Chronic Pain, Depression
Conditions
Keywords
Middle-aged and Older Adults, Primary Care
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.
Interventions
BEHAVIORALRELIEF
A 9-week behavioral intervention for primary care designed to reduce depression and pain-related disability.
Sponsors
National Institute of Mental Health (NIMH)
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Research assistants will be blind to who is receiving Relief and who is not.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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; 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. |
| Client Satisfaction Questionnaire (CSQ) | 12 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). 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. 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. |
| Activities Monitoring | Daily for 12 weeks | Activities monitoring through a phone application; measuring distance in meters covered daily by the participant during the week. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
RELIEF: A 9-week behavioral intervention for primary care designed to reduce depression and pain-related disability. | 50 |
| Referral Referral for mental health based on clinical indication. | 23 |
| Total | 73 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 9 |
Baseline characteristics
| Characteristic | Relief | Total | Referral |
|---|---|---|---|
| Age, Continuous | 67.28 years STANDARD_DEVIATION 10.09 | 67.71 years STANDARD_DEVIATION 10.24 | 68.65 years STANDARD_DEVIATION 10.72 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 10 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 63 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 21 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) White | 32 Participants | 46 Participants | 14 Participants |
| Region of Enrollment United States | 50 participants | 73 participants | 23 participants |
| Sex: Female, Male Female | 39 Participants | 56 Participants | 17 Participants |
| Sex: Female, Male Male | 11 Participants | 17 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 23 |
| other Total, other adverse events | 3 / 50 | 1 / 23 |
| serious Total, serious adverse events | 4 / 50 | 0 / 23 |
Outcome results
Primary
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.
Time frame: Baseline, 6, 9, and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relief | Change in Clinically Significant Depressive Symptoms, as Measured by the Montgomery Asberg Depression Rating Scale (MADRS) | Baseline Totals | 19.37 score on a scale | Standard Deviation 7.27 |
| Relief | Change in Clinically Significant Depressive Symptoms, as Measured by the Montgomery Asberg Depression Rating Scale (MADRS) | Week 9 Totals | 16.44 score on a scale | Standard Deviation 7.66 |
| Relief | Change in Clinically Significant Depressive Symptoms, as Measured by the Montgomery Asberg Depression Rating Scale (MADRS) | Week 6 Totals | 14.88 score on a scale | Standard Deviation 6.73 |
| Relief | Change in Clinically Significant Depressive Symptoms, as Measured by the Montgomery Asberg Depression Rating Scale (MADRS) | Week 12 Totals | 13.30 score on a scale | Standard Deviation 7.39 |
| Referral | Change in Clinically Significant Depressive Symptoms, as Measured by the Montgomery Asberg Depression Rating Scale (MADRS) | Week 12 Totals | 16.67 score on a scale | Standard Deviation 6.97 |
| Referral | Change in Clinically Significant Depressive Symptoms, as Measured by the Montgomery Asberg Depression Rating Scale (MADRS) | Baseline Totals | 20.87 score on a scale | Standard Deviation 5.85 |
| Referral | Change in Clinically Significant Depressive Symptoms, as Measured by the Montgomery Asberg Depression Rating Scale (MADRS) | Week 6 Totals | 18.67 score on a scale | Standard Deviation 6.88 |
| Referral | Change in Clinically Significant Depressive Symptoms, as Measured by the Montgomery Asberg Depression Rating Scale (MADRS) | Week 9 Totals | 18.00 score on a scale | Standard Deviation 7.51 |
Comparison: Baselinep-value: 0.3995% CI: [-4.95, 1.95]t-test, 2 sided
Comparison: 6 weeksp-value: 0.0395% CI: [-7.19, -0.39]t-test, 2 sided
Comparison: 9 weeksp-value: 0.4295% CI: [-5.38, 2.26]t-test, 2 sided
Comparison: 12 weeksp-value: 0.0795% CI: [-7.02, 0.28]t-test, 2 sided
Primary
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.
Time frame: Baseline, 6, 9, and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relief | Change in Pain-related Disability, as Measured by the Roland-Morris Disability Questionnaire (RMDQ) | Domain 1: Baseline | 5.83 score on a scale | Standard Deviation 2.09 |
| Relief | Change in Pain-related Disability, as Measured by the Roland-Morris Disability Questionnaire (RMDQ) | Domain 1: Week 6 | 5.85 score on a scale | Standard Deviation 2.23 |
| Relief | Change in Pain-related Disability, as Measured by the Roland-Morris Disability Questionnaire (RMDQ) | Domain 1: Week 9 | 5.54 score on a scale | Standard Deviation 2.75 |
| Relief | Change in Pain-related Disability, as Measured by the Roland-Morris Disability Questionnaire (RMDQ) | Domain 1: Week 12 | 5.58 score on a scale | Standard Deviation 2.38 |
| Relief | Change in Pain-related Disability, as Measured by the Roland-Morris Disability Questionnaire (RMDQ) | Domain 2: Baseline | 13.17 score on a scale | Standard Deviation 5.25 |
| Relief | Change in Pain-related Disability, as Measured by the Roland-Morris Disability Questionnaire (RMDQ) | Domain 2: Week 6 | 11.70 score on a scale | Standard Deviation 5.24 |
