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

Weill Medical College of Cornell University

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Chronic Pain Depression

Interventions

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (4)

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

Outcomes

Primary Outcomes

Change in depression 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.

Time frame: 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 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.

Time frame: Baseline, 6, 9, and 12 weeks

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

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

Time frame: Daily for 12 Weeks

Secondary Outcomes

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"

Time frame: Baseline, 6, 9, and 12 weeks

Affect, as measured by the Positive and Negative Affect Schedule (PANAS).

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.

Time frame: Baseline, 6, 9, and 12 weeks

Mood, as measured by the Mood Likert Scale

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).

Time frame: Daily for 12 weeks

Pain, as measured by the Pain Likert Scale

This scale rates current pain, ranging from 0 (no pain) to 10 (worst pain possible).

Time frame: Daily for 12 weeks

Stress, as measured by the Stress Likert Scale

This scale rates current stress, ranging from 0 (no stress at all) to 10 (great stress).

Time frame: Daily for 12 weeks

Activities Monitoring

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

Time frame: Daily for 12 Weeks

Activities Monitoring

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

Time frame: Daily for 12 Weeks