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| ID | Type | Description | Link |
|---|---|---|---|
| 5P50MH113838 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relief | Experimental | 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. |
|
| Referral | No Intervention | Referral for mental health based on clinical indication. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RELIEF | Behavioral | A 9-week behavioral intervention for primary care designed to reduce depression and pain-related disability. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dimitris Kiosses, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Internal Medicine Associates (WCIMA) | New York | New York | 10021 | United States | ||
| Iris Cantor Men's & Women's Health Centers |
De-identified data from this study is submitted to the National Database for Clinical Trials related to Mental Illness (NDCT). The NDCT is run by NIH and allows researchers studying mental health to collect and share information with each other. Researchers must apply to NIH in order to be allowed access to the data for 1 year's time; after which they must re-apply.
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Data will be available as per NIH's data sharing policy.
Access criteria is determined by NIH and can be requested by applying online.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Referral | Referral for mental health based on clinical indication. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6, 9, and 12 weeks |
|
12 weeks (total duration of study)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Cardiac disorders | Non-systematic Assessment | Participant admitted to hospital for atrial fibrillation. Participant admitted to hospital for tachycardia following radiation treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Participants experienced rash on wrist underneath study smart watch. No medical attention necessary; went away on its own. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dimitris Kiosses, PhD | Weill Cornell Medicine | 914-997-4381 | dkiosses@med.cornell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 30, 2020 | Jan 18, 2023 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 14, 2016 | Jan 23, 2023 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D003863 | Depression |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Research assistants will be blind to who is receiving Relief and who is not.
| 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 |
| New York |
| New York |
| 10065 |
| United States |
| Irving Sherwood Wright Center | New York | New York | 10075 | United States |
| Physician Decision |
|
| Adverse Event |
|
| BG001 | Referral | Referral for mental health based on clinical indication. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Referral | Referral for mental health based on clinical indication. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6, 9, and 12 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Daily for 12 weeks |
|
|
|
| Secondary | Activities Monitoring | Activities monitoring through a phone application; measuring distance in meters covered daily by the participant during the week. | 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. | Posted | Mean | Standard Deviation | meters | Daily for 12 weeks |
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | seconds | Daily for 12 weeks |
|
|
|
| 0 |
| 50 |
| 4 |
| 50 |
| 3 |
| 50 |
| EG001 | Referral | Referral for mental health based on clinical indication. | 0 | 23 | 0 | 23 | 1 | 23 |
|
| Hospitalization | Psychiatric disorders | Non-systematic Assessment | Participant psychiatrically hospitalized. |
|
| Surgery | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Participant had scheduled surgery to remove tumor on lung. |
|
| Hospitalization | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Participant hospitalized for numbness and dysphagia following treatment for esophageal cancer. |
|
|
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| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| Domain 1: Week 9 |
|
| Domain 1: Week 12 |
|
| Domain 2: Baseline |
|
| Domain 2: Week 6 |
|
| Domain 2: Week 9 |
|
| Domain 2: Week 12 |
|
| t-test, 2 sided |
| 0.25 |
| Mean Difference (Final Values) |
| -0.62 |
| 2-Sided |
| 95 |
| -1.68 |
| 0.44 |
Mean value in Relief Arm minus Mean value in Referral Arm. |
| Superiority |
| Domain 1, 9 weeks | t-test, 2 sided | 0.09 | Mean Difference (Final Values) | -1.06 | 2-Sided | 95 | -2.29 | 0.17 | Mean value in Relief Arm minus Mean value in Referral Arm. | Superiority |
| Domain 1, 12 weeks | t-test, 2 sided | 0.05 | Mean Difference (Final Values) | -1.09 | 2-Sided | 95 | -2.19 | 0.01 | Mean value in Relief Arm minus Mean value in Referral Arm. | Superiority |
| Domain 2, Baseline | t-test, 2 sided | 0.02 | Mean Difference (Final Values) | -3.19 | 2-Sided | 95 | -5.90 | -0.48 | Mean value in Relief Arm minus Mean value in Referral Arm. | Superiority |
| Domain 2, 6 weeks | t-test, 2 sided | 0.003 | Mean Difference (Final Values) | -4.3 | 2-Sided | 95 | -7.06 | -1.54 | Mean value in Relief Arm minus Mean value in Referral Arm. | Superiority |
| Domain 2, 9 weeks | t-test, 2 sided | 0.0001 | Mean Difference (Final Values) | -5.95 | 2-Sided | 95 | -8.85 | -3.05 | Mean value in Relief Arm minus Mean value in Referral Arm. | Superiority |
| Domain 2, 12 weeks | t-test, 2 sided | 0.007 | Mean Difference (Final Values) | -4.35 | 2-Sided | 95 | -7.46 | -1.24 | Mean value in Relief Arm minus Mean value in Referral Arm. | Superiority |
| Domain 3 |
|
| t-test, 2 sided |
| 0.001 |
| Mean Difference (Final Values) |
| 0.52 |
| 2-Sided |
| 95 |
| 0.21 |
| 0.83 |
Mean value in Relief Arm minus Mean value in Referral Arm. |
| Superiority |
| Domain 3 | t-test, 2 sided | 0.002 | Mean Difference (Final Values) | 0.96 | 2-Sided | 95 | 0.36 | 1.56 | Mean value in Relief Arm minus Mean value in Referral Arm. | Superiority |