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Mobile-Based Contingency Management to Promote Daily Self-monitoring in Primary Care Patients

Using Mobile-based Contingency Management to Promote Daily Self-monitoring of Pain Severity and Prescription Opioid Use in a Primary Care Sample of Chronic Pain Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03962491
Acronym
ProMPT
Enrollment
81
Registered
2019-05-24
Start date
2020-01-24
Completion date
2021-04-14
Last updated
2022-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Chronic

Brief summary

This project examines the efficacy and feasibility of contingency management (CM), delivered using a novel, fully automated CM app (DynamiCare Rewards), to promote daily self-monitoring of pain symptom severity and related variables (e.g., mood, sleep), as well as Rx opioid, alcohol, marijuana, cannabidiol (CBD), and Rx benzodiazepine use in a sample of chronic pain patients. The project will conduct a 2-arm randomized clinical trial (RCT) comparing those receiving reinforcement escalating with continuous performance of the target behavior (CM group) vs those asked to complete the survey but will not be incentivized (C group).

Detailed description

Prescription (Rx) opioid misuse is a significant public health problem and the CDC has declared an opioid epidemic (Dowell, Haegerich, & Chou, 2016). Chronic pain patients, often prescribed opioids for pain management, represent a particularly vulnerable population (e.g., Boscarino et al., 2011). Responsible opioid prescribing depends on effective identification of misuse and comprehensive understanding of pain-related variables (Dowell, Haegerich, & Chou, 2016). Self-report tracking via smartphone apps is a promising solution, but difficulties with adherence have been found to impede the use of remote self-monitoring among chronic pain patients (e.g., Jamison et al., 2016), even with the inclusion of non-monetary rewards (Jamison et al., 2017). One robust strategy for improving adherence is contingency management (CM). While CM has been widely used in research, the translation to clinical practice has met with resistance due, in large part, to practical barriers (e.g., Carroll, 2014). As a Stage 1 behavioral therapies development project (Rounsaville et al., 2001), the goal of this study is to examine the efficacy and feasibility of CM, delivered using a novel, fully automated CM app (DynamiCare), to promote daily self-monitoring of pain symptom severity and related variables (e.g., mood, sleep), as well as Rx opioid, alcohol, marijuana, cannabidiol (CBD), and Rx benzodiazepine use in a sample of chronic pain patients. The target behavior will be objectively defined as completing daily self-monitoring surveys via the app for which those randomized to CM will earn incentives. Participants will complete baseline assessment, followed by random assignment to either the experimental (CM) or control (C) group. All participants will then download the app onto their smartphone and be provided with instruction in its use. Based on the work by Petry et al. (2005) and Olmstead and Petry (2009), the CM group will receive reinforcement escalating with continuous performance of the target behavior while the C group will be asked to complete the survey, but will not receive incentivizes. Both groups will receive reminders to complete the daily survey. Follow-up assessments (including behavioral and psychological measures) will occur at intervention completion (28-days post-randomization) and both CM and C group members will be compensated for their time and effort. The specific aims of this project are to: 1) Compare number of completed daily self-monitoring surveys in CM and C groups; 2) Compare longest sustained period of daily survey completion in CM and C groups; 3) Examine agreement between daily survey and 28-day follow-up visit reports of Rx opioid, alcohol, marijuana, cannabidiol (CBD), and Rx benzodiazepine use in CM and C groups; 4) Examine feasibility and acceptability of CM app implementation targeting self-monitoring of pain severity, related factors, and Rx opioid, alcohol, marijuana, cannabidiol (CBD), and Rx benzodiazepine use; and 5) Estimate effect-size to be used to perform power analyses and sample size calculations as part of the design of a larger RCT.

Interventions

BEHAVIORALDaily Self-Monitoring Surveys + Contingency Management

Asked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app, with the opportunity for monetary rewards for completing daily surveys.

