Internet-based InterventionNCT07030244
Treatment Outcomes and Predictive Factors of the Effectiveness and Adherence of Moodpep: an Online Self-help Intervention for College Students With Depressive Symptoms
A study testing Moodpep in people with Internet-based Intervention and Depression, run by Universiteit Leiden at 2 sites in Netherlands.
Trial summary
Depressive symptoms are prevalent among college students and often remain untreated. E-health interventions may help overcome treatment barriers by offering accessible and flexible support. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Internet-based Intervention, Depression, Adherence
- What is being tested?
- Moodpep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Jun 2020to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Eligible for Moodpep were students from the participating universities and universities of applied sciences: VU Amsterdam, Leiden University, Maastricht University, Utrecht University, Erasmus University Rotterdam, University of Amsterdam, InHolland University of Applied Sciences, Avans University of Applied Sciences and Rotterdam University of Applied Sciences.
The following inclusion criteria for Moodpep were used:
- age 16 or older;
- informed consent was provided;
- reading Dutch and/or English fluently;
- having access to a device with internet (e.g., computer, laptop);
- providing complete data at baseline; and
- no severe depressive symptoms (PHQ-9 total score > 20) or risk of suicidal behavior (based on 3 questions).
This last criterion was removed on May 9, 2023. After data collection, for statistical and content-related reasons, PhD students were removed from the analysis, just as students below 18 and above 30 years old, students who indicated their gender was other and students who completed less than 1 module of the intervention. This was done because the focus of the study was on students and not PhD students who are employees in the Netherlands, most students are between 18 and 30 years old, not enough students of another gender participated to include them separately in the analyses, and we were interested in the effects of Moodpep for students who started the intervention.
Trial locations and contacts
2 sites in 1 country.
About this study
Depressive symptoms are prevalent among college students and often remain untreated. E-health interventions may help overcome treatment barriers by offering accessible and flexible support. This study will evaluate the effects of Moodpep, a guided online intervention for college students with depressive symptoms, and will examine predictors of treatment success and adherence.
- Conditions
- Internet-based Intervention, Depression, Adherence, Predictors, Students, Effectiveness
- Being tested
- Moodpep
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoodpepBehavioural
See arm description
| Study group | Role | What they receive |
|---|---|---|
| Moodpep | Experimental | Moodpep is an online self-help intervention to reduce depressive symptoms in college students (Garnefski \& Kraaij, 2023). The intervention is based on CBT and consists of four main components in eight modules: behavioral activation, relaxation, changing negative cognitions and goal attainment. Students were advised to work on the intervention for one to two hours each week for about six to eight weeks.
During the intervention, students received coaching via text messages on the platform. Coaches are trained Master's students in clinical psychology and they provided feedback on the assignments that students completed and motivated students to continue the intervention. Receives: Behavioral: Moodpep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms (PHQ-9)
Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001). Total scores range from 0 to 27 with higher scores indicating more depressive symptoms.
Measured: T0 (baseline), T1 (6 weeks post-baseline), T2 (6 months post-baseline)
Secondary outcomes (2)
Adherence
Number of modules completed (1-8). For the logistic regression analysis, 2 categories will be made: participants who completed 1 module and participants who completed 2-8 modules.
Measured: T1 (6 weeks post-baseline)
Predictors
Age, gender (male, female), nationality (Dutch, international), current psychotropic medication use (yes, no), and current psychotherapy (yes, no).
Measured: T0 (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Jun 2020
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internet-based InterventionStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All students will start with Moodpep: a guided online self-help intervention for college students with depressive symptoms.
- Masking
- None (open label)
- Enrolment
- 1,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Leiden
- Sponsor type
- University, hospital or other
- Collaborators
- VU University of Amsterdam, Maastricht University, Utrecht University, University of Amsterdam, Rotterdam University of Applied Sciences, Erasmus University Rotterdam, Avans University of applied sciences, InHolland University of Applied Sciences
- Responsible party
- Principal investigator, Sanne van Luenen, Universiteit Leiden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030244
- Sponsor's protocol ID
- Effects of Moodpep
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Outcomes and Predictive Factors of the Effectiveness and Adherence of Moodpep: an Online Self-help Intervention for College Students With Depressive Symptoms
- ClinicalTrials.gov ID
- NCT07030244
- Acronym / sponsor ID
- Effects of Moodpep
- Conditions
- Internet-based Intervention, Depression, Adherence, Predictors, Students, Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,050 participants (actual)
- Lead sponsor
- Universiteit LeidenUniversity, hospital or other
- Collaborators
- VU University of Amsterdam, Maastricht University, Utrecht University, University of Amsterdam, Rotterdam University of Applied Sciences, Erasmus University Rotterdam, Avans University of applied sciences, InHolland University of Applied Sciences
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 22 Jun 2025 (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.
Depressive symptoms are prevalent among college students and often remain untreated. E-health interventions may help overcome treatment barriers by offering accessible and flexible support. This study will evaluate the effects of Moodpep, a guided online intervention for college students with depressive symptoms, and will examine predictors of treatment success and adherence.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All students will start with Moodpep: a guided online self-help intervention for college students with depressive symptoms.
| Arm | Type | Receives |
|---|---|---|
| Moodpep | Experimental | Behavioral: MoodpepMoodpep is an online self-help intervention to reduce depressive symptoms in college students (Garnefski \& Kraaij, 2023). The intervention is based on CBT and consists of four main components in eight modules: behavioral activation, relaxation, changing negative cognitions and goal attainment. Students were advised to work on the intervention for one to two hours each week for about six to eight weeks. During the intervention, students received coaching via text messages on the platform. Coaches are trained Master's students in clinical psychology and they provided feedback on the assignments that students completed and motivated students to continue the intervention. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| MoodpepSee arm description | Behavioural | Moodpep |
Primary outcome
Depressive symptoms (PHQ-9)
Time frame: T0 (baseline), T1 (6 weeks post-baseline), T2 (6 months post-baseline)
Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001). Total scores range from 0 to 27 with higher scores indicating more depressive symptoms.
2 secondary outcomes
Adherence
Time frame: T1 (6 weeks post-baseline)
Predictors
Time frame: T0 (baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moodpep in people with Internet-based Intervention and Depression, run by Universiteit Leiden at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Depressive symptoms (PHQ-9) (time frame: T0 (baseline), T1 (6 weeks post-baseline), T2 (6 months post-baseline)). 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 27 Jun 2025.