Problem Solving Treatment for Depression: Development and Randomized Controlled Trial of an Internet-Based Support Tool Created Through Human Centered Design (Preprint)

<sec> <title>BACKGROUND</title> While Problem Solving Treatment (PST) for depression is an effective psychotherapy in primary care settings, it is not widely used and clinician fidelity to key elements drops quickly following training. Human Centered Design (HCD) is an approach to understanding the needs of product users which can uncover obstacles through the lens of usability. </sec> <sec> <title>OBJECTIVE</title> We sought to identify usability challenges and implementation solutions for both clinicians who wished to deliver PST and their patients, create a solution using HCD methods, and pilot this solution. </sec> <sec> <title>METHODS</title> As part of the University of Washington ALACRITY Center (NIMH-P50MH115837), we applied the Discover, Design, Build, and Test (DDBT) human-centered design framework. Discover, Design, and Build stages included clinician and patient observations and interviews, and identification of themes and support needs for PST. PST-Aid was created as an internet-based app to overcome obstacles to PST. A Type III hybrid effectiveness/ implementation pilot trial of identified solutions was planned with emphasis on its possible implementation benefits. Randomization to training in PST versus the PST-Aid intervention was planned with a new set of providers other than those involved with HCD co-design activities. Usability was assessed through self-assessed survey. Time to clinician certification in PST, their ongoing fidelity to PST, and clinically significant improvement in patient depression severity (PHQ-9 scores) were the primary outcomes of interest. </sec> <sec> <title>RESULTS</title> A range of HCD methods and rapid prototyping cycles were carried out with co-design clinicians (9 undergoing PST training-as-usual and 10 experienced PST clinicians) and their patients (n = 4), which led to a web-based application that served to support and “scaffold” PST tasks as well as provide decision support for both providers and patients (PST Aid app). Usability was acceptable (SUS = 76), and utility was high based on qualitative assessments. In the Test phase, 11 clinical social workers were randomized to study conditions (7 PST Aid, 4 PST as Usual). All PST Aid clinicians were successfully certified as PST practitioners, while only 33% of PST as usual clinicians achieved certification. More clinicians used PST with their patients in the PST Aid group than those in PST as Usual throughout the study period (72% vs. 50%; p&lt;0.05). More participants in the treatment arm (PST Aid; 67%) had scores that improved to below 10 on the PHQ-9 than participants receiving PST as Usual, but this did not reach statistical significance (Fisher's exact test, p = .07). </sec> <sec> <title>CONCLUSIONS</title> We found that a human centered design approach to technology-based "scaffolding" can support the adoption, reach, and sustained fidelity of an evidence-based clinical intervention. Involving clinicians and patients in the design process may enhance the use and adoption of support tools. This pilot lays the groundwork for a large randomized hybrid effectiveness/implementation trial. </sec> <sec> <title>CLINICALTRIAL</title> ClinicalTrials.gov NCT03516513; https://clinicaltrials.gov/study/NCT03516513 </sec>