BEHAVIORALDaily Self-Monitoring Surveys

Asked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Virginia Commonwealth University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. at least 18 years of age; 2. own a study-compatible smartphone (iPhone or Android device); 3. report non-cancer related chronic pain (consistent daily pain) for 3 months or greater; 4. able to provide informed consent for study participation; 5. used prescription opioids in the past 30 days; and 6. having ever been prescribed 1 or more opioid medication(s) for pain management.

Exclusion criteria

1. currently pregnant; 2. presenting with language barriers, cognitive impairment, or serious medical or psychiatric illness that in the opinion of the Investigator would preclude them from providing informed consent or participating in the study; and 3. visual impairment or motor impairment that would interfere with use of a smartphone.

Design outcomes

Primary

MeasureTime frameDescription
Number of Daily Self-monitoring Surveys Completed28-day daily survey periodNumber of days daily surveys completed
Longest Period of Sustained Adherence to Daily Survey Completion28-day daily survey periodLargest number of consecutive days wherein daily surveys were completed

Secondary

MeasureTime frameDescription
CM App Acceptability28-day follow-upCM App Acceptability was measured using a 8 item scale asking about experiences using the app. Each item was rated on a 0 - 10 Likert scale with higher scores indicating more positive responses. Scores for each item are reported separately.
Daily Survey Completion Time28-day daily survey periodMean time to complete daily surveys

Other

MeasureTime frame
Agreement Between Daily Survey and 28-day Follow-up Reports of Rx Benzodiazepine Use28-day daily survey period to 28-day follow-up
Agreement Between Daily Survey and 28-day Follow-up Reports of Marijuana Use28-day daily survey period to 28-day follow-up
Agreement Between Daily Survey and 28-day Follow-up Reports of Cannabidiol Use28-day daily survey period to 28-day follow-up
Agreement Between Daily Survey and 28-day Follow-up Reports of Alcohol Use28-day daily survey period to 28-day follow-up
Agreement Between Daily Survey and 28-day Follow-up Reports of Rx Opioid Use28-day daily survey period to 28-day follow-up

Countries

United States

Participant flow

Participants by arm

ArmCount
Daily Self-Monitoring Surveys
Asked to complete daily self-monitoring surveys. Daily Self-Monitoring Surveys: Asked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app.
35
Daily Self-Monitoring Surveys + Contingency Management
Asked to complete daily self-monitoring surveys, with opportunity for monetary rewards. Daily Self-Monitoring Surveys + Contingency Management: Asked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app, with the opportunity for monetary rewards for completing daily surveys.
46
Total81

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up45

Baseline characteristics

CharacteristicDaily Self-Monitoring SurveysTotalDaily Self-Monitoring Surveys + Contingency Management
Age, Continuous45.71 years
STANDARD_DEVIATION 12.39
44.76 years
STANDARD_DEVIATION 14.55
44.02 years
STANDARD_DEVIATION 16.12
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants7 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
32 Participants72 Participants40 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants2 Participants2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Black or African American
2 Participants4 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants3 Participants3 Participants
Race (NIH/OMB)
White
32 Participants72 Participants40 Participants
Region of Enrollment
United States
35 participants81 participants46 participants
Sex/Gender, Customized
Female
28 Participants61 Participants33 Participants
Sex/Gender, Customized
Male
7 Participants19 Participants12 Participants
Sex/Gender, Customized
Other
0 Participants1 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Longest Period of Sustained Adherence to Daily Survey Completion

Largest number of consecutive days wherein daily surveys were completed

Time frame: 28-day daily survey period

ArmMeasureValue (MEAN)Dispersion
Daily Self-Monitoring SurveysLongest Period of Sustained Adherence to Daily Survey Completion17.11 number of daysStandard Deviation 9.36
Daily Self-Monitoring Surveys + Contingency ManagementLongest Period of Sustained Adherence to Daily Survey Completion22.07 number of daysStandard Deviation 7.76
Primary

