Trial Outcomes & Findings for A Behavioral Intervention for Depression and Chronic Pain in Primary Care (NCT NCT03265210)

Last Updated: 2023-03-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

73 participants

Primary outcome timeframe

Baseline, 6, 9, and 12 weeks

Results posted on

2023-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Referral Referral for mental health based on clinical indication.
Overall Study STARTED	50	23
Overall Study COMPLETED	38	14
Overall Study NOT COMPLETED	12	9

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Referral Referral for mental health based on clinical indication.
Overall Study Withdrawal by Subject	7	9
Overall Study Lost to Follow-up	2	0
Overall Study Physician Decision	2	0
Overall Study Adverse Event	1	0

Baseline Characteristics

A Behavioral Intervention for Depression and Chronic Pain in Primary Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Relief n=50 Participants 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.	Referral n=23 Participants Referral for mental health based on clinical indication.	Total n=73 Participants Total of all reporting groups
Age, Continuous	67.28 years STANDARD_DEVIATION 10.09 • n=99 Participants	68.65 years STANDARD_DEVIATION 10.72 • n=107 Participants	67.71 years STANDARD_DEVIATION 10.24 • n=206 Participants
Sex: Female, Male Female	39 Participants n=99 Participants	17 Participants n=107 Participants	56 Participants n=206 Participants
Sex: Female, Male Male	11 Participants n=99 Participants	6 Participants n=107 Participants	17 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=99 Participants	4 Participants n=107 Participants	10 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants n=99 Participants	19 Participants n=107 Participants	63 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	16 Participants n=99 Participants	5 Participants n=107 Participants	21 Participants n=206 Participants
Race (NIH/OMB) White	32 Participants n=99 Participants	14 Participants n=107 Participants	46 Participants n=206 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	4 Participants n=107 Participants	4 Participants n=206 Participants
Region of Enrollment United States	50 participants n=99 Participants	23 participants n=107 Participants	73 participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline, 6, 9, and 12 weeks

Outcome measures

Outcome measures
Measure	Relief n=50 Participants 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.	Referral n=23 Participants Referral for mental health based on clinical indication.
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	20.87 score on a scale Standard Deviation 5.85
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	18.67 score on a scale Standard Deviation 6.88
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	18.00 score on a scale Standard Deviation 7.51
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	16.67 score on a scale Standard Deviation 6.97

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Relief n=50 Participants 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.	Referral n=23 Participants Referral for mental health based on clinical indication.
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	6.57 score on a scale Standard Deviation 2.21
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	6.47 score on a scale Standard Deviation 1.81
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	6.60 score on a scale Standard Deviation 1.59
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	6.67 score on a scale Standard Deviation 1.72
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	16.36 score on a scale Standard Deviation 5.72
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	16.00 score on a scale Standard Deviation 6.02
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	16.21 score on a scale Standard Deviation 6.15
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 6.20	15.40 score on a scale Standard Deviation 6.20

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Relief n=50 Participants 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.	Referral n=23 Participants Referral for mental health based on clinical indication.
Client Satisfaction Questionnaire (CSQ) Domain 1	3.40 score on a scale Standard Deviation 0.81	2.29 score on a scale Standard Deviation 1.70
Client Satisfaction Questionnaire (CSQ) Domain 2	3.72 score on a scale Standard Deviation 0.51	3.20 score on a scale Standard Deviation 0.79
Client Satisfaction Questionnaire (CSQ) Domain 3	3.67 score on a scale Standard Deviation 0.68	2.71 score on a scale Standard Deviation 1.89

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Relief n=18 Participants 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.	Referral n=2 Participants Referral for mental health based on clinical indication.
Change in Mood, as Measured by the Daily Photographic Affect Meter (PAM) Domain 1	2.83 score on a scale Standard Deviation 1.02	2.48 score on a scale Standard Deviation 1.01
Change in Mood, as Measured by the Daily Photographic Affect Meter (PAM) Domain 2	2.58 score on a scale Standard Deviation 0.96	2.94 score on a scale Standard Deviation 0.84

SECONDARY outcome

Timeframe: Daily for 12 weeks

Activities monitoring through a phone application; measuring distance in meters covered daily by the participant during the week.

Outcome measures

Outcome measures
Measure	Relief n=18 Participants 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.	Referral n=2 Participants Referral for mental health based on clinical indication.
Activities Monitoring	20085.61 meters Standard Deviation 174446.40	1654.16 meters Standard Deviation 4581.61

SECONDARY outcome

Timeframe: Daily for 12 weeks

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).

Outcome measures

Outcome measures
Measure	Relief n=18 Participants 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.	Referral n=2 Participants Referral for mental health based on clinical indication.
Activities Monitoring	75947.60 seconds Standard Deviation 23672.34	69557.39 seconds Standard Deviation 29401.19

Adverse Events

Relief

Serious events: 4 serious events

Other events: 3 other events

Deaths: 0 deaths

Referral

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Relief n=50 participants at risk 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.	Referral n=23 participants at risk Referral for mental health based on clinical indication.
Cardiac disorders Hospitalization	4.0% 2/50 • Number of events 2 • 12 weeks (total duration of study)	0.00% 0/23 • 12 weeks (total duration of study)
Psychiatric disorders Hospitalization	2.0% 1/50 • Number of events 1 • 12 weeks (total duration of study)	0.00% 0/23 • 12 weeks (total duration of study)
Respiratory, thoracic and mediastinal disorders Surgery	2.0% 1/50 • Number of events 1 • 12 weeks (total duration of study)	0.00% 0/23 • 12 weeks (total duration of study)
Respiratory, thoracic and mediastinal disorders Hospitalization	2.0% 1/50 • Number of events 1 • 12 weeks (total duration of study)	0.00% 0/23 • 12 weeks (total duration of study)

Other adverse events

Other adverse events
Measure	Relief n=50 participants at risk 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.	Referral n=23 participants at risk Referral for mental health based on clinical indication.
Skin and subcutaneous tissue disorders Rash	6.0% 3/50 • Number of events 3 • 12 weeks (total duration of study)	4.3% 1/23 • Number of events 1 • 12 weeks (total duration of study)

Additional Information

Dimitris Kiosses, PhD

Weill Cornell Medicine

Phone: 914-997-4381

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place