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

Weill Cornell Medicine (WCM)

Status: Withdrawn

Conditions: Chronic Pain; Depression

Treatments: Behavioral: Relief-Hybrid

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04290845

5P50MH113838 (U.S. NIH Grant/Contract)

19-10020967

Details and patient eligibility

About

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.

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Relief-Hybrid

Experimental group

Description:

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.

Treatment:

Behavioral: Relief-Hybrid

Referral to Mental Health/Usual Care

No Intervention group

Description:

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.