Back to resultsA Behavioral Intervention for Depression and Chronic Pain in Primary Care (Relief)
Primary Purpose
Chronic Pain, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RELIEF
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Middle-aged and Older Adults, Primary Care
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Weill Cornell Internal Medicine Associates (WCIMA)
- Iris Cantor Men's & Women's Health Centers
- Irving Sherwood Wright Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Relief
Referral
Arm Description
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.
Referral for mental health based on clinical indication.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
Activities Monitoring
Activities monitoring through a phone application; measuring distance in meters covered daily by the participant during the week.
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).
Full Information
NCT ID
NCT03265210
First Posted
August 10, 2017
Last Updated
March 1, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT03265210
Brief Title
A Behavioral Intervention for Depression and Chronic Pain in Primary Care
Acronym
Relief
Official Title
"Relief": A Behavioral Intervention for Depression and Chronic Pain in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
February 22, 2022 (Actual)
Study Completion Date
February 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Depression
Keywords
Middle-aged and Older Adults, Primary Care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Research assistants will be blind to who is receiving Relief and who is not.
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Relief
Arm Type
Experimental
Arm Description
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.
Arm Title
Referral
Arm Type
No Intervention
Arm Description
Referral for mental health based on clinical indication.
Intervention Type
Behavioral
Intervention Name(s)
RELIEF
Intervention Description
A 9-week behavioral intervention for primary care designed to reduce depression and pain-related disability.
Primary Outcome Measure Information:
Title
Change in Clinically Significant Depressive Symptoms, as Measured by the Montgomery Asberg Depression Rating Scale (MADRS)
Description
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.
Time Frame
Baseline, 6, 9, and 12 weeks
Title
Change in Pain-related Disability, as Measured by the Roland-Morris Disability Questionnaire (RMDQ)
Description
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.
Time Frame
Baseline, 6, 9, and 12 weeks
Title
Client Satisfaction Questionnaire (CSQ)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Mood, as Measured by the Daily Photographic Affect Meter (PAM)
Description
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.
Time Frame
Daily for 12 weeks
Title
Activities Monitoring
Description
Activities monitoring through a phone application; measuring distance in meters covered daily by the participant during the week.
Time Frame
Daily for 12 weeks
Title
Activities Monitoring
Description
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).
Time Frame
Daily for 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitris Kiosses, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Internal Medicine Associates (WCIMA)
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Iris Cantor Men's & Women's Health Centers
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Irving Sherwood Wright Center
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data will be available as per NIH's data sharing policy.
IPD Sharing Access Criteria
Access criteria is determined by NIH and can be requested by applying online.
IPD Sharing URL
https://nda.nih.gov/
Learn more about this trial
A Behavioral Intervention for Depression and Chronic Pain in Primary Care
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