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CompletedNCT06348277Updated Apr 4, 2024

Brief App-based Mood Monitoring and Mindfulness Intervention for First-year College Students

An interventional study of Mindfulness plus mood monitoring and Mood monitoring in Depression, Anxiety and Self-Injurious Behavior, sponsored by Lawrence University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-04.

Sponsored by Lawrence University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 years 2 months after the study started (first participant enrolled Jan 2018, registered Mar 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The investigators examined whether brief, app-based interventions were helpful in alleviating mental health symptoms during the transition to college. In particular, the investigators were interested in whether a brief mobile-app mindfulness intervention combined with mood monitoring was more effective in alleviating first-year students' psychological distress than mood monitoring alone.

Read the detailed description

The transition to college is associated with worsening mental health symptoms. This study tested whether a brief mobile-app mindfulness intervention combined with mood monitoring was more effective in alleviating first-year students' psychological distress than mood monitoring alone. Participants were 130 first-year students. The investigators randomly assigned 88 students to a mindfulness-plus-mood-monitoring or a mood-monitoring-only group and asked them to use an app 3 times a day for 3 weeks. They, along with an assessment-only control group (n=42), completed self-report questionnaires at baseline, post-intervention, and 6 and 12 weeks later.

02

Conditions studied

  • Depression, Anxiety
  • Self-Injurious Behavior

Keywords

  • mindfulness
  • rumination
  • worry
03

In context

Depression

8,245 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 130 is above the median of 84 across 6,869 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Lawrence University is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • enrolled first-year student at university

Exclusion criteria

Exclusion Criteria:

  • serious suicidal concerns
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
130 participants (actual)

Study arms

  • Experimental
    MIndfulness Plus Mood Monitoring

    Mobile app that involved mood monitoring and brief mindfulness exercises.

    Behavioral: Mindfulness plus mood monitoring

  • Active comparator
    Mood Monitoring Only

    Mobile app that involved only mood monitoring

    Behavioral: Mood monitoring

  • No intervention
    Assessment only Control

    Only completed assessments

Interventions

  • BehavioralMindfulness plus mood monitoring

    mobile app that provides guided mindfulness exercises in addition to prompting for mood monitoring three times per day

  • BehavioralMood monitoring

    mobile app that prompts for mood monitoring three times per day

06

What researchers measure

Primary outcomes

  1. Depressive Symptoms

    Beck Depression Inventory; higher scores indicate greater depression

    Time frame: immediately after the intervention

  2. Anxiety Symptoms

    Beck Anxiety Inventory; higher scores indicate greater anxiety

    Time frame: immediately after the intervention

  3. Urges to Self-injure

    Alexian Brothers Urges to Self-Injure scale; higher scores indicate greater urges

    Time frame: immediately after the intervention

  4. Rumination

    Ruminative Response Scale; higher scores indicate higher rumination

    Time frame: immediately after the intervention

  5. Worry

    Penn State Worry Questionnaire; higher scores indicate greater worry

    Time frame: immediately after the intervention

Secondary outcomes

  1. Depressive Symptoms

    Beck Depression Inventory; higher scores indicate greater depression

    Time frame: 6 weeks following the intervention

  2. Depressive Symptoms

    Beck Depression Inventory; higher scores indicate greater depression

    Time frame: 12 weeks following the intervention

  3. Anxiety Symptoms

    Beck Anxiety Inventory; higher scores indicate greater anxiety

    Time frame: 6 weeks following the intervention

  4. Anxiety Symptoms

    Beck Anxiety Inventory; higher scores indicate greater anxiety

    Time frame: 12 weeks following the intervention

  5. Urges to self-injure

    Alexian Brothers Urges to Self-Injure scale; higher scores indicate greater urges

    Time frame: 6 weeks following the intervention

  6. Urges to self-injure

    Alexian Brothers Urges to Self-Injure scale; higher scores indicate greater urges

    Time frame: 12 weeks following the intervention

  7. Rumination

    Ruminative Response Scale; higher scores indicate higher rumination

    Time frame: 6 weeks following the intervention

  8. Rumination

    Ruminative Response Scale; higher scores indicate higher rumination

    Time frame: 12 weeks following the intervention

  9. Worry

    Penn State Worry Questionnaire; higher scores indicate greater worry

    Time frame: 6 weeks following the intervention

  10. Worry

    Penn State Worry Questionnaire; higher scores indicate greater worry

    Time frame: 12 weeks following the intervention

07

Study locations

1 site
  • Lawrence University
    Appleton, Wisconsin 54911, United States
08

References and documents

Individual participant data

Plan to share: No — De-identified data available upon request.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06348277
Lead sponsor
Lawrence University
Responsible party
Sponsor
First posted
Apr 4, 2024
Start date
Jan 2, 2018
Primary completion
Apr 7, 2020
Completion
Jun 17, 2020
Last update
Apr 4, 2024

Study contacts

Lori M Hilt, PhD
principal investigator · Lawrence University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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