Chronic PainReliefNCT03265210

A Behavioral Intervention for Depression and Chronic Pain in Primary Care

A study testing RELIEF in people with Chronic Pain and Depression, run by Weill Medical College of Cornell University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 50 years and older
Conditions the study is for: Chronic Pain, Depression
What is being tested?: RELIEF
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 73 participants
Where: 3 sitesUnited States
Study dates: 1 Feb 2018to 22 Feb 2022
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 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 50 years
PHQ-9 greater than or equal to 10
Non-cancer related chronic pain, defined as pain during most days over the past 3 months by patient report
Capacity to consent

Who cannot join

DSM-5 Axis 1 other than depression and anxiety disorders
Montreal Cognitive Assessment (MoCA) < 24
Active suicidal ideation, i.e. MADRS Suicide Item greater than or equal to 4
Severe or life-threatening medical illness.
Patients on psychotropics, opioids or benzodiazepines will be included if they do not meet DSM-5 criteria for opioid, anxiolytics or other substance abuse disorders

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Weill Cornell Internal Medicine Associates (WCIMA)
New York, New York, 10021
Iris Cantor Men's & Women's Health Centers
New York, New York, 10065
Irving Sherwood Wright Center
New York, New York, 10075

Other trials in United States

About this study

Official title: "Relief": A Behavioral Intervention for Depression and Chronic Pain in Primary Care

Chronic pain and depression frequently co-exist in late and mid-life and contribute to increased disability, high health care costs, psychiatric comorbidity, and suicide. The investigators will recruit 60 adults from Weill Cornell Medical Associates primary care practices; participants will be randomized to either Relief (a 9 session behavioral intervention) or usual care/referral for mental health care. Research assessments are conducted with both groups at study entry (Baseline), 6, 9, and 12 weeks.

Conditions: Chronic Pain, Depression
Being tested: RELIEF
Keywords: Middle-aged and Older Adults, Primary Care
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.

RELIEFBehavioural
A 9-week behavioral intervention for primary care designed to reduce depression and pain-related disability.

Study groups in NCT03265210
Study group	Role	What they receive
Relief	Experimental	Relief relies on a neurobiological model to simplify its behavioral targets and uses mobile technology to augment its interventions. Relief was co-developed with our primary care partners with the goal to be usable by non-physician clinicians of primary care offices eligible to provide billable services. Receives: Behavioral: RELIEF
Referral	No intervention	Referral for mental health based on clinical indication.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Clinically Significant Depressive Symptoms, as Measured by the Montgomery Asberg Depression Rating Scale (MADRS)
The MADRS is a 10 item questionnaire assessing severity of depression by scoring participants on mood, anxiety, sleep, concentration, appetite, and suicidal thoughts. The lowest score is 0, no depression symptoms, and the highest possible score is 60, severe depression symptoms.
Measured: Baseline, 6, 9, and 12 weeks
Change in Pain-related Disability, as Measured by the Roland-Morris Disability Questionnaire (RMDQ)
The RMDQ includes a scale assessing how much pain the participant has experienced in the past week, with 0 indicating no pain and 10 indicating pain as bad as he/she can imagine; scores will be listed under domain 1. In addition, the RMDQ also includes a series of questions related to pain disability, with 0 indicating no pain-related disability, and 24 indicating severe pain-related disability; scores will be listed under domain 2.
Measured: Baseline, 6, 9, and 12 weeks
Client Satisfaction Questionnaire (CSQ)
A questionnaire that evaluates participants' satisfaction with treatment; ranging from 1 (needs have not been met/dissatisfied) to 4 (almost all needs have been met/very satisfied).
Domain 1 measures met needs. Scores range from 0-4 and higher scores indicate more needs met. Domain 2 measures satisfaction with services. Scores range from 0-4 and higher scores indicate more satisfaction with services. Domain 3 measures willingness to return. Scores range from 0-4 and higher scores indicate greater willingness to return.
Measured: 12 weeks

Secondary outcomes (3)

