Pain, ChronicNCT03487822
A Personalized Self-Management Program for Older Adults With Chronic Pain and Negative Emotions
A study testing Path Pain in people with Pain, Chronic and Negative Emotions, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This study examines the effects of PATH-Pain on emotion regulation to improve self-management of pain and pain-related disability in older adults with chronic pain, negative emotions, and cognitive impairment. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Pain, Chronic, Negative Emotions
- What is being tested?
- Path Pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2017to 26 Jul 2019
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient Participants:
- 60 and older
- chronic pain (pain on most days in past 2 months)
- negative emotions
- MoCA score 16 or higher
- Provider Participants:
- providers 18 or over that took care of patient participant
Who cannot join
- MoCA score <16
- cancer related pain
- can not provide capacity to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Center on Aging (formerly Wright Center on Aging)
New York, New York, 10065
About this study
This study examines the effects of PATH-Pain on emotion regulation to improve self-management of pain and pain-related disability in older adults with chronic pain, negative emotions, and cognitive impairment. Half the participants will receive the intervention, and half the participants will receive usual care with education. Intervention subjects are hypothesized to have significantly less pain-related disability versus usual care subjects after 24 weeks.
Read the detailed description
This study examines the effects of PATH-Pain on emotion regulation to improve self-management of pain and pain-related disability in older adults with chronic pain, negative emotions, and cognitive impairment. The investigators propose that emotion regulation is the mechanism of change through which PATH-Pain improves pain and pain-related disability (outcomes). This pilot study will provide initial evidence of the: a) feasibility and acceptability of PATH-Pain; b) effects of PATH-Pain on emotion regulation (mechanism of change) and outcomes (pain and pain-related disability); and c) mediating effect of emotion regulation (mechanism of change) on outcomes (pain and pain-related disability). The investigators will randomize 120 older adults (60 years or older) with chronic non-cancer related pain and negative emotions to PATH-Pain vs. Usual Care with Education (UCE). PATH-Pain will be administered by licensed mental health clinicians. Research assessments will be conducted at the Wright Center at study entry (baseline), and at 5, 10 (end of treatment), and 24 weeks.
Additionally, 20 providers of patients will be interviewed for feedback regarding the intervention.
Edits were made in November 2024 to better align with the study protocol regarding timing and measures.
- Conditions
- Pain, Chronic, Negative Emotions
- Being tested
- Path Pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Path PainBehavioural
The intervention examines the effects of PATH-Pain on emotion regulation to improve self-management of pain and pain-related disability in older adults with chronic pain, negative emotions, and cognitive impairment. This intervention consists of 8 weekly therapy sessions by a licensed clinician trained in Path Pain, 4 monthly boosters upon completion of therapy, and optional monthly group educational sessions.
| Study group | Role | What they receive |
|---|---|---|
| Path Pain | Experimental | Path Pain participants will be receiving 8 weekly therapy session by license clinicians trained in the Path Pain intervention. Participants will also receive 4, 15-minute phone booster sessions, on a monthly basis after their final therapy session. Participants will also be invited to monthly group educational sessions. Both intervention and usual care participants will be receiving a pain educational booklet. Receives: Behavioral: Path Pain |
| Usual Care with Education | No intervention | Usual Care with Education (UCE) will receive a pain educational booklet. Following completion of 24 weeks in the study, participants will also be invited to attend the monthly group educational sessions. |
| Provider Feedback | No intervention | Providers of patients in the study will take part in a short interview on their impressions of the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Current Pain Intensity on an 11 point scale
Pain intensity is an 11 item scale with a range of 0-11 with a higher score indicating higher pain.
Measured: Baseline, 10 weeks
Change in Pain-related disability (RMDQ)
Pain-related disability as measured by the Roland-Morris Disability Questionnaire (RMDQ). This measure has a range of 0-24, with a higher score indicating higher disability.
Measured: Baseline, 10 weeks
Secondary outcomes (3)
Change in Emotion Regulation Mediation (ERQ)
The Emotion Regulation Questionnaire (ERQ) has a range of 7-70 with a higher score indicating higher emotion regulation strategy.
