Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: ? Adolescent males or females aged between 15 and 19 years in grades 9 to 11 at the beginning of the study ? Mild to moderately severe depression indicated by a score between 5 and 19 on the PHQ-A. Those with mild depression (PHQA score 5-9) will only be included if both screening and baseline PHQA scores are more than/ equal to 5 ? Able to read sufficiently in Xitsonga to use the app ? Participant (and their parent/ guardian if <18) is willing and able to give informed consent and/or assent for participation in the trial ? Participant is intending to continue to live in the study area for 12 weeks after baseline
Exclusion criteria
Exclusion criteria: ? Hospitalisation for at least five days for severe psychiatric illness (specifically bipolar disorder, schizophrenia and other psychoses), or a life-threatening or other serious physical illness ? History of bipolar disorder, schizophrenia and other psychoses ? Severe depression as indicated by score >19 on the PHQ-A and assessed by Trial Psychologist as too severe to participate ? Current suicidal ideation/thoughts with specific plans and means identified ? Currently receiving a psychological treatment for a mental health problem(s) ? Lacks capacity to consent to treatment or research participation ? Lacks capacity to utilise the app whether recruited to control or treatment group ? Any other reason that the staff feel would jeopardize the health or well-being of the participant or staff or would prevent proper conduct of the study ? Adolescents who do not speak Xitsonga
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility and acceptability of the digitally delivered Behavioural Activation (BA) therapy intervention to overcome depression. We will assess the number of participants: recruited, assessed at baseline, randomised, completing the course of treatment, completing follow up measures. We will assess the acceptability of the recruitment method (including acceptability of randomisation), intervention and study design through a series of in-depth interviews and an Acceptability Questionnaire with participants. ;Initial efficacy of the intervention on depressive symptoms amongst adolescents with depression compared to control. Depression symptoms will be assessed on the 9-item Patient Health Questionnaire Adolescent version 9-item (PHQ-A) | — |
Secondary
| Measure | Time frame |
|---|---|
| To pilot locally adapted outcome measures of mental health to inform the development of a further larger trial. - Generalised Anxiety Disorder (GAD-7) - Conor-Davidson Resilience Scale 10-item (CD-RISC) - Brief Rumination Response Scale 5-item (RRS) - Behavioural Activation for Depression Scale 25-item (BADS) - Emotional wellbeing (WEMWBS) ;To pilot locally adapted outcome measures of cognition and collect descriptive data to inform the development of a further larger trial. Cognition tasks: - Affective set-shifting task - Affective go/no-go task - Affective backwards digit span - Balloon Analogue Risk Task (BART) - Matrix Reasoning Item Bank (MaRs-IB) - Emotion recognition task;To pilot locally adapted outcome measures of risky behaviours and collect descriptive data to inform the development of a further larger trial. Risky Behaviours - School attendance - Substance use - Sexual behaviour Peer Influence scales;To pilot locally adapted socioeconomic measures and collect descriptive data to inform the development of a further larger trial. Socio-economic measures: - Employment and earnings - Consumption and finances - Aspirations and expectations - Time preference, risk preference, and loss aversion task | — |
Countries
South Africa
Contacts
Professor of Public Health