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

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Pain, Chronic

Treatments: Behavioral: Daily Self-Monitoring Surveys; Behavioral: Daily Self-Monitoring Surveys + Contingency Management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03962491

HM20013828

1R36DA046671 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

Daily Self-Monitoring Surveys

Other group

Description:

Asked to complete daily self-monitoring surveys.

Treatment:

Behavioral: Daily Self-Monitoring Surveys

Daily Self-Monitoring Surveys + Contingency Management

Experimental group

Description:

Asked to complete daily self-monitoring surveys, with opportunity for monetary rewards.

Treatment:

Behavioral: Daily Self-Monitoring Surveys + Contingency Management