A Behavioral Intervention for Depression and Chronic Pain in Primary Care

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. The investigators will recruit 60 adults from Weill Cornell Medical Associates primary care practices; participants will be randomized to either Relief (a 9 session behavioral intervention) or usual care/referral for mental health care. Research assessments are conducted with both groups at study entry (Baseline), 6, 9, and 12 weeks.

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

Conditions
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Chronic Pain, Depression

Intervention / Treatment
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* Behavioral: RELIEF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 50 years PHQ-9 greater than or equal to 10 Non-cancer related chronic pain, defined as pain during most days over the past 3 months by patient report Capacity to consent Exclusion Criteria: DSM-5 Axis 1 other than depression and anxiety disorders Montreal Cognitive Assessment (MoCA) < 24 Active suicidal ideation, i.e. MADRS Suicide Item greater than 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<br>Relief 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<br>* A 9-week behavioral intervention for primary care designed to reduce depression and pain-related disability.<br>|
| No Intervention: Referral<br>Referral for mental health based on clinical indication. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinically Significant Depressive 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 indicating no pain and 10 indicating pain as bad as he/she can imagine; scores will be listed under domain 1. In addition, 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; scores will be listed under domain 2. | Baseline, 6, 9, and 12 weeks | 
| Client Satisfaction Questionnaire (CSQ) | A questionnaire that evaluates participants' satisfaction with treatment; ranging from 1 (needs have not been met/dissatisfied) to 4 (almost all needs have been met/very satisfied). Domain 1 measures met needs. Scores range from 0-4 and higher scores indicate more needs met. Domain 2 measures satisfaction with services. Scores range from 0-4 and higher scores indicate more satisfaction with services. Domain 3 measures willingness to return. Scores range from 0-4 and higher scores indicate greater willingness to return. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. PAM uses photos that user selects and map it to arousal (y-axis) and valence(x-axis). Domain 1 is derived from PAM using y-axis (column score): (low activation to high activation): takes on discrete values ranging from 1 - 5. Domain 2 is derived from PAM using x-axis (row score): (unpleasurable to pleasurable or negative to positive): takes on discrete values ranging from 1 - 4. | Daily for 12 weeks | 
| Activities Monitoring | Activities monitoring through a phone application; measuring distance in meters 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. Data is based on the total uptime of the location stream (unit is continuous seconds). | Daily for 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Middle-aged and Older Adults, Primary Care