NCT07682779

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
24mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Jul 2026Aug 2028

First Submitted

Initial submission to the registry

June 26, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

July 6, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

June 26, 2026

Last Update Submit

June 26, 2026

Conditions

Keywords

Positive affectInterventionDigital interventionYoung adultsMental health outcomesFeasibilityZimbabweRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Feasibility and Acceptability

    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)

Secondary Outcomes (5)

  • Changes in The Generalized Anxiety Disorder-7

    Baseline (Week 0) and post-intervention (Week 3)

  • Positive Affect (PANAS Positive Affect Subscale)

    Baseline (Week 0) and post-intervention (Week 3)

  • Changes in The Patient Health Questionnaire-9

    Baseline (Week 0) and post-intervention (Week 3)

  • Changes in the Self-Stigma (SSOSH)

    Baseline (Week 0) and post-intervention (Week 3)

  • Changes in The SIDAS

    Baseline (Week 0) and post-intervention (Week 3)

Study Arms (2)

Psychoeducational Control

ACTIVE COMPARATOR

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.

Behavioral: Psychoeducational Control

Email-Delivered Positive Affect Intervention

EXPERIMENTAL

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: * Week 1: Remember * Week 2: Contemplate * Week 3: Act 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.

Behavioral: Email-Delivered Positive Affect Intervention

Interventions

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.

Also known as: SPARK-Z
Email-Delivered Positive Affect Intervention

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.

Psychoeducational Control

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Participants will be excluded if they:
  • Are at high risk of suicide.
  • Are currently experiencing a psychotic episode.
  • Are currently experiencing interpersonal violence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zimbabwe Partner Site (Online Recruitment)

Harare, Harare, 00000, Zimbabwe

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Evaldas Kazlauskas, PhD

    Vilnius University

    PRINCIPAL INVESTIGATOR
  • Samson Mhizha, PhD

    University of Zimbabwe

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Evaldas Kazlauskas, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No additional parties are masked in this study.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants are randomized in equal proportions to either a three-week email-delivered positive affect intervention or a psychoeducational control condition. The study uses a between-subjects design, with outcomes assessed at baseline and post-intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 26, 2026

First Posted

July 6, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

July 6, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) will be shared upon reasonable request from qualified researchers. Data that may be shared include baseline and post-intervention questionnaire responses (e.g., PHQ-9, GAD-7, PANAS, SSOSH, SIDAS) and relevant demographic variables. All data will be fully anonymised before sharing to ensure participant anonymity. Requests will be reviewed by the study team and approved if they align with ethical approvals and data protection requirements. Data will be made available after publication of primary study results.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Start Date: After publication of the primary study results End Date: Until 5 years after study completion
Access Criteria
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.

Locations