Depression SymptomsSPARK-ZNCT07682779
Email-Delivered Digital Positive Affect Intervention for Young Adults in Zimbabwe
A study testing Email-Delivered Positive Affect Intervention in people with Depression Symptoms, run by Vilnius University at 1 site in Zimbabwe.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Depression Symptoms
- What is being tested?
- Email-Delivered Positive Affect Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteZimbabwe
- Study dates
- 1 Jul 2026to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Participants will be excluded if they:
- Are at high risk of suicide.
- Are currently experiencing a psychotic episode.
- Are currently experiencing interpersonal violence.
Trial locations and contacts
1 site in 1 country.
Zimbabwe1 site
University of Zimbabwe Partner Site (Online Recruitment)
Harare, Harare, 00000
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Depression Symptoms
- Being tested
- Email-Delivered Positive Affect Intervention, Psychoeducational Control
- Keywords
- Positive affect, Intervention, Digital intervention, Young adults, Mental health outcomes, Feasibility, Zimbabwe, Randomized controlled trial
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Email-Delivered Positive Affect InterventionBehavioural
Also called SPARK-Z
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.
Psychoeducational ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Email-Delivered Positive Affect Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0) and post-intervention (Week 3)
Secondary outcomes (5)
Changes in The Generalized Anxiety Disorder-7
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.
Measured: Baseline (Week 0) and post-intervention (Week 3)
Positive Affect (PANAS Positive Affect Subscale)
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.
Measured: Baseline (Week 0) and post-intervention (Week 3)
Changes in The Patient Health Questionnaire-9
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.
Measured: Baseline (Week 0) and post-intervention (Week 3)
Changes in the Self-Stigma (SSOSH)
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.
Measured: Baseline (Week 0) and post-intervention (Week 3)
Changes in The SIDAS
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.
Measured: Baseline (Week 0) and post-intervention (Week 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Jul 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zimbabwe
- Responsible party
- Principal investigator, Evaldas Kazlauskas, Vilnius University
- Investigators
- Evaldas Kazlauskas, PhD, Principal investigator, Vilnius UniversitySamson Mhizha, PhD, Principal investigator, University of Zimbabwe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682779
- Sponsor's protocol ID
- MRCZ/A/3394
- Acronym
- SPARK-Z
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Email-Delivered Positive Affect Intervention for Young Adults in Zimbabwe: A Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07682779
- Acronym / sponsor ID
- SPARK-Z / MRCZ/A/3394
- Conditions
- Depression Symptoms
- Keywords
- Positive affect, Intervention, Digital intervention, Young adults, Mental health outcomes, Feasibility, Zimbabwe, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Collaborators
- University of Zimbabwe
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Psychoeducational Control | Active comparator | Behavioral: Psychoeducational ControlIntervention 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. |
| Email-Delivered Positive Affect Intervention | Experimental | Behavioral: Email-Delivered Positive Affect InterventionParticipants 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- Are at high risk of suicide.
- Are currently experiencing a psychotic episode.
- Are currently experiencing interpersonal violence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Email-Delivered Positive Affect InterventionAlso: SPARK-ZThis 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. | Behavioural | Email-Delivered Positive Affect Intervention |
| Psychoeducational ControlParticipants 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. | Behavioural | Psychoeducational Control |
Primary outcome
Feasibility and Acceptability
Time frame: 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.
5 secondary outcomes
Changes in The Generalized Anxiety Disorder-7
Time frame: Baseline (Week 0) and post-intervention (Week 3)
Positive Affect (PANAS Positive Affect Subscale)
Time frame: Baseline (Week 0) and post-intervention (Week 3)
Changes in The Patient Health Questionnaire-9
Time frame: Baseline (Week 0) and post-intervention (Week 3)
Changes in the Self-Stigma (SSOSH)
Time frame: Baseline (Week 0) and post-intervention (Week 3)
Changes in The SIDAS
Time frame: Baseline (Week 0) and post-intervention (Week 3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evaldas Kazlauskas, PhD principal investigator
Vilnius University
Samson Mhizha, PhD principal investigator
University of Zimbabwe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Email-Delivered Positive Affect Intervention in people with Depression Symptoms, run by Vilnius University at 1 site in Zimbabwe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Acceptability (time frame: Baseline (Week 0) and post-intervention (Week 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.