Clinical trial NCT03783533: Adapting Behavioral Activation to Technology Platform
Official title: Designing and Evaluating an Asynchronous Remote Communication Approach to Behavioral Activation With Clinicians and Adolescents At Risk for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2018-12-21
Enrollment: 11
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This project aims to use an asynchronous remote communities (ARC) approach both to discover the design requirements for adapting Behavioral Activation (BA) to ARC as well as design/build an ARC platform for administering BA. The investigators will test the feasibility of our approach in a small feasibility observational study with clinicians and adolescents.

Detailed description: An estimated 3.1 million adolescents are diagnosed with depression (MDD) each year (SAMHSA, 2016), and adolescent onset MDD is associated with chronic physical, mental and psychosocial disability (Birmaher et al., 1996). However, over 60% of adolescents with MDD do not receive mental health care, and, among those who do, treatment engagement is low (SAMHSA, 2016; Olfson et al., 2003). Behavioral Activation (BA) is an evidence-based psychosocial intervention (EBPI) for individuals with MDD (Dimidjian et al., 2006). While BA holds promise as an effective treatment with adolescents (McCauley et al., 2015, 2016), previous research approaches have found that adolescents may be better reached and engaged through social media, mobile technologies, and other technology platforms (Boyd, 2007; Park \& Calamaro, 2013). In addition, BA requires frequent interaction from patients over time, which can be difficult and costly for clinicians to administer directly. Thus, there is an opportunity to improve usability and engagement of EBPIs via new technology-based tools. Asynchronous Remote Communities (ARC) is a promising technology-based approach for engaging adolescents that capitalizes on the reach of technology while also providing support, social interactions, and motivation to engage. ARCs are technology-mediated groups that use private online platforms to deliver weekly tasks to participants and gather information about perceptions in a format that is lightweight, accessible, usable, and low burden. The investigators aim to use ARC both to discover the design requirements for adapting BA to ARC as well as design/build an ARC platform for administering BA. The investigators will test the feasibility of our approach in a small feasibility study with clinicians and adolescents. The investigators propose the following specific aims:

Aim 1: Use the ARC approach with adolescents, primary care physicians, and mental health specialists to discover target user needs, design constraints and to observe their experience with ARC: The investigators will first use ARC to collect target user (i.e., primary care providers (PCP) and mental health specialists, adolescents at risk for depression) data to understand their needs and the facilitators and barriers to adapting BA to ARC.

Aim 2: Design \& build an ARC platform for BA delivery with adolescents: Once the investigators have a strong understanding of the facilitators and barriers, the investigators will design a platform to use the ARC approach for BA delivery via Slack. The investigators will use an iterative design approach to understand the technical feasibility of the approach, whether and how to automate parts of the BA intervention using chatbots and other custom applications within Slack. The investigators will conduct small, informal usability testing with target users during this stage.

Aim 3: Test feasibility and usability with small pilot groups of adolescent and clinician target users: Once the investigators have a robust enough prototype of the ARC delivery platform for BA, the investigators will conduct a small pilot study with adolescents at-risk for depression and clinicians to assess the feasibility and usability of the approach. The investigators will collect data on the feasibility, usability, user burden, acceptability, and symptom outcomes.

Eligibility criteria: Inclusion Criteria:

* Adolescents with PHQ-9 scores between 5 and 15 (Mild to Moderate Range) who do not report current suicidality (Pine et al., 1999) will be recruited from clinician target users' practice settings.

Exclusion Criteria:

* Current suicidal ideation or PHQ-9 scores that are below or above the cutoff described above for adolescents.

Primary outcomes:
measure: Patient Health Questionnaire-Adolescent (PHQ-8)
timeFrame: Measured within 3-weeks post BA App User Testing
measure: User Burden Scale
timeFrame: Measured within 3-weeks post BA App User Testing
measure: Acceptability of Intervention Measure
timeFrame: Measured within 3-weeks post BA App User Testing
measure: Appropriateness of Intervention Measure
timeFrame: Measured within 3-week post BA App User Testing
measure: Feasibility of Intervention Measure
timeFrame: Measured within 3-week post BA App User Testing
Secondary outcomes:
measure: Platform Engagement
timeFrame: Measuring platform engagement across 35 days of platform use.
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References: