NCT06348277

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2020

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 4, 2024

Completed
Last Updated

April 4, 2024

Status Verified

March 1, 2024

Enrollment Period

2.3 years

First QC Date

March 20, 2024

Last Update Submit

March 28, 2024

Conditions

Keywords

mindfulnessruminationworry

Outcome Measures

Primary Outcomes (5)

  • Depressive Symptoms

    Beck Depression Inventory; higher scores indicate greater depression

    immediately after the intervention

  • Anxiety Symptoms

    Beck Anxiety Inventory; higher scores indicate greater anxiety

    immediately after the intervention

  • Urges to Self-injure

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

    immediately after the intervention

  • Rumination

    Ruminative Response Scale; higher scores indicate higher rumination

    immediately after the intervention

  • Worry

    Penn State Worry Questionnaire; higher scores indicate greater worry

    immediately after the intervention

Secondary Outcomes (10)

  • Depressive Symptoms

    6 weeks following the intervention

  • Depressive Symptoms

    12 weeks following the intervention

  • Anxiety Symptoms

    6 weeks following the intervention

  • Anxiety Symptoms

    12 weeks following the intervention

  • Urges to self-injure

    6 weeks following the intervention

  • +5 more secondary outcomes

Study Arms (3)

MIndfulness Plus Mood Monitoring

EXPERIMENTAL

Mobile app that involved mood monitoring and brief mindfulness exercises.

Behavioral: Mindfulness plus mood monitoring

Mood Monitoring Only

ACTIVE COMPARATOR

Mobile app that involved only mood monitoring

Behavioral: Mood monitoring

Assessment only Control

NO INTERVENTION

Only completed assessments

Interventions

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

MIndfulness Plus Mood Monitoring
Mood monitoringBEHAVIORAL

mobile app that prompts for mood monitoring three times per day

Mood Monitoring Only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • enrolled first-year student at university

You may not qualify if:

  • serious suicidal concerns

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lawrence University

Appleton, Wisconsin, 54911, United States

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersSelf-Injurious BehaviorRumination Syndrome

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersGastrointestinal DiseasesDigestive System DiseasesFeeding and Eating Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Lori M Hilt, PhD

    Lawrence University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2024

First Posted

April 4, 2024

Study Start

January 2, 2018

Primary Completion

April 7, 2020

Study Completion

June 17, 2020

Last Updated

April 4, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

De-identified data available upon request.

Locations