Trial reportJMIR mHealth and uHealth2025
Efficacy of a Self-Guided Transdiagnostic Intervention for Adults With Anxiety and Depression: Randomized Controlled Trial.
Trial report in JMIR mHealth and uHealth, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06434883 (Assessment of an App-based Anxiety/Depression Program in a Population With Elevated Anxiety/Depression A Clinical Randomized Controlled Trial), which is not on this map. Not yet cited in PubMed.
What it found
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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.
Assessment of an App-based Anxiety/Depression Program in a Population With Elevated Anxiety/Depression A Clinical Randomized Controlled Trial
Who cites it
0 citing papers in PubMed.
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Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAnxiety and depressive disorders affect hundreds of millions globally, with substantial barriers limiting access to evidence-based treatments like cognitive behavioral therapy. Digital mental health interventions offer potential solutions to improve access to support. However, evidence of efficacy through randomized controlled trials is essential for clinical adoption.
objectiveThis study evaluated the efficacy of the Headspace Anxiety and Depression Program, a digitally delivered 21-session intervention grounded in the Unified Protocol that integrates cognitive behavioral and mindfulness-based strategies to target common drivers of emotional disorders, compared to a waitlist control group. Primary aims were to assess reductions in anxiety (Generalized Anxiety Disorder-7 [GAD-7]) and depression (Patient Health Questionnaire-8 [PHQ-8]) symptoms. Secondary aims examined improvements in sleep quality (Pittsburgh Sleep Quality Index), perceived stress (Perceived Stress Scale-10), mindfulness (Mindful Attention Awareness Scale), and overall well-being (Warwick-Edinburgh Mental Well-Being Scale), as well as clinical remission and treatment response rates.
methodsA fully remote, 2-arm parallel-group randomized controlled trial was conducted with 168 participants (aged ≥18 years) who had clinically significant anxiety (GAD-7≥10) or depression symptoms (PHQ-8≥10). Participants were randomized to either the Headspace Anxiety and Depression Program (n=84) or waitlist control (n=84). The intervention consisted of 21 daily sessions (5-10 minutes each) delivered via the Headspace app. Primary (GAD-7 and PHQ-8) and secondary outcomes (Pittsburgh Sleep Quality Index, Perceived Stress Scale-10, Mindful Attention Awareness Scale, and Warwick-Edinburgh Mental Well-Being Scale) were assessed at baseline, postintervention, and a 3-week follow-up using intention-to-treat analysis with mixed-model ANOVAs.
resultsStudy retention was high, with the majority (154/168, 91.7%) of participants completing the 3-week follow-up visit, and no serious adverse events were reported. Intervention adherence was high, with 82.1% (69/84) in the intervention group completing all 21 sessions. Significant group×time interactions were observed for both primary outcomes (P<.001). The Headspace group showed substantial reductions in anxiety symptoms (GAD-7: 34.5% reduction from baseline: mean 11.9, SD 2.8 to follow-up: mean 7.8, SD 2.3; η
conclusionsThe Headspace Anxiety and Depression Program demonstrated significant efficacy in reducing anxiety and depression symptoms comparable to established treatments. Benefits were sustained at the 3-week follow-up. These findings support the potential of evidence-based transdiagnostic digital mental health interventions to address critical gaps in mental health care delivery.
trial registrationClinicalTrials.gov NCT06434883; https://clinicaltrials.gov/study/NCT06434883.
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