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

Study Overview
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Brief Summary
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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.

Official Title
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Relief-Hybrid: A Behavioral Intervention for Depression and Chronic Pain in Primary Care

Conditions
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Depression, Chronic Pain

Intervention / Treatment
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* Behavioral: Relief-Hybrid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Relief-Hybrid<br>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. | Behavioral: Relief-Hybrid<br>* A 9-week behavioral intervention for primary care patients designed to reduce depression and pain-related disability.<br>|
| No Intervention: Referral to Mental Health/Usual Care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Daily for 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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). | 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). | 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). | Daily for 12 weeks | 
| Activities Monitoring | Activities monitoring through a phone application; measuring distance covered daily by the participant during the week. | Daily for 12 Weeks | 
| Activities Monitoring | Activities monitoring through a phone application; measuring number of places visited daily during the week. | Daily for 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Chronic Pain, Primary Care, Older Adults, Middle Aged