Clinical trial NCT05406791: Technology Enabled Services to Enhance Depression Care
Official title: Technology Enabled Services to Enhance Depression Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Rush University
name: National Institute of Mental Health (NIMH)
First posted: 2022-06-06
Enrollment: 130
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: This study will compare two digital mental health interventions (DMHIs). One DMHI will use an app called Vira (which is a product developed and managed by Ksana Health), along with low intensity coaching provided via phone and both SMS text and in-app messaging. The other DMHI will provide a broad range of information on how to manage symptoms of depression, anxiety, and stress. The DMHI will be evaluated with patients receiving care from Rush University Medical Center's primary care and family medicine clinics, which serve racially, ethnically, and economically diverse communities; evaluations may also be extended beyond Rush patients.

Detailed description: Depression and anxiety are common and impose a tremendous societal burden in terms of cost, morbidity, quality of life, and mortality. Yet, few people are able to obtain adequate or appropriate treatment.

This trial will compare the ability of two digital mental health interventions (DMHIs) to reduce depression and anxiety. One DMHI, called Mood Education App, provides information on depression and a broad range of strategies that are effective in improving symptoms. The other app, called VIRA, uses smartphone sensors to identify a few behavioral markers, including mobility patterns, physical activity, and sleep. The results of these sensed behavioral markers are used to give the participant behavior change recommendations through the Vira app that are expected to result in symptom improvement. The DMHI will include low intensity coaching, which includes one or more brief phone calls and communication via SMS text and in-app messaging. Both treatments are 8-weeks long.

The trial will be conducted within Rush University Medical Center's primary care and family medicine clinics, although recruitment be expanded beyond these clinics.

Eligibility criteria: Inclusion Criteria:

* US Citizen/ Resident
* 13 years or older
* English Speaking
* Owns an Android or iPhone smartphone with an up-to-date operating system
* Has used a smartphone in the last 7 days
* PHQ-8 greater than or equal to 10 and/or GAD-7 greater than or equal to 10

Exclusion Criteria:

* Children under the age of 13
* Severe suicidality (as defined by presence of a plan + intent to act on that plan)

Primary outcomes:
measure: Patient Health Questionaire-9 (PHQ-9)
timeFrame: 12 weeks
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center Department of Psychiatry & Behavioral Sciences
state: Illinois
Study officials:
affiliation: Northwestern University
name: David C Mohr, PhD
role: PRINCIPAL_INVESTIGATOR
References: