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

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.

Study Overview

• Status: Completed
• Conditions: Self-Injurious Behavior; Depression, Anxiety
• Intervention / Treatment: Behavioral: Mindfulness plus mood monitoring; Behavioral: Mood monitoring

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.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Appleton, Wisconsin, United States, 54911
      • Lawrence University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• enrolled first-year student at university

Exclusion Criteria:

• serious suicidal concerns

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MIndfulness Plus Mood Monitoring; Mobile app that involved mood monitoring and brief mindfulness exercises.	Behavioral: Mindfulness plus mood monitoring; mobile app that provides guided mindfulness exercises in addition to prompting for mood monitoring three times per day
Active Comparator: Mood Monitoring Only; Mobile app that involved only mood monitoring	Behavioral: Mood monitoring; mobile app that prompts for mood monitoring three times per day
No Intervention: Assessment only Control; Only completed assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive Symptoms	Beck Depression Inventory; higher scores indicate greater depression	6 weeks following the intervention
Depressive Symptoms	Beck Depression Inventory; higher scores indicate greater depression	12 weeks following the intervention
Anxiety Symptoms	Beck Anxiety Inventory; higher scores indicate greater anxiety	6 weeks following the intervention
Anxiety Symptoms	Beck Anxiety Inventory; higher scores indicate greater anxiety	12 weeks following the intervention
Urges to self-injure	Alexian Brothers Urges to Self-Injure scale; higher scores indicate greater urges	6 weeks following the intervention
Urges to self-injure	Alexian Brothers Urges to Self-Injure scale; higher scores indicate greater urges	12 weeks following the intervention
Rumination	Ruminative Response Scale; higher scores indicate higher rumination	6 weeks following the intervention
Rumination	Ruminative Response Scale; higher scores indicate higher rumination	12 weeks following the intervention
Worry	Penn State Worry Questionnaire; higher scores indicate greater worry	6 weeks following the intervention
Worry	Penn State Worry Questionnaire; higher scores indicate greater worry	12 weeks following the intervention

Collaborators and Investigators

• Sponsor: Lawrence University
• Investigators: Principal Investigator: Lori M Hilt, PhD, Lawrence University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Actual): April 7, 2020
• Study Completion (Actual): June 17, 2020

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: mindfulness; worry; rumination
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior
• Other Study ID Numbers: 121119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified data available upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No