Change in Mood, as Measured by the Daily Photographic Affect Meter (PAM)
The PAM is used for assessing mood and emotional state. Participants can either score a "positive" or "negative" affect value. PAM uses photos that user selects and map it to arousal (y-axis) and valence(x-axis). Domain 1 is derived from PAM using y-axis (column score): (low activation to high activation): takes on discrete values ranging from 1 - 5. Domain 2 is derived from PAM using x-axis (row score): (unpleasurable to pleasurable or negative to positive): takes on discrete values ranging from 1 - 4.
Measured: Daily for 12 weeks
Activities Monitoring
Activities monitoring through a phone application; measuring distance in meters covered daily by the participant during the week.
Measured: Daily for 12 weeks
Activities Monitoring
Activities monitoring through a phone application; measuring number of places visited daily during the week. Data is based on the total uptime of the location stream (unit is continuous seconds).
Measured: Daily for 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201822 Feb 2022

First posted29 Aug 2017
Study start1 Feb 2018
Primary completion22 Feb 2022
Study completion22 Feb 2022

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.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 73 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03265210
Sponsor's protocol ID: 1704018104
Other IDs: 5P50MH113838
Acronym: Relief
Status last verified: Mar 2023
First submitted: 10 Aug 2017
Last updated: 3 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified data from this study is submitted to the National Database for Clinical Trials related to Mental Illness (NDCT). The NDCT is run by NIH and allows researchers studying mental health to collect and share information with each other. Researchers must apply to NIH in order to be allowed access to the data for 1 year's time; after which they must re-apply.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Recruiting
Dietary Intervention for Migraine Relief
Migraine
Active, not recruiting
Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty

All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: "Relief": A Behavioral Intervention for Depression and Chronic Pain in Primary Care
ClinicalTrials.gov ID: NCT03265210
Acronym / sponsor ID: Relief / 1704018104
Conditions: Chronic Pain, Depression
Keywords: Middle-aged and Older Adults, Primary Care
Study type: Interventional
Recruitment status: Completed
Enrolment: 73 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 1 Feb 2018 (actual)
Primary completion: 22 Feb 2022 (actual)
Study completion: 22 Feb 2022 (actual)
First posted: 29 Aug 2017 (actual)
Results: Posted 24 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Relief	Experimental	Behavioral: RELIEFRelief relies on a neurobiological model to simplify its behavioral targets and uses mobile technology to augment its interventions. Relief was co-developed with our primary care partners with the goal to be usable by non-physician clinicians of primary care offices eligible to provide billable services.
Referral	No intervention	–Referral for mental health based on clinical indication.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age 50 years
PHQ-9 greater than or equal to 10
Non-cancer related chronic pain, defined as pain during most days over the past 3 months by patient report
Capacity to consent

Key exclusion criteria (5 listed)

DSM-5 Axis 1 other than depression and anxiety disorders
Montreal Cognitive Assessment (MoCA) < 24
Active suicidal ideation, i.e. MADRS Suicide Item greater than or equal to 4
Severe or life-threatening medical illness.
Patients on psychotropics, opioids or benzodiazepines will be included if they do not meet DSM-5 criteria for opioid, anxiolytics or other substance abuse disorders

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
RELIEFA 9-week behavioral intervention for primary care designed to reduce depression and pain-related disability.	Behavioural	Relief

Primary outcome

Change in Clinically Significant Depressive Symptoms, as Measured by the Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: Baseline, 6, 9, and 12 weeks
The MADRS is a 10 item questionnaire assessing severity of depression by scoring participants on mood, anxiety, sleep, concentration, appetite, and suicidal thoughts. The lowest score is 0, no depression symptoms, and the highest possible score is 60, severe depression symptoms.
Change in Pain-related Disability, as Measured by the Roland-Morris Disability Questionnaire (RMDQ)
Time frame: Baseline, 6, 9, and 12 weeks
The RMDQ includes a scale assessing how much pain the participant has experienced in the past week, with 0 indicating no pain and 10 indicating pain as bad as he/she can imagine; scores will be listed under domain 1. In addition, the RMDQ also includes a series of questions related to pain disability, with 0 indicating no pain-related disability, and 24 indicating severe pain-related disability; scores will be listed under domain 2.
Client Satisfaction Questionnaire (CSQ)
Time frame: 12 weeks
A questionnaire that evaluates participants' satisfaction with treatment; ranging from 1 (needs have not been met/dissatisfied) to 4 (almost all needs have been met/very satisfied). Domain 1 measures met needs. Scores range from 0-4 and higher scores indicate more needs met. Domain 2 measures satisfaction with services. Scores range from 0-4 and higher scores indicate more satisfaction with services. Domain 3 measures willingness to return. Scores range from 0-4 and higher scores indicate greater willingness to return.

