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

Relief-Hybrid: 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. Older and middle-aged depressed-pain patients: a) are mainly treated in primary care practices; and b) are often prescribed medication, which increases the risk for addiction to opioids and benzodiazepines. Despite the need and desire by the patients and providers for primary care behavioral intervention, behavioral interventions are scarce in primary care.

To address this need, Relief-Hybrid was created. Subjects are randomized to either the Relief-Hybrid intervention or to Referral to Mental Health/Usual Care. Subjects in both arms will complete research assessments at 6, 9, and 12 weeks. Subjects in the Relief-Hybrid arm will receive 5 weekly sessions with the study therapist (licensed social workers, LCSWs) and 4 self-administered, mobile technology-assisted sessions.

Study Overview

• Status: Withdrawn
• Conditions: Depression; Chronic Pain
• Intervention / Treatment: Behavioral: Relief-Hybrid

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dimitris Kiosses, PhD; Phone Number: 914-997-4381; Email: dkiosses@med.cornell.edu
• Study Contact Backup: Name: Laurie Evans, MS; Phone Number: 1012570 914-682-9100; Email: lad9011@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10075
      • Irving Sherwood Wright Center
      • Contact: Joanna Pantelides; Phone Number: 1012903 914-682-9100; Email: jop2285@med.cornell.edu
    • New York, New York, United States, 10021
      • Weill Cornell Internal Medical Associates (WCIMA)
      • Contact: Joanna Pantelides; Phone Number: 1012903 914-682-9100; Email: jop2285@med.cornell.edu
    • New York, New York, United States, 10065
      • Iris Cantor Men's and Women's Health Centers
    • White Plains, New York, United States, 10605
      • Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine
      • Contact: Dimitris Kiosses, PhD; Phone Number: 914-997-4381; Email: dkiosses@med.cornell.edu
      • Contact: Laurie Evans, MS; Phone Number: 1012570 914-682-9100; Email: lad9011@med.cornell.edu

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:

• 50 years or older
• PHQ-9 score greater or equal to 10
• Chronic pain (non-cancer related, most days over the past 3 months)
• Capacity to consent

Exclusion Criteria:

• DSM-5 Axis 1 diagnoses other than depression and anxiety disorders
• Montreal Cognitive Assessment (MoCA) < 24
• Active suicidal ideation (MADRS item #10 greater 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-Hybrid; Relief-Hybrid 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-Hybrid; A 9-week behavioral intervention for primary care patients designed to reduce depression and pain-related disability.
No Intervention: Referral to Mental Health/Usual Care; Continuation of medical attention and treatment provided by physicians and other medical professionals at the primary care practice. Referral for mental health based on clinical indication. Participants receive an educational booklet on pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in depression 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 meaning no pain and 10 meaning pain as bad as he/she can imagine. 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.	Baseline, 6, 9, and 12 weeks
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.	Daily for 12 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interoceptive Awareness, as measured by the Multidimensional Assessment of Interoceptive Awareness (MAIA)	This assessment contains 32 questions measuring 8 areas of manifestations of emotions, including noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. The scores for the questions associated with each of the 8 domains are averaged, with a score of 0 indicating "Never" and a score of 5 indicating "Always"	Baseline, 6, 9, and 12 weeks
Affect, as measured by the Positive and Negative Affect Schedule (PANAS).	This scale consists of a series of 60 words and phrases and participants rate to what extent they have felt that way in the past week. The words are separated into 13 areas: general negative affect, fear, sadness, guilt, hostility, shyness, fatigue, general positive affect, joviality, self-assurance, attentiveness, serenity, and surprise. The scores range from 1 (very slightly/not at all), to 5 (extremely) for each word and each area is summed for the final score.	Baseline, 6, 9, and 12 weeks
Mood, as measured by the Mood Likert Scale	This scale rates current sadness, ranging from 0 (not sad) to 10 (most sad). It also rates interest or pleasure in doing things, ranging from 0 (no interest or pleasure) to 10 (greatest interest or pleasure).	Daily for 12 weeks
Pain, as measured by the Pain Likert Scale	This scale rates current pain, ranging from 0 (no pain) to 10 (worst pain possible).	Daily for 12 weeks
Stress, as measured by the Stress Likert Scale	This scale rates current stress, ranging from 0 (no stress at all) to 10 (great stress).	Daily for 12 weeks
Activities Monitoring	Activities monitoring through a phone application; measuring distance 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.	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 (Anticipated): February 1, 2023
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): March 2, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Chronic Pain; Primary Care; Older Adults; Middle Aged
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pain; Neurologic Manifestations; Depression; Depressive Disorder; Chronic Pain
• Other Study ID Numbers: 19-10020967; 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