SchizophreniaNCT06474325
Feasibility and Acceptability of Mobile Mental Health App for SZ and SZA
A study testing Intervention via mobile application in people with Schizophrenia and Schizo Affective Disorder, run by University of Pittsburgh at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Schizo Affective Disorder
- What is being tested?
- Intervention via mobile application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jun 2027to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Patients who have active psychotic or mood symptoms.
- History of substance use (except nicotine)
- Having any serious physical illness. -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Government Medical College,
Palakkad, Kerala
Nimmy Chandran, MD, 9560372210, drnimmychandran@gmail.com
R.P. Beniwal, beniwal_09@yahoo.co.in
About this study
Official title: Feasibility and Acceptability of Mobile Mental Health Application for the Improvement of Medication Adherence in Persons With Schizophrenia(SZ) and Schizoaffective Disorder(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.
Read the 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
- 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)
- Conditions
- Schizophrenia, Schizo Affective Disorder
- Being tested
- Intervention via mobile application
- Keywords
- Schizophrenia, Schizo Affective Disorder, Adherence, Mobile app
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention via mobile applicationBehavioural
Intervention via mobile application include psychoeducational videos, reminders, and virtual rewards and badges for completing the challenges to encourage adherence of medications
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Intervention via mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
)
Measured: 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
Measured: Baseline and after three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Jun 2027 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, Government Medical College, Palakkad-678013
- Responsible party
- Principal investigator, Vishwajit Nimgaonkar, MD PhD, University of Pittsburgh
- Investigators
- Vishwajit Nimgaonkar, MD, PhD, Principal investigator, University of Pittburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474325
- Sponsor's protocol ID
- STUDY23090042
- Other IDs
- D43TW009114
- Status last verified
- Sep 2026
- First submitted
- 18 Jun 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).