NCT07030244

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,050

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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 Start

First participant enrolled

June 1, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 12, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 22, 2025

Completed
Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

4 years

First QC Date

June 12, 2025

Last Update Submit

June 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    T0 (baseline), T1 (6 weeks post-baseline), T2 (6 months post-baseline)

Secondary Outcomes (2)

  • Adherence

    T1 (6 weeks post-baseline)

  • Predictors

    T0 (baseline)

Study Arms (1)

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.

Behavioral: Moodpep

Interventions

MoodpepBEHAVIORAL

See arm description

Moodpep

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VU Amsterdam

Amsterdam, Netherlands

Location

Leiden University

Leiden, Netherlands

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: All students will start with Moodpep: a guided online self-help intervention for college students with depressive symptoms.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 12, 2025

First Posted

June 22, 2025

Study Start

June 1, 2020

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

June 27, 2025

Record last verified: 2025-06

Locations