale (e.g., depression and anxiety) range from 0-21 with higher scores indicating greater severity.
Measured: 5 weeks post-baseline
Secondary outcomes (4)
Insomnia Severity Index
This measure assess difficulty with sleep. Total scores range from 0-28, with greater numbers indicating greater sleep difficulty.
Measured: Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups
Pain Catastrophizing Scale
This measure assesses catastrophizing thoughts about pain. Total scores range from 0-52 with higher scores indicating greater catastrophizing. The three subscales are rumination (range= 0-16), magnification (range= 0-12), and helplessness (range= 0-24).
Measured: Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups
Satisfaction with Life Scale
This measure assesses how satisfied a patient is with their life. Total scores range from 7-35 with higher scores indicating greater satisfaction.
Measured: Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups
Health care utilization
The number of primary and specialty care visits, prescriptions written, emergency room visits, and hospital admissions
Measured: Measured 6 months before and 6 months after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start20 Sep 2018
- Primary completion21 Apr 2020
- Study completion18 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Matero, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692468
- Sponsor's protocol ID
- Pain in Primary Care
- Status last verified
- Dec 2022
- First submitted
- 20 Sep 2018
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Miller-Matero LR, Hecht LM, Gavrilova L, Haage B, Autio K, Tobin ET, Ahmedani BK. Utilizing primary care to engage underserved patients in a psychological intervention for chronic pain. Prim Health Care Res Dev. 2024 Oct 25;25:e54. doi: 10.1017/S1463423624000471.
PubMed 39450755Miller-Matero LR, Gavrilova L, Hecht LM, Autio K, Tobin ET, Braciszewski JM, Maye M, Felton JW, Ahmedani BK. A brief psychological intervention for chronic pain in primary care: Examining long-term effects from a pilot randomized clinical trial. Pain Pract. 2022 Jul;22(6):564-570. doi: 10.1111/papr.13134. Epub 2022 Jun 14.
PubMed 35665994Miller-Matero LR, Hecht LM, Miller MK, Autio K, Pester BD, Tobin ET, Patel S, Braciszewski JM, Maye M, Ahmedani BK. A Brief Psychological Intervention for Chronic Pain in Primary Care: A Pilot Randomized Controlled Trial. Pain Med. 2021 Jul 25;22(7):1603-1611. doi: 10.1093/pm/pnaa444.
PubMed 33616190
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Intervention for Co-occurring Pain and Distress in Primary Care
- ClinicalTrials.gov ID
- NCT03692468
- Acronym / sponsor ID
- Pain in Primary Care
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 21 Apr 2020 (actual)
- Study completion
- 18 Nov 2020 (actual)
- First posted
- 2 Oct 2018 (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.
The purpose of this research study is to investigate potential benefits of a behavioral intervention for co-occurring chronic pain and distress that is delivered in a primary care clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: PsychotherapyParticipants will engage in a 5 session psychotherapy intervention focused on improving pain and mood. |
| Control Group | No intervention | –Patients will receive treatment as usual from their care providers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic pain condition
- A current patient within the Henry Ford Health System Academic Internal Medicine Clinic in Detroit
- Has been within the Henry Ford Health System for at least 6 months
Key exclusion criteria (1 listed)
- Current behavioral health treatment
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 |
|---|---|---|
| PsychotherapyParticipants will complete 5, 60 minutes sessions. At each session, participants will learn strategies that have been shown to improve pain functioning and/or mood for patients who have chronic pain. The intervention will be delivered in the patient's primary care clinic. | Behavioural | Intervention Group |
Primary outcome
Brief Pain Inventory
Time frame: 5 weeks post-baseline
The Brief Pain Inventory measures pain severity and pain functioning. Pain severity is comprised of 4 questions on a 0-10 scale for pain at it's worst in the past week, the least in the past week, on average, and then currently. Each item is scored separately and higher scores indicate greater pain severity. There are then 12 daily activities in which the participants rates on a scale of 0-10 regarding how much the pain interferes with the activity (10 being the highest interference). These are all scored separately.
Hospital Anxiety and Depression Scale
Time frame: 5 weeks post-baseline
This measure assesses the severity of depression and anxiety. Scores on each of the subscale (e.g., depression and anxiety) range from 0-21 with higher scores indicating greater severity.
4 secondary outcomes
Insomnia Severity Index
Time frame: Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups
Pain Catastrophizing Scale
Time frame: Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups
Satisfaction with Life Scale
Time frame: Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups
Health care utilization
Time frame: Measured 6 months before and 6 months after study enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Derived from this study: PubMed 39450755Miller-Matero LR, Hecht LM, Gavrilova L, Haage B, Autio K, Tobin ET, Ahmedani BK. Utilizing primary care to engage underserved patients in a psychological intervention for chronic pain. Prim Health Care Res Dev. 2024 Oct 25;25:e54. doi: 10.1017/S1463423624000471.
- Derived from this study: PubMed 35665994Miller-Matero LR, Gavrilova L, Hecht LM, Autio K, Tobin ET, Braciszewski JM, Maye M, Felton JW, Ahmedani BK. A brief psychological intervention for chronic pain in primary care: Examining long-term effects from a pilot randomized clinical trial. Pain Pract. 2022 Jul;22(6):564-570. doi: 10.1111/papr.13134. Epub 2022 Jun 14.
- Derived from this study: PubMed 33616190Miller-Matero LR, Hecht LM, Miller MK, Autio K, Pester BD, Tobin ET, Patel S, Braciszewski JM, Maye M, Ahmedani BK. A Brief Psychological Intervention for Chronic Pain in Primary Care: A Pilot Randomized Controlled Trial. Pain Med. 2021 Jul 25;22(7):1603-1611. doi: 10.1093/pm/pnaa444.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy in people with Chronic Pain, run by Henry Ford Health System 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 3 inclusion and 1 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 7 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Brief Pain Inventory (time frame: 5 weeks post-baseline). 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 NCT03692468, which also lists 3 linked publications.
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 7 Dec 2022.