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

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03265210
Collaborator
National Institute of Mental Health (NIMH) (NIH)
60
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2
58.9
20
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Study Details

Study Description

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
  • Behavioral: RELIEF
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Feb 1, 2018
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in clinically significant depressive symptoms, as measured by the Montgomery Asberg Depression Rating Scale (MADRS) [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) [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) [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) [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 [Daily for 12 weeks]

    Activities monitoring through a phone application; measuring distance covered daily by the participant during the week.

  3. Activities monitoring [Daily for 12 weeks]

    Activities monitoring through a phone application; measuring number of places visited daily during the week.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Weill Cornell Internal Medicine Associates (WCIMA) New York New York United States 10021
2 Iris Cantor Men's & Women's Health Centers New York New York United States 10065
3 Irving Sherwood Wright Center New York New York United States 10075

Sponsors and Collaborators

  • Weill Medical College of Cornell University
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Dimitris Kiosses, PhD, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT03265210
Other Study ID Numbers:
  • 1704018104
  • 5P50MH113838
First Posted:
Aug 29, 2017
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021