Email-Delivered Digital Positive Affect Intervention for Young Adults in Zimbabwe (SPARK-Z)
A Brief Email-Delivered Positive Affect Intervention for Young Adults in Zimbabwe: A Feasibility Randomized Controlled Trial
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.
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Fadzai Munyuki, MSc
- Telefonszám: +370 63094505
- E-mail: fadzai.munyuki@fsf.stud.vu.lt
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Evaldas Kazlauskas, PhD
- E-mail: evaldas.kazlauskas@fsf.vu.lt
Tanulmányi helyek
-
-
Harare
-
Harare, Harare, Zimbabwe, 00000
- University of Zimbabwe Partner Site (Online Recruitment)
-
Kapcsolatba lépni:
- Samson Mhizha, PhD
- Telefonszám: +263774123215
- E-mail: smmhizha30@gmail.com
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
Egészséges önkénteseket fogad
Leírás
Inclusion Criteria
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.
Exclusion Criteria
Participants will be excluded if they:
- Are at high risk of suicide.
- Are currently experiencing a psychotic episode.
- Are currently experiencing interpersonal violence.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Megelőzés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Aktív összehasonlító: Psychoeducational Control
Intervention type: Behavioral Intervention (Psychoeducation) Participants receive email-based psychoeducational materials at one point. The materials provide structured information on mental health and emotional well-being, including stress, anxiety, depression, and coping strategies. Participants are encouraged to read and reflect on the information during the study period. The control condition does not include structured behavioural exercises or positive activity tasks. |
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.
|
|
Kísérleti: Email-Delivered Positive Affect Intervention
Participants allocated to the intervention group will receive a brief, structured, email-delivered positive affect intervention over a three-week period. Emails will be delivered twice weekly and will include psychoeducational content, guided reflection exercises, and activities designed to increase awareness of positive experiences and promote engagement in meaningful daily activities. The intervention is organised into three sequential phases:
Across these phases, participants will identify personally meaningful sources of positive emotion, reflect on their relevance and feasibility within everyday life, and engage in positive activities aimed at enhancing positive affect and psychological well-being. |
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 daily behavioural activities. The intervention is fully automated and delivered entirely via email, making it highly scalable and accessible without the need for trained clinicians or face-to-face contact.
Más nevek:
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Feasibility and Acceptability
Időkeret: Baseline (Week 0) and post-intervention (Week 3)
|
Feasibility , usability and acceptability will be assessed using self-reported participation in email activities.
Participant feedback on usability, satisfaction, and acceptability of the program will be collected at the post-intervention assessment using self-report questions.
|
Baseline (Week 0) and post-intervention (Week 3)
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Changes in The Generalized Anxiety Disorder-7
Időkeret: Baseline (Week 0) and post-intervention (Week 3)
|
Changes in symptoms of anxiety are measured.
The Generalized Anxiety Disorder-7 (GAD-7, Spitzer et al., 2006) is a self-report measure comprising 7 items about symptoms of anxiety.
All items are answered on a 4-point Likert scale that ranges from 0 (not at all) to 3 (nearly every day).
A higher score indicates more pronounced symptoms.
|
Baseline (Week 0) and post-intervention (Week 3)
|
|
Positive Affect (PANAS Positive Affect Subscale)
Időkeret: Baseline (Week 0) and post-intervention (Week 3)
|
Changes in positive affect are measured using the Positive and Negative Affect Schedule (PANAS; Watson et al., 1988) positive affect subscale.
The PANAS is a self-report measure comprising 20 items, with 10 items assessing positive affect and 10 items assessing negative affect.
Items are rated on a 5-point Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely).
A higher score on the positive affect subscale indicates greater frequency of positive emotional experiences.
|
Baseline (Week 0) and post-intervention (Week 3)
|
|
Changes in The Patient Health Questionnaire-9
Időkeret: Baseline (Week 0) and post-intervention (Week 3)
|
Changes in symptoms of depression are measured.
The Patient Health Questionnaire-9 (PHQ-9, Kroenke et al., 2001) is a self-report measure comprising 9 items about symptoms of depression.
All items are answered on a 4-point Likert scale that ranges from 0 (not at all) to 3 (nearly every day).
A higher score indicates more pronounced symptoms.
|
Baseline (Week 0) and post-intervention (Week 3)
|
|
Changes in the Self-Stigma (SSOSH)
Időkeret: Baseline (Week 0) and post-intervention (Week 3)
|
Changes in self-stigma associated with seeking psychological help are measured using the Self-Stigma of Seeking Help Scale (SSOSH; Vogel et al., 2006).
The SSOSH is a self-report measure comprising 10 items assessing negative beliefs and attitudes about seeking professional psychological help.
All items are answered on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).
A higher score indicates greater self-stigma associated with seeking psychological help.
|
Baseline (Week 0) and post-intervention (Week 3)
|
|
Changes in The SIDAS
Időkeret: Baseline (Week 0) and post-intervention (Week 3)
|
Changes in suicidal ideation are measured.
The SIDAS (Van Spijker et al., 2014) is a self-report measure comprising 5 questions about suicidal ideation.
All items are answered on a 10-point Likert scale that ranges from 0 (never, no control, not close at all, not at all) to 10 (always, full control, made an attempt, extremely).
A higher score indicates more pronounced symptoms.
|
Baseline (Week 0) and post-intervention (Week 3)
|
Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Evaldas Kazlauskas, PhD, Vilnius University
- Kutatásvezető: Samson Mhizha, PhD, University of Zimbabwe
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- MRCZ/A/3394
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
IPD megosztási időkeret
Start Date:
After publication of the primary study results
End Date:
Until 5 years after study completion
IPD-megosztási hozzáférési feltételek
De-identified individual participant data (IPD) and supporting study materials will be available to qualified researchers upon reasonable request. Access will be granted to researchers who provide a methodologically sound proposal and agree to use the data only for approved research purposes.
Researchers may request access to de-identified participant-level data, including baseline and post-intervention questionnaire responses (e.g., PHQ-9, GAD-7, PANAS, SSOSH, SIDAS) and relevant demographic variables. Supporting materials such as the study protocol, statistical analysis plan, and data dictionary may also be shared.
Data access requests will be reviewed and approved by the principal investigator in accordance with ethical approvals from the Medical Research Council of Zimbabwe (MRCZ) and relevant oversight from the Ministry of Health and Child Care of Zimbabwe. Once approved, data will be shared securely via encrypted file transfer or password-protected data-sharing platforms.
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
- NEDV
- ICF
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .