Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03265210
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : May 6, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Depression Behavioral: RELIEF Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Research assistants will be blind to who is receiving Relief and who is not.
Primary Purpose: Treatment
Official Title: "Relief": A Behavioral Intervention for Depression and Chronic Pain in Primary Care
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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.



Primary Outcome Measures :
  1. 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.

  2. 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.

    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.


  3. Client Satisfaction Questionnaire (CSQ) [ Time Frame: 9 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).


Secondary Outcome Measures :
  1. Change in Mood, as measured by the Daily Photographic Affect Meter (PAM) [ Time Frame: Daily for 12 weeks ]
    The PAM is used for assessing mood and emotional state. Participants can either score a "positive" or "negative" affect value.

  2. Activities monitoring [ Time Frame: Daily for 12 weeks ]
    Activities monitoring through a phone application; measuring distance covered daily by the participant during the week.

  3. Activities monitoring [ Time Frame: Daily for 12 weeks ]
    Activities monitoring through a phone application; measuring number of places visited daily during the week.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265210


Contacts
Layout table for location contacts
Contact: Dimitris Kiosses, PhD 914-997-4381 dkiosses@med.cornell.edu
Contact: Laurie Evans, MS 914-682-9100 ext 1012570 lad9011@med.cornell.edu

Locations
Layout table for location information
United States, New York
Weill Cornell Internal Medicine Associates (WCIMA) Recruiting
New York, New York, United States, 10021
Contact: Joanna Pantelides    914-682-9100 ext 1012903    jop2285@med.cornell.edu   
Iris Cantor Men's & Women's Health Centers Recruiting
New York, New York, United States, 10065
Contact: Joanna Pantelides    914-682-9100 ext 1012903    jop2285@med.cornell.edu   
Irving Sherwood Wright Center Recruiting
New York, New York, United States, 10075
Contact: Joanna Pantelides    914-682-9100 ext 1012903    jop2285@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Principal Investigator: Dimitris Kiosses, PhD Weill Medical College of Cornell University
Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03265210    
Other Study ID Numbers: 1704018104
5P50MH113838 ( U.S. NIH Grant/Contract )
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
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.
URL: https://nda.nih.gov/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weill Medical College of Cornell University:
Middle-aged and Older Adults
Primary Care
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pain
Neurologic Manifestations