A Behavioral Intervention for Depression and Chronic Pain in Primary Care (Relief)

"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.

Study Overview

• Status: Completed
• Conditions: Depression; Chronic Pain
• Intervention / Treatment: Behavioral: RELIEF

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Relief; 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.	Behavioral: RELIEF; A 9-week behavioral intervention for primary care designed to reduce depression and pain-related disability.
No Intervention: Referral; Referral for mental health based on clinical indication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Daily for 12 weeks
Activities Monitoring	Activities monitoring through a phone application; measuring distance in meters covered daily by the participant during the week.	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).	Daily for 12 weeks

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Dimitris Kiosses, PhD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): February 22, 2022
• Study Completion (Actual): February 22, 2022

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Primary Care; Middle-aged and Older Adults
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pain; Neurologic Manifestations; Depression; Depressive Disorder; Chronic Pain
• Other Study ID Numbers: 1704018104; 5P50MH113838 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No