Development and Clinical Evaluation of a Digital Blended Therapy Intervention for Self- Monitoring in Work-Related Stress Disorders

Objective: Clinical evaluation of the SELBA (Self-recognition, Understanding, and Monitoring of Work-related Stressors and Strain) formative risk assessment for blended therapy, a Class IIa medical device web application into psychiatric-psychotherapeutic treatment for patients with work-related stress disorders.

Method: Iterative usability engineering following IEC 62366, the international standard that specifies a process for applying usability engineering to design and development of medical devices to ensure they are safe and effective for users, across five phases. N=230 patients at Clinic Gais AG, Switzerland; n=17 provided explicit research consent for detailed analysis. Evaluation assessed accessibility, user-friendliness, aesthetics, adherence, perceived benefit, and feasibility through interviews, surveys, and usage logs.

Results: SELBA comprises five modules: early warning signs (21 BDI-II items plus 2 somatic items) with Bayesian risk modeling, explanation models as digital boundary objects, activities scheduling, therapy goals tracking, and crisis plan. Adherence analysis revealed three groups: sustained use (24%), intermittent use requiring therapeutic support (47%), and non-use (29%). Mean BDI-II sum scores decreased from M=21.3 (SD=8.7) at admission to M=11.4 (SD=6.2) at discharge (d=1.32) but increased to M=17.8 (SD=9.1) post-discharge in the intermittent-use group. Usability ratings were high (System Usability Scale M=73.2, SD=12.1).

Conclusions: blended therapy processes through boundary objects can be designed with sufficient accessibility for collaborative therapeutic use while representing complex work-related risk factors. SELBA demonstrates high acceptability and feasibility during active treatment. However, sustained post-treatment engagement (24%) requires continuous therapeutic support. This usability study establishes feasibility; future randomized controlled trials must assess effectiveness for relapse prevention as primary outcome.

Keywords: Blended therapy; Digital health; Work-related stress; Occupational mental health; Boundary objects; mHealth; Usability

Highlights:

• Digital boundary objects enable collaborative visualization of complex work stress

• High usability of digital health systems requires continued/blended therapeutic involvement

• Blended therapy shows high feasibility but limited post-treatment adherence

• Interprofessional integration (nursing staff) essential for implementation

• Formative risk assessment principles successfully integrated into digital tool