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

NCT ID: NCT04290845

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2024-12-31

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.

Conditions

Chronic Pain; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Relief-Hybrid

Relief-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.

Group Type: EXPERIMENTAL

Relief-Hybrid

Intervention Type: BEHAVIORAL

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

Referral to Mental Health/Usual Care

Continuation 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Relief-Hybrid

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 50 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dimitris Kiosses, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Internal Medical Associates (WCIMA)

New York, New York, United States

Iris Cantor Men's and Women's Health Centers

New York, New York, United States

Irving Sherwood Wright Center

New York, New York, United States

Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine

White Plains, New York, United States

Countries

United States

Other Identifiers

5P50MH113838

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-10020967

Identifier Type: -

Identifier Source: org_study_id