| CTRI Number |
CTRI/2025/01/079027 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
16/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cognitive Intervention] |
| Study Design |
Other |
|
Public Title of Study
|
Cognitive Interventions in First Episode Psychosis-RCT |
|
Scientific Title of Study
|
A Randomized Controlled Trial of cognitive interventions in Patients with First Episode Psychosis to improve cognitive outcomes. |
| 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 Swapnajeet Sahoo |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Education & Research, Chandigarh |
| Address |
Department of Psychiatry
PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8872727744 |
| Fax |
|
| Email |
swapnajit.same@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swapnajeet Sahoo |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Education & Research, Chandigarh |
| Address |
Department of Psychiatry
PGIMER, Chandigarh
CHANDIGARH
160012
India |
| Phone |
8872727744 |
| Fax |
|
| Email |
swapnajit.same@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swapnajeet Sahoo |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Education & Research, Chandigarh |
| Address |
Department of Psychiatry
PGIMER, Chandigarh
CHANDIGARH
160012
India |
| Phone |
8872727744 |
| Fax |
|
| Email |
swapnajit.same@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
AIIMS Campus Temple, Ansari Nagar East, New Delhi, Delhi 110029 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Swapnajeet Sahoo |
Postgraduate Institute of Medical Education and Research (PGIMER), sector 12. Chandigarh |
Department of Psychiatry
New OPD Room No. 217
Chandigarh
CHANDIGARH |
8872727744
swapnajit.same@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh- I nstitutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20||Schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cognitive Intervention |
Domains: Attention, Working Memory (WM), Cognitive Flexibility (CF), Response Inhibition (RI), Memory (M) Social Cognition (SC).
12 weeks of cognitive intervention with 2 therapist delivered sessions per week and 5 days of home work assignments or worksheets supervised by the caregiver.
WEEK 1 and WEEK 2 will focus on ATTENTION with Target cancellation task for selective attention and Grain sorting task for information processing speed and focused attention.
WEEK 3 and WEEK 4 will focus on WORKING MEMORY with Digit Forward-Letter Forward task, Digit Backward-Letter Backward task and Shopping list task.
WEEK 5 will focus on COGNITIVE FLEXIBILITY with the Card Sorting Task.
WEEK 6 will focus on RESPONSE INHIBITION with the Design colouring Task.
WEEK 7 and WEEK 8 will focus on MEMORY with the Paired word association learning Task and Vocabulary Recall Task.
WEEK 9 to WEEK 12 will focus on SOCIAL COGNITION with tasks of Defining emotions, Identifying emotions, Guessing the emotions, Identifying facial expressions, Emotional attention shaping and Basic Social skills training.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with schizophrenia as per DSM-5 criteria5, with duration of illness less than 5 years
Currently in clinical remission as defined by Andreasen et al 20056.
|
|
| ExclusionCriteria |
| Details |
Patients who were not in clinical remission
Those with comorbid organic brain syndrome or intellectual disability
Those refuse to consent for the study
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Equal to or more than for FOToM 0.98 SOToM 0.82 FPCI 0.91 SPI 0.89 SPI High Intensity 0.92 SPI Low Intensity 0.86 NSPI 0.93 NSPI High Intensity 0.94 NSPI Low Intensity 0.87 DF 10.04 DB 7.45 COWA Average New words 11.66 AVLT LTPR 93.45 Immediate Recall 13.33 Delayed Recall 13.41 Total Learning score 60 Interference 8.12 Hits 14.66 SPM IQ 122.12
Equal to or Less than for CTMT Part A 29.54 Part B 69 SCWT score 42.16 Misses 0.33 False Alarms 0.41
|
12 weeks post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Level of functioning, disability and quality of life from baseline scores |
12 weeks post intervention |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
03/02/2025 |
| 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 - NO
|
Brief Summary
Modification(s)
|
Aim: To evaluate the efficacy of cognitive-based interventions in patients with first episode psychosis and to evaluate if it can improve the overall course and outcome of patients with FEP over the period of 6 months. Objectives: To compare of the level of functioning, psychopathology, social cognitions, neurocognitions, quality of life, stigma, insight, and disability, in patients with FEP at the baseline. To develop cognitive rehabilitation intervention package. To evaluate improvement in cognitive deficits following cognitive interventions after a duration of 6 months vis-Ã -vis in the TAU arm. Methods: This is a randomized control trial for the duration of 3 years. Those randomized to cognitive intervention arm will be assessed at baseline, at the end of the trial and after 6 months to evaluate the effect of cognitive interventions on the overall course and outcome. The sample is being obtained from the patient population attending outpatient or inpatient services of Department of Psychiatry of PGIMER, Chandigarh. The study sample will comprise 300 patients with FEP of which 150 will be randomized to each group (Intervention group and TAU group). Patients in both intervention and non-intervention group will be subjected to Treatment as usual which includes psycho-education, medications and periodic routine follow up. In the intervention group, additional cognitive remediation measures will be provided as per the cognitive deficits of the individual patient. Outcome: The improvement of the level of functioning, psychopathology, social cognitions, neurocognitions, quality of life, stigma, insight, and disability in patients with FEP at the baseline. The development of cognitive rehabilitation intervention package. The evaluation of improvement in cognitive deficits following cognitive interventions after a duration of 6 months vis-Ã -vis in the TAU arm. |