Study Stopped
Study was never initiated due to COVID-19. No study participants were enrolled.
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
2 other identifiers
interventional
N/A
1 country
4
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2023
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2020
CompletedFirst Posted
Study publicly available on registry
March 2, 2020
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedMarch 24, 2023
March 1, 2023
10 months
February 27, 2020
March 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (7)
Interoceptive Awareness, as measured by the Multidimensional Assessment of Interoceptive Awareness (MAIA)
Baseline, 6, 9, and 12 weeks
Affect, as measured by the Positive and Negative Affect Schedule (PANAS).
Baseline, 6, 9, and 12 weeks
Mood, as measured by the Mood Likert Scale
Daily for 12 weeks
Pain, as measured by the Pain Likert Scale
Daily for 12 weeks
Stress, as measured by the Stress Likert Scale
Daily for 12 weeks
- +2 more secondary outcomes
Study Arms (2)
Relief-Hybrid
EXPERIMENTALRelief-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.
Referral to Mental Health/Usual Care
NO INTERVENTIONContinuation 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.
Interventions
A 9-week behavioral intervention for primary care patients designed to reduce depression and pain-related disability.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Weill Cornell Internal Medical Associates (WCIMA)
New York, New York, 10021, United States
Iris Cantor Men's and Women's Health Centers
New York, New York, 10065, United States
Irving Sherwood Wright Center
New York, New York, 10075, United States
Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine
White Plains, New York, 10605, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dimitris Kiosses, PhD
Weill Medical College of Cornell University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Research assistants will be blinded as to who is receiving Relief-Hybrid and who is receiving Usual Care.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2020
First Posted
March 2, 2020
Study Start
February 1, 2023
Primary Completion
December 1, 2023
Study Completion
December 1, 2024
Last Updated
March 24, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data will be available as per NIH's data sharing policy.
- Access Criteria
- Access criteria is determined by NIH and can be requested by applying online.
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.