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CTRI Number  CTRI/2025/04/084163 [Registered on: 04/04/2025] Trial Registered Prospectively
Last Modified On: 13/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral
Other (Specify) [Neuropsychological (Cognitive)]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Smartphone App for Cognitive Dysfunction in Anxiety Disorders 
Scientific Title of Study   Smartphone App-based Integrated Cognitive Control Training for Cognitive Dysfunction in Anxiety Disorders: a Multi-site Randomized Control Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Himani Kashyap 
Designation  Additional Professor  
Affiliation  National Institute of Mental Health and Neuro Sciences (NIMHANS) 
Address  Level 3 MVG building Department of Clinical Psychology National Institute of Mental Health and Neuro Sciences (NIMHANS) Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  08026995941  
Fax    
Email  himani@nimhans.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Jaisoorya TS 
Designation  Professor 
Affiliation  National Institute of Mental Health and Neuro Sciences (NIMHANS) 
Address  Department of Psychiatry National Institute of Mental Health and Neuro Sciences (NIMHANS) Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  08026995271  
Fax    
Email  tsjaisoorya@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr YC Janardhan Reddy  
Designation  Professor  
Affiliation  National Institute of Mental Health and Neuro Sciences (NIMHANS) 
Address  Department of Psychiatry National Institute of Mental Health and Neuro Sciences (NIMHANS) Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  08026995278  
Fax    
Email  ycjreddy@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research (ICMR), V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi India-110 029.  
 
Primary Sponsor  
Name  Indian Council of Medical Research (ICMR) 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi-110 029. India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Snehil Gupta  AIIMS Bhopal  AIIMS Campus Rd, AIIMS Campus, Saket Nagar, Habib Ganj, Bhopal, Madhya Pradesh 462026
Bhopal
MADHYA PRADESH 		 9582068628

snehil2161@gmail.com 
Dr Himani Kashyap  National Institute of Mental Health and Neuro Sciences (NIMHANS)  Departments of Psychiatry and Clinical Psychology, Hosur Road / Marigowda Road, (Lakkasandra, Wilson Garden) Bangalore – 560029 Karnataka, India.
Bangalore
KARNATAKA 		 08026995941

himani@nimhans.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
All India Institute od Medica Sciences Bhopal Institutional Human Ethics Committee  Approved 
NIMHANS Ethics Committee (Behavioural Sciences Division)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F400||Agoraphobia, (2) ICD-10 Condition: F401||Social phobias, (3) ICD-10 Condition: F402||Specific (isolated) phobias, (4) ICD-10 Condition: F410||Panic disorder [episodic paroxysmal anxiety], (5) ICD-10 Condition: F411||Generalized anxiety disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Integrated Cognitive Control Training  The 8-week ICCT will comprise cognitive stimulation tasks, metacognitive strategy monitoring and generalization exercises, using a smartphone app, Cogtrain, to be modified and upgraded in this study. The intervention will include approximately 24 hours of training in total across 8 weeks, divided into therapist-guided (weekly 1 hour), and homework (total 2 hours per week, spread across the week). Therapist-guided sessions will be conducted online or in-person.  
Comparator Agent  Treatment As Usual (TAU)  TAU will include medications, psychoeducation and routine follow-ups on an outpatient basis for 8 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Current DSM 5 diagnosis of anxiety disorders (generalized anxiety disorder, social anxiety disorder, panic disorder, or phobic anxiety disorders),
Stable on medication or off medication (no changes to medication during the course of the study or in preceding 3 months)
Aged 18 - 50 years,
Minimum 7th std education with working knowledge in English
Amenable for neurocognitive assessments and training
Access to smartphone
 
 
ExclusionCriteria 
Details  History of severe mental disorders (bipolar or psychotic disorders),
History of central nervous system conditions (traumatic brain injury tumours, epilepsy, stroke, degenerative disorders),
Comorbid substance/behaviour addictions (alcohol and other drugs except nicotine, gambling/gaming/technology addiction)
History of developmental disorders including intellectual disability
Exposure to more than 3 sessions of structured psychotherapy in preceding 3 months,
Exposure to brain stimulation in the preceding 3 months
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Measure of anxiety severity
 		 Pre: Week 1, Mid: Week 4-6, Post: Week 10-12 and Follow-up: Week 20-24(if feasible) 
 
Secondary Outcome  
Outcome  TimePoints 
Socio-occupational functioning
Cognitive functions
haemodynamic correlates and functional connectivity (NIMHANS site only)
Intervention feasibility and acceptance metrics 		 Pre: Week 1, Mid: Week 4-6, Post: Week 10-12 and Follow-up: Week 20-24(if feasible) 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [himani@nimhans.ac.in].

  6. For how long will this data be available start date provided 01-07-2028 and end date provided 01-06-2031?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Anxiety disorders (ADs; disorders characterized by debilitating anxiety) may be a ‘silent epidemic’ affecting approximately 3-4% of India’s population, and among the top worldwide causes of disability. Cognitive deficits (e.g., executive functions and memory) may contribute to socio-occupational dysfunction, and even longitudinally predict development of anxiety symptoms. Cognitive training may enhance cognitive and clinical outcomes through targeting underlying neural mechanisms. Attempts in ADs are few, and show limited improvements in untrained domains.

Research gap:

  • No published research on cognitive training in ADs in India. Existing international studies are sparse, mostly analog sample studies.

  • Existing studies of cognitive training demonstrate limited transfer of effects, possibly due to methodological issues.

  • In India, existing cognitive training programs for other disorders cannot be used in ADs because - a. developed for severe deficits (e.g., brain injuries), not suited for ADs; b. lack of flexibility for individual differences in ability levels; c. not suited for self-administration, i.e, require trained neuropsychologist to deliver and/or carer supervision

The investigators have previously piloted a smartphone app-based Integrated Cognitive Control Training (ICCT) intervention, demonstrating improvements on cognitive control, and transfer to other untrained domains. Since ICCT focusses on the transdiagnostic component of cognitive control, with dose, duration and methods informed by evidence-based guidelines of CT, it is well-suited for extension to ADs.

The current proposal aims to compare ICCT (n=50) against Treatment-as-usual (TAU; n=50) in a randomized control design with multimodal assessments at baseline, mid-, post-intervention, and follow-up. The 8-week ICCT will comprise cognitive stimulation tasks, metacognitive strategy monitoring and generalization exercises, using a smartphone app, Cogtrain, to be modified and upgraded in this study. It is hypothesized that ICCT, compared to TAU, will lead to significant gains on cognitive control, as well as other cognitive domains (processing speed, planning, memory, visuospatial functions, metacognitive self-regulation), symptom severity measures, socio-occupational functioning, cognitive task-based functional connectivity, and hemodynamic alterations after 8 weeks.  
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