| CTRI Number |
CTRI/2025/03/082627 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Application for caretakers of patients with mental illness |
|
Scientific Title of Study
|
Evaluating the efficacy of a computer application vs. group therapy in managing expressed emotion in caretakers of chronic psychiatric patients- a Randomized Controlled 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 |
Jumana Haseen S |
| Designation |
Post graduate |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
1, Integrated clinic, Department of Psychiatry, Saveetha Medical College and Hospital,
Chennai.
Chennai
TAMIL NADU
602105
India |
| Phone |
9443770935 |
| Fax |
|
| Email |
jumanasadique27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shanthi Nambi |
| Designation |
Professor |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
1, Integrated clinic, Department of Psychiatry, Saveetha Medical College and Hospital,
Chennai.
Chennai
TAMIL NADU
602105
India |
| Phone |
9444080307 |
| Fax |
|
| Email |
shanthi.nambi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jumana Haseen S |
| Designation |
Post graduate |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
1, Integrated clinic, Department of Psychiatry, Saveetha Medical College and Hospital,
Chennai.
Chennai
TAMIL NADU
602105
India |
| Phone |
9443770935 |
| Fax |
|
| Email |
jumanasadique27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical college and Hospital |
|
|
Primary Sponsor
|
| Name |
Saveetha Medical College and Hospital |
| Address |
Saveetha Medical College and Hospital, Thandalam, Chennai-602105, Tamilnadu, India. |
| Type of Sponsor |
Private medical college |
|
|
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 S Jumana Haseen |
Saveetha Medical College & Hospital |
IC-1, Department of Psychiatry, Adult Psychiatry
Chennai
TAMIL NADU |
9443770935
jumanasadique27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Evaluating and managing expressed emotions in caretakers of chronic psychiatric patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Computer based application- Untangled mind |
Computer Application Group (intervention): Interactive modules on psychoeducation, communication, emotion regulation, and problem-solving delivered over 8 weeks. |
| Comparator Agent |
Conventional group therapy |
Group Therapy Group (control): Weekly therapist-led sessions for 8 weeks, focusing on similar themes as the app. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Primary caregivers aged 18-65 years.
Must be the primary caregiver for a patient with a chronic psychiatric illness (e.g., schizophrenia, bipolar affective disorder, alcohol dependence syndrome).
At least 6 months of caregiving experience.
Ability to read and understand the language used in the computer application and group therapy sessions.
Access to a smartphone, tablet, or computer with internet connectivity for participants in the computer application group.
|
|
| ExclusionCriteria |
| Details |
Diagnosed psychiatric disorders in the caregiver that require immediate treatment.
Caregivers currently enrolled in similar psychoeducation or therapy programs.
Individuals with a history of poor adherence to structured interventions.
Conditions that may impair participation in either intervention (e.g., terminal illness, severe mobility issues). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in expressed emotion (EE) levels among caregivers, measured using the Family Attitude Scale (FAS). Assessments will be conducted at baseline, post-intervention (8 weeks). |
At baseline, 8 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes include caregiver burden, quality of life (QoL), adherence. |
Assessments will be conducted at baseline, post-intervention (8 weeks). |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The intervention consists of a comprehensive computer application designed to manage expressed emotions in caretakers of chronic psychiatric patients. It includes modules for psychoeducation, communication skills, emotion regulation, cognitive restructuring, problem-solving, expressed emotion awareness, mindfulness, role-playing, journaling, a resource library, and progress tracking. Family Attitude Scale is used as a questionnaire, it’s a validated measure commonly used to assess family dynamics and attitudes in mental health research. The scale typically includes items related to family cohesion, flexibility, communication patterns, emotional expression, problem-solving abilities, and overall family functioning. Participants rate their agreement or disagreement with each item on a Likert scale, allowing researchers to quantitatively evaluate family attitudes and dynamics. The intervention is compared with traditional group therapy in a Randomized Controlled Trial (RCT) to evaluate its efficacy. |