N/A
N=73
A Behavioral Intervention for Depression and Chronic Pain in Primary Care
Chronic Pain · Depression
Bottom Line
View on ClinicalTrials.gov: NCT03265210 ↗Enrolled (actual)
73
Serious AEs
5.5%
Results posted
Feb 2023
Primary outcome: Primary: Change in Clinically Significant Depressive Symptoms, as Measured by the Montgomery Asberg Depression Rating Scale (MADRS) — 19.37; 20.87; 14.88; 18.67 score on a scale — p=0.39
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RELIEF (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Clinically Significant Depressive Symptoms, as Measured by the Montgomery Asberg Depression Rating Scale (MADRS) |
19.37; 20.87; 14.88; 18.67; 16.44; 18.00 | 0.39 |
| PRIMARY Change in Pain-related Disability, as Measured by the Roland-Morris Disability Questionnaire (RMDQ) |
5.83; 6.57; 5.85; 6.47; 5.54; 6.60 | 0.17 |
| PRIMARY Client Satisfaction Questionnaire (CSQ) |
3.40; 2.29; 3.72; 3.20; 3.67; 2.71 | 0.0003 sig |
| SECONDARY Change in Mood, as Measured by the Daily Photographic Affect Meter (PAM) |
2.83; 2.48; 2.58; 2.94 | — |
| SECONDARY Activities Monitoring |
75947.60; 69557.39 | — |
| SECONDARY Activities Monitoring |
75947.60; 69557.39 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03265210). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.