NCT06474325

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
12mo left

Started Jun 2026

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
1.9 years until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

December 2, 2025

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

June 18, 2024

Last Update Submit

December 1, 2025

Conditions

SchizophreniaSchizo Affective Disorder

Keywords

SchizophreniaSchizo Affective DisorderAdherenceMobile app

Outcome Measures

Primary Outcomes (3)

  • Feasibility of Mobile app

    To assess the feasibility and the acceptability with a mobile mental health application for medication adherence in persons with SZ and schizoaffective disorder using Acceptability Questionnaire. The scale ranges from 0 to 50.

    Baseline and after three months

  • Acceptibility of Mobile app

    To assess the feasibility and the acceptability with a mobile mental health application for medication adherence in persons with SZ and schizoaffective disorder using Perception of treatment Acceptability scale (Score (0-5) 0= Not at all 5 =very much). Ranges from 0 to 50. )

    Baseline and after three months

  • Adherence to medication

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

    Baseline and after three months

Study Arms (1)

Intervention via mobile app

EXPERIMENTAL

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

Behavioral: Intervention via mobile application

Interventions

Intervention via mobile applicationBEHAVIORAL

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

Intervention via mobile app

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Persons diagnosed with schizophrenia and schizoaffective disorder and are in remission for past two months.
  • Age 18-60 years of any gender.
  • Able to read and understand Malayalam/ English

You may not qualify if:

  • Patients who have active psychotic or mood symptoms.
  • History of substance use (except nicotine)
  • Having any serious physical illness. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Government Medical College,

Palakkad, Kerala, India

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Vishwajit Nimgaonkar, MD, PhD

    University of Pittburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vishwajit L Nimgaonkar, MD, PhD

CONTACT

4127265164vishwajitnl@upmc.edu

Triptish Bhatia, PhD

CONTACT

+919910107210trb16@pitt.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 18, 2024

First Posted

June 25, 2024

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

May 31, 2027

Last Updated

December 2, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
One year after publication of this study.
Access Criteria
For individual participant data, meta-analysis.

Locations

IN(1)