Clinical trial NCT06474325: Feasibility and Acceptability of Mobile Mental Health App for SZ and SZA
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Schizophrenia
Schizo Affective Disorder
Keywords: Schizophrenia
Schizo Affective Disorder
Adherence
Mobile app
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
name: Government Medical College, Palakkad-678013
First posted: 2024-06-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: SUPPORTIVE_CARE

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)

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. -

Primary outcomes:
measure: Feasibility of Mobile app
timeFrame: Baseline and after three months
measure: Acceptibility of Mobile app
timeFrame: Baseline and after three months
measure: Adherence to medication
timeFrame: Baseline and after three months
Secondary outcomes:
Other outcomes:
Locations:
city: Palakkad
country: India
facility: Government Medical College,
state: Kerala
Study officials:
affiliation: University of Pittburgh
name: Vishwajit Nimgaonkar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: