Management of depression and anxiety among at-risk low-income university students Mental and Behavioural Disorders
Conditions
Interventions
This is a feasibility hybrid type III cluster randomised controlled trial, taking place in four universities in Brazil. Universities will be considered clusters and will be randomly allocated to one o
Sponsors
London School of Economics and Political Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The inclusion criteria for the low-income university students recruited in the pilot cluster RCT are as follows: 1. Currently enrolled at one of the four participating universities 2. Aged between 18 and 30 years 3. Receiving a 100% scholarship from the University for All Programme (PROUNI) [private universities] or a scholarship from the National Student Assistance Plan (PNAES) [public universities] or coming from a family that is or has been a beneficiary of the Bolsa Família Programme
Exclusion criteria
Exclusion criteria: Do not agree to participate in the study by signing the Informed Consent Form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following feasibility outcomes of this pilot study will be measured at 12 weeks, tertiary outcomes measures will be collected at baseline and 12 weeks follow-up and include: 1. Feasibility of data collection will be assessed using the proportion of missing items and distribution of responses on each measure 2. Fidelity of digital mental health intervention delivery by facilitators (all arms) across all sessions (average across intervention arms) based on self-developed instruments designed to assess the implementation of the intervention according to intervention protocols. 3. Reported (severe) adverse events reported during the intervention (average across arms) 4. Safety and feasibility of the two engagement strategies | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcomes will be measured at 12 weeks, tertiary outcomes measures will be collected at baseline and 12 weeks follow-up: Additional implementation measures to help adapt the intervention as needed for a future cRCT will include: 1. Adoption: proportion of students enrolled in the intervention among people who sign up and meet eligibility criteria 2. Acceptability (perceived satisfaction/usefulness of information); Appropriateness (perception that the digital group intervention and implementation strategies are tailored to the needs, culturally appealing and relevant), Utility (perceived benefit of the intervention for improving mental health and well-being), will be assessed using the instrument developed by Weiner et al. (2017). 3. Cost assessment will encompass all expenses associated with implementing i) the intervention, including Zoom platform usage, facilitator training and supervision, time allocated by facilitators to conduct the intervention, including pre-and post-intervention activities (i.e., student contact for enrolment, attendance tracking, and completion of the fidelity questionnaire), and ii) implementation strategies: costs associated with the engagement strategy 1, engagement strategy 2, and combined strategies. Secondary outcome measures for a future cRCT will be: Mental health outcomes: 1. Depressive Symptoms: Patient Health Questionnaire - PHQ-9 2. Anxiety Symptoms: Generalised Anxiety Disorder Scale - GAD-7 Additional measures on engagement: We conceptualise engagement as comprising behavioural, cognitive, and emotional components (Milne-Ives et al., 2024). 1. Behavioural Engagement: 1.1. End of session attendance: Number of sessions attended in the final phase of the programme (i.e., focusing on the last 3 sessions) 1.2. Dropout Rate: Proportion or number of sessions attended before dropout. Dropout will be defined as completing <50% of sessions, missing three consecutive sessions without returning, and without | — |
Countries
Brazil
Contacts
Public ContactSara;Carolina Evans-Lacko;Ziebold
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Outcome results
None listed