Management of depression and anxiety symptoms among at-risk low-income university students Mental and Behavioural Disorders
Conditions
Interventions
This is a hybrid type III effectiveness-implementation cluster randomised controlled trial, taking place in 20 universities in Brazil. Universities will be considered as clusters and will be randomly
Sponsors
London School of Economics and Political Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Currently enrolled at one of the 20 participating universities 2. Aged between 18 and 30 years 3. Receiving a 100% scholarship from the University for All Programme (PROUNI) or Universidade Gratuita Programme [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: 1. Do not agree to participate in the study by signing the Informed Consent Form 2. No clinical or behavioral criteria will be applied to exclude participants once enrolled
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Behavioural Engagement measured using study data capturing the number of digital group CBT intervention sessions attended, recoded by Zoom and confirmed by facilitators via REDCap form at one timepoint | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary adoption and engagement outcomes Adoption: Proportion of eligible students who confirm participation before commencement of the first session. Captured via REDCap form at baseline. Cognitive engagement measured using the following: 1. Three-item scale adapted from the Digital Behavior Change Intervention Engagement Scale (DBCI-ES), specifically tailored for this trial, assessing attention and interest with the intervention content adapted from the Digital Behavior Change Engagement Scale, at 3 months 2. Two-item scale assessing sustained cognitive engagement with the intervention, adapted from the DBCI-ES, at 9 months Emotional engagement measured using the following: 1. Three-item scale adapted from the DBCI-ES, specifically tailored for this trial, assessing emotional and experiential responses, such as enjoyment, motivation to apply learned techniques, and sense of connection with the group, at 3 months 2. Three-item scale assessing continued emotional engagement and sustained personal significance of the intervention over time, adapted from the DBCI-ES, at 9 months Behavioural generalisation linking to real-world behaviour change: Three-item scale assessing ongoing application and relevance of intervention-related skills, behaviours, and concepts in participants’ daily lives beyond the active program, adapted from the DBCI-ES, at 3 and 9 months Secondary implementation outcomes assessed at 3 and 9 months: 1. Acceptability, appropriateness and feasibility implementation outcomes measured using the Feasibility of Intervention Measure (FIM) 2. Perceived utility of the intervention measured using a two-item scale about learning helpful strategies in the intervention and their intention to continue using them Secondary mental health outcomes assessed at baseline, 3- and 9-month follow-ups: 1. Depressive symptoms measured using the Patient Health Questionnaire - PHQ-9 2. Anxiety symptoms measured using the Generalised Anxiety Disorder Scale - GAD-7 | — |
Countries
Brazil
Contacts
Public ContactSara;Carolina Evans-Lacko;Ziebold
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Outcome results
None listed