ClinicalTrials.gg
Not yet recruitingNCT06474325Updated Sep 16, 2026

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

An interventional study of Intervention via mobile application in Schizophrenia and Schizo Affective Disorder, sponsored by University of Pittsburgh. Not yet recruiting at 1 site in India. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 22 studies in Schizophrenia by University of Pittsburgh — 2 open to participants now, 4 under way, none of them phase 3. Schizophrenia · University of Pittsburgh.

Planned enrollment
14th of 20
44 · median 69
Started
2027
with 1 other
No phase
11 of 22
2 open now
Registered
19th of 22
by date

Among the 22 studies in Schizophrenia by University of Pittsburgh, this one is the 14th largest by planned enrollment of the 20 interventional ones that give a count, is one of 2 that started in 2027, is one of 11 with no phase, and was the 19th registered.

Schizophrenia

3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.

Browse Schizophrenia studies →

Open to participants now

2 of the 22 studies in Schizophrenia by University of Pittsburgh are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

Who these studies take

Of the 331 Schizophrenia studies recruiting now, 63 (19%) set no upper age limit and 257 (78%) stop at 75 or younger; 42 take children under 18; 83 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · no healthy volunteers.

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02

Study 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.

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
  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)
03

Conditions studied

  • Schizophrenia
  • Schizo Affective Disorder

Keywords

  • Schizophrenia
  • Schizo Affective Disorder
  • Adherence
  • Mobile app
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Patients who have active psychotic or mood symptoms.
  2. History of substance use (except nicotine)
  3. Having any serious physical illness. -
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    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

    Behavioral: Intervention via mobile application

Interventions

  • BehavioralIntervention 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and after three months

  2. 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. )

    Time frame: Baseline and after three months

  3. 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

    Time frame: Baseline and after three months

07

Study locations

1 site
  • Government Medical College,
    Palakkad, Kerala, India
    • Nimmy Chandran, MD · Contactdrnimmychandran@gmail.com · 9560372210
    • R.P. Beniwal · Contactbeniwal_09@yahoo.co.in
    • Nimmy Chandran, MD · Principal investigator
    • R.P. Beniwal, MD · Sub investigator
    • Albert Sunny, PhD · Sub investigator
    • Anamika Sahu, PhD · Sub investigator
08

References and documents

Individual participant data

Plan to share: Yes — Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).

Supporting information: Study protocol, Statistical analysis plan

Time frame: One year after publication of this study.

Access criteria: For individual participant data, meta-analysis.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2027; primary completion for May 2028, 11 months later.

Of 753 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's planned 11 months is below that.

Counting every sponsor, half of 766 studies reached it within 32 months; a quarter within 16 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 18, 2024
First posted
Jun 25, 2024
StartEst.
Jun 1, 2027
Primary completionEst.
May 31, 2028
CompletionEst.
Dec 31, 2028
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06474325
Collaborators
Fogarty International Center of the National Institute of Health, Government Medical College, Palakkad-678013
Responsible party
Vishwajit Nimgaonkar, MD PhD (Professor, University of Pittsburgh) — Principal investigator
First posted
Jun 25, 2024
Start date
Jun 1, 2027 (estimated)
Primary completion
May 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Sep 16, 2026

Study contacts

Vishwajit L Nimgaonkar, MD, PhD
Contact
vishwajitnl@upmc.edu
4127265164
Triptish Bhatia, PhD
Contact
trb16@pitt.edu
+919910107210
Vishwajit Nimgaonkar, MD, PhD
principal investigator · University of Pittburgh

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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