3 secondary outcomes

Change in Mood, as Measured by the Daily Photographic Affect Meter (PAM)
Time frame: Daily for 12 weeks
Activities Monitoring
Time frame: Daily for 12 weeks
Activities Monitoring
Time frame: Daily for 12 weeks

Results and safety

Results posted to the registry on 24 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Relief	50	38
Referral	23	14

Primary outcome: Change in Clinically Significant Depressive Symptoms, as Measured by the Montgomery Asberg Depression Rating Scale (MADRS)

Time frame: Baseline, 6, 9, and 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Relief n = 50	Referral n = 23
Baseline Totals	19.37 (7.27)	20.87 (5.85)
Week 6 Totals	14.88 (6.73)	18.67 (6.88)
Week 9 Totals	16.44 (7.66)	18.00 (7.51)
Week 12 Totals	13.30 (7.39)	16.67 (6.97)

Relief vs Referral: Mean Difference (Final Values): -1.5 (95% CI -4.95 to 1.95), p = 0.39, t-test, 2 sided
Relief vs Referral: Mean Difference (Final Values): -3.79 (95% CI -7.19 to -0.39), p = 0.03, t-test, 2 sided
Relief vs Referral: Mean Difference (Final Values): -1.56 (95% CI -5.38 to 2.26), p = 0.42, t-test, 2 sided

Primary outcome: Change in Pain-related Disability, as Measured by the Roland-Morris Disability Questionnaire (RMDQ)

Time frame: Baseline, 6, 9, and 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Relief n = 50	Referral n = 23
Domain 1: Baseline	5.83 (2.09)	6.57 (2.21)
Domain 1: Week 6	5.85 (2.23)	6.47 (1.81)
Domain 1: Week 9	5.54 (2.75)	6.60 (1.59)
Domain 1: Week 12	5.58 (2.38)	6.67 (1.72)
Domain 2: Baseline	13.17 (5.25)	16.36 (5.72)
Domain 2: Week 6	11.70 (5.24)	16.00 (6.02)
Domain 2: Week 9	10.26 (5.59)	16.21 (6.15)
Domain 2: Week 12	11.05 (6.20)	15.40 (6.20)

Relief vs Referral: Mean Difference (Final Values): -0.74 (95% CI -1.81 to 0.33), p = 0.17, t-test, 2 sided
Relief vs Referral: Mean Difference (Final Values): -0.62 (95% CI -1.68 to 0.44), p = 0.25, t-test, 2 sided
Relief vs Referral: Mean Difference (Final Values): -1.06 (95% CI -2.29 to 0.17), p = 0.09, t-test, 2 sided

Primary outcome: Client Satisfaction Questionnaire (CSQ)

Time frame: 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Relief n = 50	Referral n = 23
Domain 1	3.40 (0.81)	2.29 (1.70)
Domain 2	3.72 (0.51)	3.20 (0.79)
Domain 3	3.67 (0.68)	2.71 (1.89)

Relief vs Referral: Mean Difference (Final Values): 1.11 (95% CI 0.53 to 1.69), p = 0.0003, t-test, 2 sided
Relief vs Referral: Mean Difference (Final Values): 0.52 (95% CI 0.21 to 0.83), p = 0.001, t-test, 2 sided
Relief vs Referral: Mean Difference (Final Values): 0.96 (95% CI 0.36 to 1.56), p = 0.002, t-test, 2 sided

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks (total duration of study). Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Relief	4 of 50 (8%)	3 of 50 (6%)	0 of 50
Referral	0 of 23 (0%)	1 of 23 (4.3%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. De-identified data from this study is submitted to the National Database for Clinical Trials related to Mental Illness (NDCT). The NDCT is run by NIH and allows researchers studying mental health to collect and share information with each other. Researchers must apply to NIH in order to be allowed access to the data for 1 year's time; after which they must re-apply.

Related trials for Chronic Pain

Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Recruiting
Dietary Intervention for Migraine Relief
Migraine
Active, not recruiting
Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty

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.

Dimitris Kiosses, PhD principal investigator

Weill Medical College of Cornell University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing RELIEF in people with Chronic Pain and Depression, run by Weill Medical College of Cornell University at 3 sites 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 4 inclusion and 5 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 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 24 Feb 2023). 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 in Clinically Significant Depressive Symptoms, as Measured by the Montgomery Asberg Depression Rating Scale (MADRS) (time frame: Baseline, 6, 9, and 12 weeks). The study lists 3 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 NCT03265210.

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 3 Mar 2023.