Currently accepted at: JMIR Research Protocols
Date Submitted: May 24, 2026
Date Accepted: Oct 28, 2026
This paper has been accepted and is currently in production.
It will appear shortly on 10.2196/102297
The final accepted version (not copyedited yet) is in this tab.
Optimizing a digital ultra-brief treatment for patients waiting for face-to-face psychotherapy: Study protocol for the OPTIBRIEF factorial trial
ABSTRACT
Background:
Depressive and anxiety disorders contribute substantially to the global burden of disease. Many patients wait a long time for outpatient psychotherapy, during which symptoms may persist or worsen. Digital interventions may help bridge this gap, and ultra-brief treatments (UBTs) are especially promising because they are scalable, low-threshold, and require few resources. However, it remains unclear how such interventions should be constructed to maximize reductions in symptoms of depression and anxiety and meet the needs of patients waiting for face-to-face (f2f) psychotherapy.
Objective:
This study aims to optimize a digital UBT for patients waiting for outpatient psychotherapy by testing three intervention components: therapeutic content (resource-focused vs. problem-focused), guidance (with vs without human support), and expectation-optimization elements (with vs without). The primary goal is to identify the most promising UBT configuration for reducing anxiety and depressive symptoms. The study will also examine patient experiences with the UBT to gain knowledge on how a UBT should be constructed to best suit their needs.
Methods:
This randomized, balanced 2 × 2 × 2 factorial trial includes eight conditions. A total of 312 participants waiting for outpatient f2f-psychotherapy who meet diagnostic criteria for a depressive disorder, anxiety disorder, or both will be randomized. The primary endpoint is anxiety and depressive symptom severity 2 weeks after randomization, measured with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). Secondary outcomes include depression symptoms, quality of life, anxiety symptoms, treatment satisfaction, negative effects, treatment expectations, perceived resource activation and problem mastery, and working alliance. Assessments will be conducted at baseline and 2, 5, 9, and 24 weeks after randomization. Qualitative interviews on patient experiences with the UBT will be conducted with a subsample (N = 40) following the 9-week assessment.
Results:
Recruitment started in September 2025. As of the date of manuscript submission in May 2026, 108 participants have been randomized and recruitment is ongoing. First results are expected in late 2027.
Conclusions:
This trial examines how a digital UBT should be constructed to reduce depression and anxiety symptoms in patients waiting for face-to-face therapy. The factorial design will help identify which components contribute to symptom improvement. Findings are expected to guide the development of an optimized, scalable digital intervention for future testing and potential integration into routine care. Clinical Trial: ClinicalTrials.gov, NCT07167849.
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Copyright
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