| Relief | Change in Pain-related Disability, as Measured by the Roland-Morris Disability Questionnaire (RMDQ) | Domain 2: Week 9 | 10.26 score on a scale | Standard Deviation 5.59 |
| Relief | Change in Pain-related Disability, as Measured by the Roland-Morris Disability Questionnaire (RMDQ) | Domain 2: Week 12 | 11.05 score on a scale | Standard Deviation 6.2 |
| Referral | Change in Pain-related Disability, as Measured by the Roland-Morris Disability Questionnaire (RMDQ) | Domain 2: Week 12 | 15.40 score on a scale | Standard Deviation 6.2 |
| Referral | Change in Pain-related Disability, as Measured by the Roland-Morris Disability Questionnaire (RMDQ) | Domain 1: Baseline | 6.57 score on a scale | Standard Deviation 2.21 |
| Referral | Change in Pain-related Disability, as Measured by the Roland-Morris Disability Questionnaire (RMDQ) | Domain 2: Baseline | 16.36 score on a scale | Standard Deviation 5.72 |
| Referral | Change in Pain-related Disability, as Measured by the Roland-Morris Disability Questionnaire (RMDQ) | Domain 1: Week 6 | 6.47 score on a scale | Standard Deviation 1.81 |
| Referral | Change in Pain-related Disability, as Measured by the Roland-Morris Disability Questionnaire (RMDQ) | Domain 2: Week 9 | 16.21 score on a scale | Standard Deviation 6.15 |
| Referral | Change in Pain-related Disability, as Measured by the Roland-Morris Disability Questionnaire (RMDQ) | Domain 1: Week 9 | 6.60 score on a scale | Standard Deviation 1.59 |
| Referral | Change in Pain-related Disability, as Measured by the Roland-Morris Disability Questionnaire (RMDQ) | Domain 2: Week 6 | 16.00 score on a scale | Standard Deviation 6.02 |
| Referral | Change in Pain-related Disability, as Measured by the Roland-Morris Disability Questionnaire (RMDQ) | Domain 1: Week 12 | 6.67 score on a scale | Standard Deviation 1.72 |
Comparison: Domain 1, Baselinep-value: 0.1795% CI: [-1.81, 0.33]t-test, 2 sided
Comparison: Domain 1, 6 weeksp-value: 0.2595% CI: [-1.68, 0.44]t-test, 2 sided
Comparison: Domain 1, 9 weeksp-value: 0.0995% CI: [-2.29, 0.17]t-test, 2 sided
Comparison: Domain 1, 12 weeksp-value: 0.0595% CI: [-2.19, 0.01]t-test, 2 sided
Comparison: Domain 2, Baselinep-value: 0.0295% CI: [-5.9, -0.48]t-test, 2 sided
Comparison: Domain 2, 6 weeksp-value: 0.00395% CI: [-7.06, -1.54]t-test, 2 sided
Comparison: Domain 2, 9 weeksp-value: 0.000195% CI: [-8.85, -3.05]t-test, 2 sided
Comparison: Domain 2, 12 weeksp-value: 0.00795% CI: [-7.46, -1.24]t-test, 2 sided
Primary
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.
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relief | Client Satisfaction Questionnaire (CSQ) | Domain 1 | 3.40 score on a scale | Standard Deviation 0.81 |
| Relief | Client Satisfaction Questionnaire (CSQ) | Domain 2 | 3.72 score on a scale | Standard Deviation 0.51 |
| Relief | Client Satisfaction Questionnaire (CSQ) | Domain 3 | 3.67 score on a scale | Standard Deviation 0.68 |
| Referral | Client Satisfaction Questionnaire (CSQ) | Domain 1 | 2.29 score on a scale | Standard Deviation 1.7 |
| Referral | Client Satisfaction Questionnaire (CSQ) | Domain 2 | 3.20 score on a scale | Standard Deviation 0.79 |
| Referral | Client Satisfaction Questionnaire (CSQ) | Domain 3 | 2.71 score on a scale | Standard Deviation 1.89 |
Comparison: Domain 1p-value: 0.000395% CI: [0.53, 1.69]t-test, 2 sided
Comparison: Domain 2p-value: 0.00195% CI: [0.21, 0.83]t-test, 2 sided
Comparison: Domain 3p-value: 0.00295% CI: [0.36, 1.56]t-test, 2 sided
Secondary
Activities Monitoring
Activities monitoring through a phone application; measuring distance in meters covered daily by the participant during the week.
Time frame: Daily for 12 weeks
Population: Data was extracted from wearable devices worn by study participants. Once data was retrieved, some passively collected data was filtered and patients with invalid data points were removed as per study biostatistician.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Relief | Activities Monitoring | 20085.61 meters | Standard Deviation 174446.4 |
| Referral | Activities Monitoring | 1654.16 meters | Standard Deviation 4581.61 |
Secondary
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).
Time frame: Daily for 12 weeks
Population: Data was extracted from wearable devices worn by study participants. Once data was retrieved, some passively collected data was filtered and patients with invalid data points were removed as per study biostatistician.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Relief | Activities Monitoring | 75947.60 seconds | Standard Deviation 23672.34 |
| Referral | Activities Monitoring | 69557.39 seconds | Standard Deviation 29401.19 |
Secondary
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.
Time frame: Daily for 12 weeks
Population: Data was extracted from wearable devices worn by study participants. Once data was retrieved, some passively collected data was filtered and patients with invalid data points were removed as per study biostatistician.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relief | Change in Mood, as Measured by the Daily Photographic Affect Meter (PAM) | Domain 1 | 2.83 score on a scale | Standard Deviation 1.02 |
| Relief | Change in Mood, as Measured by the Daily Photographic Affect Meter (PAM) | Domain 2 | 2.58 score on a scale | Standard Deviation 0.96 |
| Referral | Change in Mood, as Measured by the Daily Photographic Affect Meter (PAM) | Domain 1 | 2.48 score on a scale | Standard Deviation 1.01 |
| Referral | Change in Mood, as Measured by the Daily Photographic Affect Meter (PAM) | Domain 2 | 2.94 score on a scale | Standard Deviation 0.84 |