Number of Daily Self-monitoring Surveys Completed

Number of days daily surveys completed

Time frame: 28-day daily survey period

ArmMeasureValue (MEAN)Dispersion
Daily Self-Monitoring SurveysNumber of Daily Self-monitoring Surveys Completed23.06 Surveys completedStandard Deviation 6.97
Daily Self-Monitoring Surveys + Contingency ManagementNumber of Daily Self-monitoring Surveys Completed26.09 Surveys completedStandard Deviation 3.85
Secondary

CM App Acceptability

CM App Acceptability was measured using a 8 item scale asking about experiences using the app. Each item was rated on a 0 - 10 Likert scale with higher scores indicating more positive responses. Scores for each item are reported separately.

Time frame: 28-day follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Daily Self-Monitoring SurveysCM App AcceptabilityUseful6.58 score on a scaleStandard Deviation 2.17
Daily Self-Monitoring SurveysCM App AcceptabilityBothersome6.95 score on a scaleStandard Deviation 2.16
Daily Self-Monitoring SurveysCM App AcceptabilityOverall satisfaction7.78 score on a scaleStandard Deviation 1.48
Daily Self-Monitoring SurveysCM App AcceptabilityWilling to use7.09 score on a scaleStandard Deviation 2.43
Daily Self-Monitoring SurveysCM App AcceptabilityAppealing7.13 score on a scaleStandard Deviation 2.03
Daily Self-Monitoring SurveysCM App AcceptabilityHelp you cope with pain4.25 score on a scaleStandard Deviation 2.15
Daily Self-Monitoring SurveysCM App AcceptabilityEasy to use7.71 score on a scaleStandard Deviation 1.11
Daily Self-Monitoring Surveys + Contingency ManagementCM App AcceptabilityHelp you cope with pain4.87 score on a scaleStandard Deviation 2.45
Daily Self-Monitoring Surveys + Contingency ManagementCM App AcceptabilityEasy to use6.67 score on a scaleStandard Deviation 1.23
Daily Self-Monitoring Surveys + Contingency ManagementCM App AcceptabilityOverall satisfaction7.31 score on a scaleStandard Deviation 1.49
Daily Self-Monitoring Surveys + Contingency ManagementCM App AcceptabilityUseful6.82 score on a scaleStandard Deviation 2.3
Daily Self-Monitoring Surveys + Contingency ManagementCM App AcceptabilityAppealing7.50 score on a scaleStandard Deviation 1.69
Daily Self-Monitoring Surveys + Contingency ManagementCM App AcceptabilityBothersome5.50 score on a scaleStandard Deviation 3.04
Daily Self-Monitoring Surveys + Contingency ManagementCM App AcceptabilityWilling to use8.11 score on a scaleStandard Deviation 1.05
Secondary

Daily Survey Completion Time

Mean time to complete daily surveys

Time frame: 28-day daily survey period

ArmMeasureValue (MEAN)Dispersion
Daily Self-Monitoring SurveysDaily Survey Completion Time8.71 minutesStandard Deviation 33.03
Daily Self-Monitoring Surveys + Contingency ManagementDaily Survey Completion Time5.78 minutesStandard Deviation 9.66
Other Pre-specified

Agreement Between Daily Survey and 28-day Follow-up Reports of Alcohol Use

Time frame: 28-day daily survey period to 28-day follow-up

Other Pre-specified

Agreement Between Daily Survey and 28-day Follow-up Reports of Cannabidiol Use

Time frame: 28-day daily survey period to 28-day follow-up

Other Pre-specified

Agreement Between Daily Survey and 28-day Follow-up Reports of Marijuana Use

Time frame: 28-day daily survey period to 28-day follow-up

Other Pre-specified

Agreement Between Daily Survey and 28-day Follow-up Reports of Rx Benzodiazepine Use

Time frame: 28-day daily survey period to 28-day follow-up

Other Pre-specified

Agreement Between Daily Survey and 28-day Follow-up Reports of Rx Opioid Use

Time frame: 28-day daily survey period to 28-day follow-up

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026