Email-Delivered Digital Positive Affect Intervention for Young Adults in Zimbabwe
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Email-Delivered Positive Affect Intervention, Psychoeducational Control.
- Кому может быть актуально
- Состояния в реестре: Depression Symptoms. Базовые параметры: 18 лет — 25 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Zimbabwe
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
A Brief Email-Delivered Positive Affect Intervention for Young Adults in Zimbabwe: A Feasibility Randomized Controlled Trial
Обзор
This study evaluates the feasibility, acceptability, and preliminary efficacy of a brief email-delivered positive affect intervention for young adults in Zimbabwe. The study uses a randomised controlled trial design with two parallel arms. A total of 100 participants aged 18-25 years will be randomly assigned to two arms: an experimental arm receiving an email-delivered positive affect intervention or a control arm receiving psychoeducational materials. The intervention group will receive guided activities twice weekly over three weeks, focusing on identifying, reflecting on, and engaging in positive experiences. The control group will receive general psychoeducational materials on mental health without structured activities. Assessments will be conducted at baseline and after the intervention. The primary outcome is feasibility( including recruitment, retention, and adherence) and acceptance. Secondary outcomes include changes in positive affect, symptoms of depression and anxiety,self-stigma, and suicidal ideation.
Подробное описание
Digital mental health interventions are increasingly recognised as scalable and accessible approaches to supporting psychological well-being, particularly among young adults. These approaches may be especially valuable in low- and middle-income countries, where mental health services are limited and barriers to help-seeking remain substantial. Previous research in Zimbabwe has demonstrated the feasibility and acceptability of digitally delivered mental health interventions (Dambi et al., 2022). However, little is known about the feasibility of self-guided digital interventions designed to enhance positive affect and psychological well-being among young adults.
Therefore, the aim of this study is to evaluate the feasibility and acceptability of a brief email-delivered positive affect intervention among young adults in Zimbabwe and to explore its preliminary effects on positive affect, negative affect, symptoms of depression and anxiety, suicidality, and self-stigma associated with seeking psychological help.
The primary objective of the study is to evaluate the feasibility, acceptability, usability, and participant engagement of a brief email-based positive affect intervention.
The secondary objectives of the study are; To examine changes in positive affect following participation in the intervention.
To assess changes in anxiety, depression, suicidality, and negative affect following participation in the intervention.
To explore changes in self-stigma associated with seeking psychological help following participation in the intervention.
This study is a two-arm, parallel-group randomised controlled feasibility trial. Participants will be randomly allocated in a 1:1 ratio to either a positive affect intervention group or an active psychoeducational control group. The intervention period will last three weeks, with assessments conducted at baseline (T0) and immediately following the intervention (T1).
In addition to that, participants will be recruited from a previously established cohort of young adults in Zimbabwe who participated in a cross-sectional mental health survey and consented to future contact. The study aims to recruit 100 participants aged 18-25 years.
Ethical approval has been obtained from the Medical Research Council of Zimbabwe and relevant authorities. Participation is voluntary, and informed consent will be obtained before enrolment. Participants may withdraw from the study at any time without penalty. All data will be collected electronically, stored securely, and managed in accordance with data protection and confidentiality requirements.
Вмешательства
- Поведенческое Email-Delivered Positive Affect Intervention
This intervention is a brief email-delivered positive affect program designed specifically for young adults in a low-resource setting and it uses a structured three-step process of remembering, contemplating, and acting on positive experiences to intentionally increase positive affect. Unlike standard psychoeducational or symptom-focused mental health interventions, this program actively guides participants to identify personally meaningful sources of positive emotion and to translate them into - Поведенческое Psychoeducational Control
Participants receive email-based psychoeducational materials about stress, anxiety, depression, and coping strategies over three weeks. No structured behavioural exercises or positive activity tasks are included.
Первичные конечные точки
- Feasibility and Acceptability [Срок оценки: Baseline (Week 0) and post-intervention (Week 3)]
Вторичные конечные точки (5)
- Changes in The Generalized Anxiety Disorder-7 [Срок оценки: Baseline (Week 0) and post-intervention (Week 3)]
- Positive Affect (PANAS Positive Affect Subscale) [Срок оценки: Baseline (Week 0) and post-intervention (Week 3)]
- Changes in The Patient Health Questionnaire-9 [Срок оценки: Baseline (Week 0) and post-intervention (Week 3)]
- Changes in the Self-Stigma (SSOSH) [Срок оценки: Baseline (Week 0) and post-intervention (Week 3)]
- Changes in The SIDAS [Срок оценки: Baseline (Week 0) and post-intervention (Week 3)]
Критерии участия
Критерии включения
Participants must meet all of the following criteria:
- Aged 18-25 years.
- Able to understand and read English.
- Previously participated in Stage 1 of the study and provided consent to be contacted regarding future research opportunities.
- Have access to a device (for example smartphone, tablet, or computer) and internet connectivity for intervention delivery.
- Report moderate levels of depression at baseline assessment.
Критерии исключения
Participants will be excluded if they:
- Are at high risk of suicide.
- Are currently experiencing a psychotic episode.
- Are currently experiencing interpersonal violence.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
Zimbabwe · 1 центр
- University of Zimbabwe Partner Site (Online Recruitment) — Harare
Идентификаторы
NCT: NCT07682779 · MRCZ/A/3394