Examining the Feasibility of Wysa in Hindi

Wysa

Status: Completed

Conditions: Mental Health Issue; Diabetes Distress

Treatments: Behavioral: Individual and group sessions on topics like motivation, coping, wellbeing; Behavioral: Wysa in Hindi

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06320756

24-WYSA-101

Details and patient eligibility

About

The principal objective of this study is to investigate the feasibility of including a digital mental health intervention (Wysa in Hindi) within pre-existing usual care to support adolescents and young adults with Type 1 Diabetes (T1D) who have mild and above mental health distress (operationalized as Patient Health Questionnaire-9: 5-14 scores; or Diabetes Distress Scale-17: >2.0 mean score) with their mental health distress. This will be conducted through an exploratory randomized control study comparing Wysa in Hindi plus usual care with a control arm that just has usual care. The study further explores the effectiveness of the digital mental health intervention using the Patient Health Questionnaire (PHQ-9) and Diabetes Distress Scale (DDS-17).

Full description

Participants (13-25 years) with Type1 Diabetes are invited into the study. The intervention being studied is the Wysa in Hindi app. Participants will be recruited from Udaan (a Non-Governmental Organization (NGO) supporting individuals with Type1 diabetes). They will complete baseline research procedures and be randomly allocated to one of two groups.

Participants in the intervention arm will get access to the Wysa in Hindi app as well as access to usual care (individual and group sessions on motivation, mental health, and coping). The control arm will only have access to the usual care i.e. the individual and group sessions. At the end of 2 months, participants will be invited for follow-up to complete the endline assessments.

Enrollment: 79 patients

Sex: All

Ages: 13 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 13-25 years
• Diagnosis of Type1 diabetes
• Access to a smartphone with internet connection
• Can read and understand Hindi
• Mental health distress as demonstrated by elevated scores on any of the scales: Mild -moderate symptoms (between 5-14 score) on Patient Health Questionnaire (PHQ-9), moderate and above diabetes distress (mean score 2.0 and higher) on the Diabetes Distress Scale (DDS-17)

Exclusion criteria

• Do not own or have access to a mobile device
• Are identified to have risk of harm/ suicidality (as identified on PHQ-9)
• Are currently undergoing or have received psychiatric support
• Experience any mental or physical impairments that create accessibility barriers to the use of a smartphone or access to a digital mental health intervention

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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79 participants in 2 patient groups

Intervention arm: Wysa in Hindi + usual care

Experimental group

Description:

The intervention arm will receive Wysa in Hindi and the usual care. Wysa in Hindi is a digital mental health intervention that combines Artificial Intelligence-led conversational chatbot support and human therapy in the Hindi language. The Artificial Intelligence (AI) chatbot acts as a companion, and understands, empathizes, and guides users through exercises grounded in cognitive behavioral therapy (CBT) techniques, written by qualified psychologists and clinicians. Usual care includes access to individual and bi-weekly group sessions focused on building coping, wellbeing, and motivation by the diabetes educator team.

Treatment:

Behavioral: Wysa in Hindi

Behavioral: Individual and group sessions on topics like motivation, coping, wellbeing

Usual care arm

Active Comparator group

Description:

Participants in the control group will only have access to usual care (which will remain the same as that for the intervention arm). This includes access to individual sessions and bi-weekly group sessions with the diabetes education team on motivation, wellbeing, and coping.

Treatment:

Behavioral: Individual and group sessions on topics like motivation, coping, wellbeing