Relief: A Behavioral Intervention for Depression and Chronic Pain in Primary Care
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Relief 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
A 9-week behavioral intervention for primary care designed to reduce depression and pain-related disability.
|
No Intervention: Referral Referral for mental health based on clinical indication. |
Outcome Measures
Primary Outcome Measures
- Change in clinically significant depressive symptoms, as measured by the Montgomery Asberg Depression Rating Scale (MADRS) [Baseline, 6, 9, and 12 weeks]
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.
- Change in pain-related disability, as measured by the Roland-Morris Disability Questionnaire (RMDQ) [Baseline, 6, 9, and 12 weeks]
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. 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.
- Client Satisfaction Questionnaire (CSQ) [9 weeks]
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).
Secondary Outcome Measures
- Change in Mood, as measured by the Daily Photographic Affect Meter (PAM) [Daily for 12 weeks]
The PAM is used for assessing mood and emotional state. Participants can either score a "positive" or "negative" affect value.
- Activities monitoring [Daily for 12 weeks]
Activities monitoring through a phone application; measuring distance covered daily by the participant during the week.
- Activities monitoring [Daily for 12 weeks]
Activities monitoring through a phone application; measuring number of places visited daily during the week.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 50 years
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PHQ-9 greater than or equal to 10
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Non-cancer related chronic pain, defined as pain during most days over the past 3 months by patient report
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Capacity to consent
Exclusion Criteria:
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DSM-5 Axis 1 other than depression and anxiety disorders
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Montreal Cognitive Assessment (MoCA) < 24
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Active suicidal ideation, i.e. MADRS Suicide Item greater than or equal to 4
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Severe or life-threatening medical illness.
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Weill Cornell Internal Medicine Associates (WCIMA) | New York | New York | United States | 10021 |
2 | Iris Cantor Men's & Women's Health Centers | New York | New York | United States | 10065 |
3 | Irving Sherwood Wright Center | New York | New York | United States | 10075 |
Sponsors and Collaborators
- Weill Medical College of Cornell University
- National Institute of Mental Health (NIMH)
Investigators
- Principal Investigator: Dimitris Kiosses, PhD, Weill Medical College of Cornell University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1704018104
- 5P50MH113838