| CTRI Number |
CTRI/2018/05/014095 [Registered on: 24/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
16/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Improvement in Cognitive functioning in Patients with Schizophrenia after cognitive retraining. |
|
Scientific Title of Study
|
Development of a Computerized Neurocognitive Remediation Package And Phase II Trial For Assessment Of Its Efficacy In Cognitive Function Among Patients With Schizophrenia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashima Nehra |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Faculty Chambers, Room # NS-718, VIIth Floor, NEUROSCIENCES CENTER (AIIMS) All India Institute of Medical Sciences New Delhi South DELHI 110029 India
South
DELHI
110029
India |
| Phone |
9810882765 |
| Fax |
|
| Email |
ashimaNwadhawan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Garima Joshi |
| Designation |
PhD Research Scholar |
| Affiliation |
All Indian Institute of Medical Sciences |
| Address |
Faculty Chambers, Room # NS-718, VIIth Floor, NEUROSCIENCES CENTER
All India Institute of Medical Sciences New Delhi
South
DELHI
110029
India |
| Phone |
9582074001 |
| Fax |
|
| Email |
garima.joshi@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Garima Joshi |
| Designation |
PhD Research Scholar |
| Affiliation |
All Indian Institute of Medical Sciences |
| Address |
Faculty Chambers, Room # NS-718, VIIth Floor, NEUROSCIENCES CENTER
All India Institute of Medical Sciences New Delhi
South
DELHI
110029
India |
| Phone |
9582074001 |
| Fax |
|
| Email |
garima.joshi@hotmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Science, Ansari Nagar, New Delhi - 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar, New Delhi - 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ashima Nehra |
All India Institute of Medical Sciences |
Room Number 718, 7th Floor, Department of Clinical Neuropsychology, Neurosciences Centre, AlIIMS
South
DELHI |
9810882765
ashimaNwadhawan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AllMS Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Schizophrenia , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Control group would be provided with Treatment as Usual (TAU), wherein the patients will recieve drug therapy from the department of psychiatry. |
| Intervention |
Experimental Group |
Patient in the experimental group would be given neurocognitive remediation training using a neurocognitive training module package. The modules would target various cognitive domains found to be affected in schizophrenia, inclusion of immediate family members/ caregivers in the therapy would be done, Social skills training would be provided targeting improving communication, short term and long term goal setting, psycho-education, vocational rehabilitation, supportive therapy,and family counseling would be provided along with the cognitive remediation modules. The duration of therapy would be lasting 6 weeks of neurocognitive therapy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Male or female between 18-45 years of age
Meeting the DSM-5 clinical criteria for schizophrenia (APA, 2013)
Patients currently stabilized on same antipsychotics for a period of at least 6 weeks
Patients or primary caregiver with capacity and willingness to give informed consent.
Both in-patients and out-patients
Having basic familiarity & comfort with using computers
Both Right and Left Handed
Education up to Primary level
|
|
| ExclusionCriteria |
| Details |
Presence of past or current co-morbid Axis I disorders including substance abuse/dependence (other than caffeine or nicotine)
Any history of seizure EXCEPT those therapeutically induced by ECT
History suggestive of any neurological or progressive neurological condition.
Having Colour blindness or Blindness
Hearing impairment
Non-consenting individuals
Visual or motor disability which may hinder use of computers.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
- Cognitive function (Time Frame: At baseline, post-intervention and at 3 months follow up.)
- Clinical improvement of cognitive symptoms relative to pre-treatment baseline (Time Frame: At baseline, post-intervention and at 3 months follow up).
- WHODAS II (Time Frame: At baseline, post-intervention and at 3 months follow up).
|
The short term effectiveness would be measured immediately after the completion of the rehabilitation program at 9 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical improvement of negative symptoms (PANSS) relative to pre-treatment baseline.
Global clinical improvement on Clinical global Impression
|
The short term effectiveness would be measured immediately after the completion of the rehabilitation program in the 9th week, after completion of the retraining. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
22/08/2016 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
1. Garima Joshi, Dr Kameshwar Prasad, Dr. Pratap Sharan, Dr. Nand Kumar, Dr. V. Sreenivas, Dr. Ashima Nehra. Long term effectiveness of Cognitive Remediation in Schizophrenia: A Systematic Review. (In Communication: 28.2.18) to Journal of Mental Health and Human Behaviour
2. Is Cognitive Rehabilitation in Schizophrenia Effective?: A Systematic Review Joshi G, Prasad K, Sharan P, Kumar N, Sreenivas V, Nehra A, Indian Journal of Social Psychiatry, Vol 32,Issue 4, Page 449
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patient admitted at AIIMS psychiatry ward diagnosed as Schizophrenia according to DSM – V would be included after proper informed consent of patient and main caregiver.
After taking informed consent, subjects will then be interviewed by investigator to obtain socio-demographic details and history. Screen for inclusion and exclusion criteria. After this, the patients fulfilling the inclusion criteria will be assessed on baseline measures & then be recruited to either the experimental group or control group following a randomization procedure for the trial.In Stage 2, the recruitment for the stage of the Phase II trial will start, which would consist of obtaining an informed consent from the patients as well as the caregivers for participation in the study. This would be followed by randomization, which would lead to assignment of the patient to either experimental or control group. The treatment as usual would follow along with the neurocognitive remediation training in experimental group and sham computer training in control group.
This would be followed by the treatment lasting up to 8-12 sessions of 1 hour each along with psychosocial skills training and separate sessions for family and caregiver education and counselling.
The neurocognitive remediation training will be followed by post-assessment on the same baseline measures and differences will be seen. After the post –assessment the participants will be called for a follow-up session after 3 months in order to see whether the training has generalized and also whether changes(if any) that have occurred because of the retraining are maintained over time. |