Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Heidelberg Institute of Global Health HIGH University Clinic Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Voluntary enrollment into the study (written consent) • Fulfillment of criteria for increased psychological distress or early symptoms of emotional dysregulation, that is • Difficulties in emotion regulation assessed with the DERS-SF • None of the participants fulfills the criteria for a severe mental illness (including psychosis, severe major depression, severe anxiety disorder, mania or hypomania, severe borderline personality disorder), measured with established measures.
Exclusion criteria
Exclusion criteria: • Persons with a severe mental or physical illness that impedes the use of the training (i.e., mental disorder of stage 2 or above; severe physical disability like total blindness) • Current suicidal ideation, assessed with the Community Quick Screening Tool (QST) and a mental health professional • Consumption of alcohol or other psychotropic substances on the day of the assessment (self-report, QST) • Evidence that symptoms of psychological distress are precipitated by an organic disease, i.e. epilepsy, brain tumor, or other significant neurological diseases • Insufficient command of the local language (i.e., English or Swahili) • Participants refusing or withdrawing informed assent or consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Emotion regulation difficulties at post-intervention, assessed using the short form of the Difficulties in Emotion Regulation Scale (DERS-SF, 18-item self-report, 6 subscales, rated on a Likert scale from 1–5). Primary analysis will compare total sum scores between the blended intervention and the control condition. Time Frame: Baseline to post-intervention comparison (4-6 weeks after baseline) | — |
Secondary
| Measure | Time frame |
|---|---|
| Momentary data will be collected 6 times per day (4 random EMA prompts, 1 morning, 1 evening) throughout the 28-day intervention. Outcomes include momentary affect, event-related stress, stress reactivity, emotion regulation, and social context. Affect is assessed with bipolar items and emotion facets; stress reactivity is calculated based on affect-stress associations. Emotion regulation is measured using a 4-item short version of the State Difficulties in Emotion Regulation Scale (S-DERS) and two additional perceived emotion regulation capacity items. All items are rated on a 0–100 visual analogue scale.;Secondary outcomes at post-intervention include positive and negative affect (Positive and Negative Affect Schedule), symptoms of depression, anxiety, and stress (Depression Anxiety Stress Scale – 21 item version), emotional reactivity (Perth Emotional Reactivity Scale – short form), emotion beliefs (Emotion Beliefs Questionnaire), emotion regulation strategies (Emotion Regulation Questionnaire), and interpersonal emotion regulation (Interpersonal Emotion Regulation Questionnaire). Average or sum scores per scale/subscale will be used for analysis. DERS-SF subscale scores will also be analyzed as secondary outcomes.;Process evaluation. Implementation outcomes include reach, fidelity, dose, adherence, and participant engagement. Data sources include attendance logs, app use data, session observations, facilitator surveys, and interviews with adolescents and lay providers. Fidelity is assessed through independent ratings and provider feedback. Engagement is explored through surveys, in-depth interviews, and focus group discussions.;Acceptability, usability, and safety: Acceptability and usability are assessed post-intervention using validated questionnaires, e.g. the mHealth App Usability Questionnaire (MAUQ). About 30 participants will provide qualitative feedback in interviews. Safety is monitored through documentation and reporting of serious adverse events (SAE | — |
Countries
Kenya
Contacts
Public ContactTom Osborn
CEO of Shamiri
Outcome results
None listed