Clinical trial NCT06000007: Digital Therapeutic for Chronic Pain Feasibility Study
Official title: Development and Implementation of a Behavioral Digital Therapeutic Designed to Support, Educate, Screen and Remotely Monitor Patients with Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Pain
Keywords: chronic pain
primary care
digital therapeutic
mobile app
pain function
pain interference
psychotherapy
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2023-08-21
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control feasibility study with two arms: intervention arm vs. control arm
Primary purpose: TREATMENT

Brief summary: The investigators will conduct a 2-arm randomized control feasibility study to evaluate: 1) the feasibility of using the mobile app and an optional activity tracker, 2) the feasibility of conducting a 2-arm trial, and 3) estimate the effect size for planning for a larger efficacy trial based on our primary outcomes. The intervention arm will test a mobile app that aims to help people reduce pain interference who have chronic pain, as well as mental health issues with depression and anxiety. Participants in the intervention arm will also have the option to sense health data with a tracker that integrates with the app, which will inform the feasibility of this feature.

Detailed description: This study will evaluate the existing 2Morrow Chronic Pain Self-Management Program, in the form of a mobile app, as a digital therapeutic for improving patients' pain self management and function who suffer from chronic pain. Specifically, the investigators will conduct a 2-arm randomized control feasibility study to evaluate: 1) the feasibility of using the mobile app and an optional activity tracker, 2) the feasibility of conducting a 2-arm trial, and 3) estimate the effect size for planning for a larger efficacy trial based on our primary outcomes. The intervention arm will test a mobile app that aims to help people reduce pain interference who have chronic pain, as well as mental health issues with depression and anxiety. Participants in the intervention arm will also have the option to sense health data with a tracker that integrates with the app, which will inform the feasibility of this feature.

Eligibility criteria: Inclusion Criteria:

* \>=18 years old
* at least one ICD pain related diagnosis noted in the electronic health record (EHR)
* at least 2 visits in a primary care clinic with at least one in the last 12 months
* willing to use a mobile app in English
* T-score for the PROMIS brief pain inventory of \>= 55
* access to a smartphone
* willing to download and use a mobile app daily

Exclusion Criteria:

* current cancer related diagnosis (to exclude cancer related chronic pain)
* plans for surgery in next 3 months
* pregnant
* currently receiving hospice care

Primary outcomes:
measure: PROMIS Pain Interference Scale - Short Form 6b
timeFrame: will be measured at baseline, 1 month, 3 months, and 6 months after enrollment (and start of intervention in the intervention arm)
Secondary outcomes:
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: will be measured at baseline, 1 month, 3 months, and 6 months after enrollment (and start of intervention in the intervention arm)
measure: Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: will be measured at baseline, 1 month, 3 months, and 6 months after enrollment (and start of intervention in the intervention arm)
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Primary Care
state: Washington
Study officials:
affiliation: University of Washington
name: Kari A Stephens, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stephens, K. A., Ma, K., Keiser, B., Prado, M., Zhang, Y., West, I., Hsu, C., Anastas, T., Zbikowski, S., Waters, D., & Masterson, J. (2024, August). Improving chronic pain through use of a digital behavioral health app. Abstract and poster presented at the American Psychological Association Annual Convention, Seattle, WA.