A Behavioral Intervention for Depression and Chronic Pain in Primary Care

NCT03265210 | Completed Results DMC

• 2 other identifiers: 17040181045P50MH113838
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Pain; Depression

Keywords

Middle-aged and Older Adults; Primary Care

Outcome Measures

Primary Outcomes (3)

• Change in Clinically Significant Depressive 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 indicating no pain and 10 indicating pain as bad as he/she can imagine; scores will be listed under domain 1. In addition, 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; scores will be listed under domain 2.

  Baseline, 6, 9, and 12 weeks

• Client Satisfaction Questionnaire (CSQ)

  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). Domain 1 measures met needs. Scores range from 0-4 and higher scores indicate more needs met. Domain 2 measures satisfaction with services. Scores range from 0-4 and higher scores indicate more satisfaction with services. Domain 3 measures willingness to return. Scores range from 0-4 and higher scores indicate greater willingness to return.

  12 weeks

Secondary Outcomes (3)

• Change in Mood, as Measured by the Daily Photographic Affect Meter (PAM)

  Daily for 12 weeks

• Activities Monitoring

  Daily for 12 weeks

• Activities Monitoring

  Daily for 12 weeks

Study Arms (2)

Relief

EXPERIMENTAL

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

Referral

NO INTERVENTION

Referral for mental health based on clinical indication.

Interventions

RELIEF BEHAVIORAL

A 9-week behavioral intervention for primary care designed to reduce depression and pain-related disability.

Relief

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (3)

Weill Cornell Internal Medicine Associates (WCIMA)

New York, New York, 10021, United States

Location

Iris Cantor Men's & Women's Health Centers

New York, New York, 10065, United States

Location

Irving Sherwood Wright Center

New York, New York, 10075, United States

Location

MeSH Terms

Conditions

Chronic Pain; Depression

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dimitris Kiosses, PhD
• Organization: Weill Cornell Medicine

dkiosses@med.cornell.edu

914-997-4381

Study Officials

• Dimitris Kiosses, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research assistants will be blind to who is receiving Relief and who is not.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 29, 2017
• Study Start: February 1, 2018
• Primary Completion: February 22, 2022
• Study Completion: February 22, 2022
• Last Updated: March 3, 2023
• Results First Posted: February 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.

Locations

US (3)