Measured: Baseline, 10 and 24 weeks
Client Satisfaction Questionnaire (CSQ)
Investigators will use 3 of the 8 questions in the Client Satisfaction Questionnaire (CSQ) which has a range of 3-12; a higher score indicating higher satifaction
Measured: 24 weeks
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
The Montgomery-Asberg Depression Rating Scale (MADRS) has a range of 0-60 with a higher score indicating higher depression
Measured: Baseline, 10 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start8 Aug 2017
- Primary completion26 Jul 2019
- Study completion26 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Cary Reid, MD, PhD, Principal investigator, Weill Medical College of Cornell UniversityDimitris Kiosses, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487822
- Sponsor's protocol ID
- 1509016564
- Other IDs
- 28540451
- Status last verified
- Dec 2024
- First submitted
- 19 Mar 2018
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Personalized Self-Management Program for Older Adults With Chronic Pain and Negative Emotions
- ClinicalTrials.gov ID
- NCT03487822
- Acronym / sponsor ID
- 1509016564
- Conditions
- Pain, Chronic, Negative Emotions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 26 Jul 2019 (actual)
- Study completion
- 26 Jul 2019 (actual)
- First posted
- 4 Apr 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.
This study examines the effects of PATH-Pain on emotion regulation to improve self-management of pain and pain-related disability in older adults with chronic pain, negative emotions, and cognitive impairment. Half the participants will receive the intervention, and half the participants will receive usual care with education. Intervention subjects are hypothesized to have significantly less pain-related disability versus usual care subjects after 24 weeks.
Detailed description
This study examines the effects of PATH-Pain on emotion regulation to improve self-management of pain and pain-related disability in older adults with chronic pain, negative emotions, and cognitive impairment. The investigators propose that emotion regulation is the mechanism of change through which PATH-Pain improves pain and pain-related disability (outcomes). This pilot study will provide initial evidence of the: a) feasibility and acceptability of PATH-Pain; b) effects of PATH-Pain on emotion regulation (mechanism of change) and outcomes (pain and pain-related disability); and c) mediating effect of emotion regulation (mechanism of change) on outcomes (pain and pain-related disability). The investigators will randomize 120 older adults (60 years or older) with chronic non-cancer related pain and negative emotions to PATH-Pain vs. Usual Care with Education (UCE). PATH-Pain will be administered by licensed mental health clinicians. Research assessments will be conducted at the Wright Center at study entry (baseline), and at 5, 10 (end of treatment), and 24 weeks.
Additionally, 20 providers of patients will be interviewed for feedback regarding the intervention.
Edits were made in November 2024 to better align with the study protocol regarding timing and measures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Path Pain | Experimental | Behavioral: Path PainPath Pain participants will be receiving 8 weekly therapy session by license clinicians trained in the Path Pain intervention. Participants will also receive 4, 15-minute phone booster sessions, on a monthly basis after their final therapy session. Participants will also be invited to monthly group educational sessions. Both intervention and usual care participants will be receiving a pain educational booklet. |
| Usual Care with Education | No intervention | –Usual Care with Education (UCE) will receive a pain educational booklet. Following completion of 24 weeks in the study, participants will also be invited to attend the monthly group educational sessions. |
| Provider Feedback | No intervention | –Providers of patients in the study will take part in a short interview on their impressions of the intervention. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 60 and older
- chronic pain (pain on most days in past 2 months)
- negative emotions
- MoCA score 16 or higher
- providers 18 or over that took care of patient participant
Key exclusion criteria (3 listed)
- MoCA score <16
- cancer related pain
- can not provide capacity to consent
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 |
|---|---|---|
| Path PainThe intervention examines the effects of PATH-Pain on emotion regulation to improve self-management of pain and pain-related disability in older adults with chronic pain, negative emotions, and cognitive impairment. This intervention consists of 8 weekly therapy sessions by a licensed clinician trained in Path Pain, 4 monthly boosters upon completion of therapy, and optional monthly group educational sessions. | Behavioural | Path Pain |
Primary outcome
Change in Current Pain Intensity on an 11 point scale
Time frame: Baseline, 10 weeks
Pain intensity is an 11 item scale with a range of 0-11 with a higher score indicating higher pain.
Change in Pain-related disability (RMDQ)
Time frame: Baseline, 10 weeks
Pain-related disability as measured by the Roland-Morris Disability Questionnaire (RMDQ). This measure has a range of 0-24, with a higher score indicating higher disability.
3 secondary outcomes
Change in Emotion Regulation Mediation (ERQ)
Time frame: Baseline, 10 and 24 weeks
Client Satisfaction Questionnaire (CSQ)
Time frame: 24 weeks
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Baseline, 10 and 24 weeks
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 18 Dec 2024.
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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.
Cary Reid, MD, PhD principal investigator
Weill Medical College of Cornell University
Dimitris Kiosses, PhD principal investigator
Weill Medical College of Cornell 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 Path Pain in people with Pain, Chronic and Negative Emotions, run by Weill Medical College of Cornell 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 7 inclusion and 3 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 18 Dec 2024. 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?
Change in Current Pain Intensity on an 11 point scale (time frame: Baseline, 10 weeks). 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?
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 18 Dec 2024.