Trial reportJournal of medical Internet research2025
Safety and Efficacy of Modular Digital Psychotherapy for Social Anxiety: Randomized Controlled Trial.
Trial report in Journal of medical Internet research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Safety, Acceptability and Efficacy of Alena, a Modularized CBT-based Mobile App Intervention for Social Anxiety: a Randomised Controlled Trial
Efficacy, Tolerability and Safety of a Smartphone-delivered, Fully Automatic Cognitive Behavioural Therapy Programme for Social Anxiety
Who cites it
1 citing paper in PubMed.
- A cognitive layer architecture to support large-language model performance in psychotherapy interactions.Nature medicine · 2026Trial
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
backgroundSocial anxiety disorder is a common mental health condition characterized by an intense fear of social situations that can lead to significant impairment in daily life. Cognitive behavioral therapy (CBT) has been recognized as an effective treatment; however, access to therapists is limited, and the fear of interacting with therapists can delay treatment seeking. Furthermore, not all individuals respond. Tailoring modular treatments to individual cognitive profiles may improve efficacy. We developed a novel digital adaptation of CBT for social anxiety that is both modular and fully digital without a therapist in the loop and implemented it in the smartphone app Alena.
objectiveThis study aimed to evaluate the safety, acceptability, and efficacy of the new treatment in online participants with symptoms of social anxiety.
methodsIn total, 2 web-based randomized controlled trials (RCTs) comparing individuals with access to the treatment through the app to a waitlist control group were conducted. Participants were recruited on the web and reported Social Phobia Inventory (SPIN) total scores of ≥30. Primary outcomes were safety and efficacy over 6 weeks in 102 women aged 18 to 35 years (RCT 1) and symptom reduction (SPIN scores) after 8 weeks in 248 men and women aged 18 to 75 years (RCT 2).
resultsIn RCT 1, active and control arm adverse event frequency and severity were not distinguishable (intervention: 7/52, 13%; waitlist control: 8/50, 16%; χ
conclusionsThe web-only, modular social anxiety CBT program appeared safe, acceptable, and efficacious in 2 independent RCTs on online patient groups with self-reported symptoms of social anxiety.
trial registrationClinicalTrials.gov NCT05858294; https://clinicaltrials.gov/study/NCT05858294 (RCT 1) and ClinicalTrials.gov NCT05987969; https://clinicaltrials.gov/study/NCT05987969 (RCT 2).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.