Smartphone app-based Integrated Cognitive Control Training for Anxiety Disorders: Study protocol for a Multi-site Randomized Control Trial

BackgroundCognitive deficits in anxiety disorders (ADs) contribute to clinical and socio-occupational dysfunction, necessitating targeted interventions. NoveltyIntegrated Cognitive Control Training (ICCT), a novel intervention, has demonstrated benefits in other disorders, however, remains unexplored in ADs. With its process-specific training and multi-pronged exercises for stimulation, metacognitive training and generalization, it has potential for enhancing cognitive functions in ADs. ObjectivesThis paper describes the study protocol for a multi-site randomized controlled trial (RCT) to test efficacy of ICCT in individuals with ADs. MethodsAdults diagnosed with ADs (n=100) will be recruited across two sites. Following baseline assessments, they will be randomized to either ICCT (8 weekly sessions) or Treatment As Usual (TAU). ICCT will be delivered through once-weekly therapist-guided, and smartphone app-based ( Cogtrain) homework (20-30 mins, 4-6 times per week). Multimodal assessments will be carried out at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and follow-up (20-24 weeks). The primary measure comprises Hamilton Anxiety Rating Scale, with secondary measures of Work and Social Adjustment Scale (socio-occupational functioning), neuropsychological tests (attention, memory and executive functions) and functional Magnetic Resonance Imaging of the cognitive control circuits. Intervention feasibility and acceptance metrics (response rate, intervention relevance) will also be recorded. Quality assurance and ethical procedures will be documented. Expected outcomeThe ICCT is expected to enhance cognitive functioning in adults with ADs, in addition to symptom reduction, changes in underlying neural circuits of cognitive control and improve overall functioning. Digital delivery through a smartphone app may provide a cost-effective and scalable intervention, useful in resource-constrained settings. Key MessagesThis multi-site randomized controlled trial evaluates a novel, smartphone-delivered Integrated Cognitive Control Training (ICCT) program for adults with anxiety disorders, targeting core cognitive deficits that contribute to functional impairment. By combining therapist-guided sessions with app-based training and multimodal assessments, the study examines both clinical and neural outcomes. Findings are expected to inform the scalability and feasibility of process-based digital cognitive interventions for anxiety disorders, particularly in resource-limited settings. Protocol RegistrationTrial registry name: Clinical Trial Registry of India URL: https://ctri.nic.in/Clinicaltrials/************** Registration number: CTRI/202*/**/******