Currently submitted to: JMIR Formative Research
Date Submitted: Sep 15, 2026
Open Peer Review Period: Sep 15, 2026 - Nov 10, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Development and Formative Evaluation of a Self-Guided Digital Cognitive Behavioral Therapy Intervention for Anxiety and Depression in Women Survivors of Sexual Violence: A Mixed Methods Pilot Study
ABSTRACT
Background:
Sexual violence is associated with persistent anxiety and depressive symptoms, while multiple barriers may limit access to specialized psychological care. Self-guided digital interventions may expand access, but their usability, acceptability, and contextual relevance should be established before clinical efficacy is evaluated.
Objective:
This study aimed to develop and formatively evaluate a self-guided digital intervention based on cognitive behavioral therapy (CBT) and a gender-informed approach for women survivors of sexual violence, focusing on usability, acceptability, retention, and exploratory changes in depression and anxiety symptoms.
Methods:
We conducted a mixed methods pilot study with a single-group pre-post component. The intervention comprised 8 self-guided modules covering psychoeducation, emotional validation and regulation, cognitive flexibility, problem solving, assertive communication, behavioral activation, and relapse prevention. Of 56 women who registered, 47 were eligible, 31 initiated the intervention, and 13 completed all modules and postintervention assessments. Usability and acceptability were assessed using quantitative measures and open-ended questions. Changes in depression and anxiety symptoms were explored using the Wilcoxon signed-rank test.
Results:
Among the 13 participants who completed the intervention, usefulness and content received the highest usability rating (mean 3.77/4, SD 0.37), followed by functionality and clarity (mean 3.54, SD 0.51) and design and navigation (mean 3.33, SD 0.46). All participants described the content as useful and reported favorable aspects of usability or navigation, and 9/13 (69.2%) described experiences of calm, support, empathy, or validation. The main areas for improvement involved technological barriers (8/13, 61.5%), multimedia resources (7/13, 53.8%), and the need for feedback or support (5/13, 38.5%). Mean depression scores decreased from 16.38 (SD 12.86) to 10.92 (SD 11.63; W=13, Z=-2.04, P=.041, r=0.57), whereas mean anxiety scores decreased from 15.85 (SD 12.25) to 11.92 (SD 10.48; W=17, Z=-1.43, P=.154, r=0.40). The completion rate was 27.7% among eligible participants and 41.9% among those who initiated the intervention.
Conclusions:
Among participants who completed the program, the intervention showed favorable usability and acceptability. However, substantial attrition and technological difficulties indicate the need to optimize the user experience and support mechanisms before larger-scale evaluation. The observed clinical changes are exploratory and do not constitute evidence of efficacy.
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