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NCT Number: NCT06474325

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Government Medical College,

Palakkad, Kerala, India

Location contact

Albert Sunny, PhD

SUB_INVESTIGATOR

Anamika Sahu, PhD

SUB_INVESTIGATOR

Nimmy Chandran, MD

CONTACT

[email protected]

9560372210

Nimmy Chandran, MD

PRINCIPAL_INVESTIGATOR

R.P. Beniwal

CONTACT

[email protected]

R.P. Beniwal, MD

SUB_INVESTIGATOR

About this study

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
  • Initial screening of the participants will be done by the psychiatrist( PI)( In the Psychiatry OPD )
  • 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
  • After taking informed consent participants will be assigned into intervention group
  • Pre intervention assessments will be done ((e.g., Symptoms, the Medication Adherence using relevant scales)
  • 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 )
  • 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)
  • Duration of intervention will be three months
  • Post-intervention assessment will be done within one week after completion of the intervention (e.g., symptoms, the Medication Adherence, feedback (Acceptance questionnaire)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Intervention via mobile application

Behavioral

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

Primary outcomes

  1. Feasibility of Mobile app

    Time frame: Baseline and after three months

    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.

  2. Acceptibility of Mobile app

    Time frame: Baseline and after three months

    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.

    )

  3. Adherence to medication

    Time frame: Baseline and after three months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Triptish Bhatia, PhD

CONTACT

[email protected]

+919910107210

Vishwajit L Nimgaonkar, MD, PhD

CONTACT

[email protected]

4127265164

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Fogarty International Center of the National Institute of Health
  • Government Medical College, Palakkad-678013

Registry information

Official study title

Feasibility and Acceptability of Mobile Mental Health Application for the Improvement of Medication Adherence in Persons With Schizophrenia(SZ) and Schizoaffective Disorder(SZA)

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 25, 2024
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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