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

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.

Research assistants will be blinded as to who is receiving Relief-Hybrid and who is receiving Usual Care.

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.

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.

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

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.

The RMDQ includes a scale assessing how much pain the participant has experienced in the past week, with 0 meaning no pain and 10 meaning 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.

The PAM is used for assessing mood and emotional state. Participants can either score a "positive" or "negative" affect value.

Interoceptive Awareness, as measured by the Multidimensional Assessment of Interoceptive Awareness (MAIA)

This assessment contains 32 questions measuring 8 areas of manifestations of emotions, including noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. The scores for the questions associated with each of the 8 domains are averaged, with a score of 0 indicating "Never" and a score of 5 indicating "Always"

This scale consists of a series of 60 words and phrases and participants rate to what extent they have felt that way in the past week. The words are separated into 13 areas: general negative affect, fear, sadness, guilt, hostility, shyness, fatigue, general positive affect, joviality, self-assurance, attentiveness, serenity, and surprise. The scores range from 1 (very slightly/not at all), to 5 (extremely) for each word and each area is summed for the final score.

This scale rates current sadness, ranging from 0 (not sad) to 10 (most sad). It also rates interest or pleasure in doing things, ranging from 0 (no interest or pleasure) to 10 (greatest interest or pleasure).

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

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

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

De-identified data from this study is submitted to the National Database for Clinical Trials related to Mental Illness (NDCT). The NDCT is run by NIH and allows researchers studying mental health to collect and share information with each other. Researchers must apply to NIH in order to be allowed access to the data for 1 year's time; after which they must re-apply.