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

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ClinicalTrials.gov Identifier: NCT03265210
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : March 8, 2019
Sponsor:
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 two randomly assigned large WCMA primary care practices; one practice will offer Relief (a 9 session behavioral intervention) and the other will offer referral for mental health care.

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

Detailed Description:

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, the investigators worked with primary care practices of the Weill Cornell Medical Associates (WCMA), and developed Relief, a 9-session behavioral intervention, designed to be administered by licensed social workers (LCSWs) and/or nurse practitioners (NP) in primary care practices.

The investigators will recruit 60 adults (50+ years old), from two randomly assigned large WCMA primary care practices that screen all patients for depression with the PHQ-9. One practice will offer Relief (N=40) and one will offer referral (based on clinical indication) for mental health care (N=20), provided at the practice site. Participants will have clinically significant depression (PHQ-9 ≥10) and suffer from pain (during most days for ≥ 3 months). To facilitate future implementation studies, WCMA LCSWs and NPs will administer Relief. Assessments will be conducted at entry, and at 6, 9, & 12 weeks.


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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 : September 1, 2019
Estimated Study Completion Date : September 1, 2019

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. Client Satisfaction Questionnaire (CSQ) [ Time Frame: 9 weeks ]
    A questionnaire that evaluates participants' satisfaction with treatment

  2. Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 12 weeks ]
    An interviewer-administered instrument that assesses depression

  3. Roland-Morris Disability Questionnaire (RMDQ) [ Time Frame: 12 weeks ]
    An instrument that assesses pain-related disability


Secondary Outcome Measures :
  1. Daily Photographic Affect Meter (PAM) [ Time Frame: 12 weeks ]
    A self-report measure of mood

  2. Activities monitoring [ Time Frame: 12 weeks ]
    Activities monitoring through a phone application; measuring distance covered by the participant during the week and number of places visited during the week. Both will be captured through an iPhone application.



Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Age 50 years
  2. PHQ-9 greater than or equal to 10; this cut-off represents depression of moderate severity and has a sensitivity of 88% and a specificity of 88% for major depression. Thus, most participants are expected to have a DSM-5 depression diagnosis. In addition, PHQ-9 scores have a significant positive association with pain-related disability assessed with SF-20
  3. Non-cancer related chronic pain, defined as pain during most days over the past 3 months by patient report
  4. Capacity to consent determined by a clinician of the primary care practice.

Exclusion Criteria:

  1. DSM-5 Axis 1 other than depression and anxiety disorders
  2. Mini Mental State Exam < 24
  3. Active suicidal ideation, i.e. MADRS Suicide Item greater than or equal to 4; 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
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Contact: Dimitris Kiosses, PhD 9149974381 dkiosses@med.cornell.edu
Contact: Laurie Evans, MS 9146829100 ext 2570 lad9011@med.cornell.edu

Locations
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United States, New York
Weill Cornell Internal Medicine Associates Recruiting
New York, New York, United States, 10021
Contact: Joanna Pantelides    914-682-9100 ext 2903    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 2903    jop2285@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Dimitris Kiosses, PhD Weill Cornell Medicine

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03265210     History of Changes
Other Study ID Numbers: 1704018104
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data sharing plan of the NIMH.

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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:
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Depression
Depressive Disorder
Chronic Pain
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pain
Neurologic Manifestations
Signs and Symptoms