| CTRI Number |
CTRI/2017/02/007803 [Registered on: 07/02/2017] Trial Registered Retrospectively |
| Last Modified On: |
03/02/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of family teaching on the attitudes of family members of patients with schizophrenia and the recurrence of illness in patients |
|
Scientific Title of Study
|
Effectiveness of Positive Family Interactions Module on the Expressed Emotion of the Caregivers and Relapse of Patients with Schizophrenia: A Prospective Study in a Selected Psychiatric Inpatient Facility |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Agnes E J |
| Designation |
Professor |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller College of Nursing,
Kankanady,
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8050157831 |
| Fax |
|
| Email |
agnesej2011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Agnes E J |
| Designation |
Professor |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller College of Nursing,
Kankanady,
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8050157831 |
| Fax |
|
| Email |
agnesej2011@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Agnes E J |
| Designation |
Professor |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller College of Nursing,
Kankanady,
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8050157831 |
| Fax |
|
| Email |
agnesej2011@gmail.com |
|
|
Source of Monetary or Material Support
|
| Father Muller Medical College Hospital
Kankanady
Mangalore
575002 |
|
|
Primary Sponsor
|
| Name |
Agnes E J |
| Address |
Father Muller College of Nursing,
Kankanady
Mangalore. |
| Type of Sponsor |
Other [] |
|
|
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 |
| Prof Agnes E J |
Father Muller Medical College Hospital |
Unit No 90 ,Room no 2.Father Muller Mental Health Centre,Father Muller Medical College Hospital,Kankanady,Mangalore
Dakshina Kannada
KARNATAKA |
8050157831
agnesej2011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committtee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Physically and mentally healthy family caregivers of patients with schizophrenia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Positive Family Interactions Module |
Interventional module developed by the investigator for the caregivers of the patients with schizophrenia which includes assessment of knowledge about schizophrenia; information about illness; assessment of burden, emotions and social support; assessment of communication patterns in family; demonstrating communication and interaction patterns avoiding hostility, criticism and emotional over-involvement; assessing coping patterns and teaching adaptive coping skills and coping with stigma. The intervention was carried out in six sessions of 1 hour duration daily for six consecutive days. The intervention was carried out by using lecture, discussion, role play, vignette and modeling with the help of audio visual aids in the in-patient setting. |
| Comparator Agent |
Treatment as usual |
Regular health education on various aspects of care of patients |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with the diagnosis of schizophrenia as per ICD-10.
2. Patients with the caregivers who are willing to come for six-months follow-up.
3. Patients who had at least two hospitalizations and with a duration of at least 6 months of illness
4. Caregivers who are residing with the patient for the last one year
4. Patients and caregivers who can speak English,Malayalam or Kannada
|
|
| ExclusionCriteria |
| Details |
1. Caregivers with physical disability
2. Caregivers with a diagnosed psychiatric disorder
4. Patients with co-morbid medical surgical illness and substance abuse
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PANSS scores of patients |
one, three and six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Expressed emotion scores of family caregivers |
one, three and six months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study approach is evaluative and use quasi experimental design. Sample size is 100, 50 each in the PFIM group and TAU group. The expressed emotion of caregivers are found to cause relapse among patients with schizophrenia. Family interventions are found to be helpful in reducing the expressed emotion, thereby reducing the relapse. |