Feasibility and Acceptability of Mobile Mental Health App for SZ and SZA

NCT ID: NCT06474325

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-06-01
• Study Completion Date: 2027-05-31

Brief Summary

A new mental health application will be developed for persons with schizophrenia and schizoaffective disorder. The aim is to look at whether it is feasible to use a mobile health application for improving medication adherence in persons with schizophrenia and schizoaffective disorder and whether it is acceptable to that population.

Detailed Description

Many interventions have been tried to improve the medication adherence of patients with schizophrenia. Individualized interventions using like setting alarms and using checklists have shown significant improvement in compliance with the medications. In the era of mobile applications most of the persons use mobile applications for multiple purposes, which have the potential to influence the life of a person in many ways. A meta-analysis conducted in 2016 showed that 66.4% of psychotic patients owned a mobile phone. A study conducted in North India found that 84.4% of patients with severe mental disorders owned a mobile phone. So if used properly it can also help in improving the life of a person with SZ.

Many mobile applications have been used to improve medication compliance in general. But only a few mobile applications have specifically focused the persons with schizophrenia. Very few studies have investigated the efficacy of mobile applications to improve medication adherence in patients with schizophrenia. This study will be assessing the feasibility of developing a mobile application and using the application for improving compliance of medications in persons with schizophrenia and schizoaffective disorder.

Primary aims:

• To develop a mobile mental health application for the improvement of medication adherence in persons with schizophrenia and schizoaffective disorder
• To assess the feasibility and the acceptability of using a mobile mental health application for improving the medication adherence of persons with schizophrenia and schizoaffective disorder

Primary Objectives:

• To assess the feasibility and the acceptability of using a mobile mental health application for improving the medication adherence of persons with schizophrenia and schizoaffective disorder

Secondary Objective:

• To compare the Medication adherence rating scale scores before and after using mental health application for improving medication adherence in persons with schizophrenia and schizoaffective disorder

1. Initial screening of the participants will be done by the psychiatrist( PI)( In the Psychiatry OPD )

2. Persons with schizophrenia and schizoaffective disorder who are in remission(In Remission for past 2 months) and attending the Psychiatry Outpatient department at Government Medical College, Palakkad will be recruited

3. After taking informed consent participants will be assigned into intervention group

4. Pre intervention assessments will be done ((e.g., Symptoms, the Medication Adherence using relevant scales)

5. After the pre-intervention assessment, Mobile application will be installed into participants mobile phone(Instruction will be given on the features of the mobile application and how to use it )

6. Participants will receive the intervention via mobile application installed to their mobile phone (patient will continue to take their regular medications including antipsychotics. Intervention via mobile application include psychoeducational videos, reminders, and virtual rewards and badges for completing the challenges to encourage adherence of medications)

7. Duration of intervention will be three months

8. Post-intervention assessment will be done within one week after completion of the intervention (e.g., symptoms, the Medication Adherence, feedback (Acceptance questionnaire)

Conditions

Schizophrenia; Schizo Affective Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention via mobile app

Intervention via mobile application include psychoeducational videos, reminders, and virtual rewards and badges for completing the challenges to encourage adherence of medications

Group Type: EXPERIMENTAL

Intervention via mobile application

Intervention Type: BEHAVIORAL

Intervention via mobile application include psychoeducational videos, reminders, and virtual rewards and badges for completing the challenges to encourage adherence of medications

Interventions

Intervention via mobile application

Intervention via mobile application include psychoeducational videos, reminders, and virtual rewards and badges for completing the challenges to encourage adherence of medications

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Persons diagnosed with schizophrenia and schizoaffective disorder and are in remission for past two months.

2. Age 18-60 years of any gender.

3. Able to read and understand Malayalam/ English

Exclusion Criteria

1. Patients who have active psychotic or mood symptoms.

2. History of substance use (except nicotine)

3. Having any serious physical illness. -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role: collaborator

Government Medical College, Palakkad-678013

UNKNOWN

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Vishwajit Nimgaonkar, MD PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vishwajit Nimgaonkar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittburgh

Locations

Government Medical College,

Palakkad, Kerala, India

Countries

India

Central Contacts

Vishwajit L Nimgaonkar, MD, PhD

Role: CONTACT

vishwajitnl@upmc.edu

4127265164

Triptish Bhatia, PhD

Role: CONTACT

trb16@pitt.edu

+919910107210

Facility Contacts

Nimmy Chandran, MD

Role: primary

drnimmychandran@gmail.com

9560372210

R.P. Beniwal

Role: backup

beniwal_09@yahoo.co.in

Other Identifiers

STUDY23090042

Identifier Type: -

Identifier Source: org_study_id

D43TW009114

Identifier Type: NIH

Identifier Source: secondary_id

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