Clinical trial NCT06320756: Examining the Feasibility of Wysa in Hindi
Official title: A Feasibility Study of a Digital Mental Health Intervention (Wysa in Hindi) in Improving Mental Health Distress in Adolescents and Young Adults with Type 1 Diabetes in Low Resource Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Issue
Diabetes Distress
Keywords: digital mental health
Lead sponsor: Wysa
Sponsor class: INDUSTRY
Collaborators: name: Udaan
First posted: 2024-03-20
Enrollment: 79
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial with an intervention arm and a control arm.
Primary purpose: OTHER

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility - Recruitment rate (Proportion of participants who completed consent procedures)
timeFrame: Measured at the end of the recruitment period (3 weeks, or if recruitment is extended at the end of 2 months)
measure: Feasibility - Retention rate (Proportion of participants who remained enrolled within the study for the entire study duration)
timeFrame: Measured after the 2 month intervention during follow-up endline assessments
measure: Feasibility - Wysa Engagement (Proportion of recruited participants who engaged in at least 1 interaction with the Wysa app)
timeFrame: Measured at the end of the 2 month intervention
measure: Feasibility - App therapist engagement rate (Proportion of recruited participants who completed at least one therapist session within the Wysa app)
timeFrame: Measured at the end of the 2 month intervention
measure: Satisfaction with the app which is collected through 3 quantitative questions and 1 free text qualitative question on the app
timeFrame: This is collected twice; on day 2 and day 45 from onboarding on the app
measure: Therapist Satisfaction feedback collected through 3 quantitative questions and 1 free text qualitative question on the app
timeFrame: Collected post every therapist session during the intervention period of 2 months
Secondary outcomes:
measure: Change in mental health distress as measured by the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline assessment, and then at the 2 month follow-up endline assessment
measure: Change in mental health distress as measured by the Diabetes Distress Scale (DDS-17)
timeFrame: Baseline assessment, and then at the 2 month follow up assessment
Other outcomes:
Locations:
city: Aurangabad
country: India
facility: Udaan
state: Maharashtra
Study officials:
affiliation: Touchkin eServices Pvt. Ltd.
name: Tejaswi Shetty, M.A.
role: PRINCIPAL_INVESTIGATOR
affiliation: Udaan
name: Archana Sarda, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Touchkin eServices Pvt. Ltd.
name: Chaitali Sinha, M.A.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
citation: Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. doi: 10.2337/diacare.28.3.626.