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Completed

NCT Number: NCT06348277

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.

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Key information

Conditions

Depression, Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Digestive System Diseases Feeding and Eating Disorders Gastrointestinal Diseases Mental Disorders Rumination Syndrome Self-Injurious Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lawrence University

Appleton, Wisconsin, 54911, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • enrolled first-year student at university

Exclusion criteria

  • serious suicidal concerns

Treatment and study plan

Mindfulness plus mood monitoring

Behavioral

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

Mood monitoring

Behavioral

mobile app that prompts for mood monitoring three times per day

Primary outcomes

  1. Depressive Symptoms

    Time frame: immediately after the intervention

    Beck Depression Inventory; higher scores indicate greater depression

  2. Anxiety Symptoms

    Time frame: immediately after the intervention

    Beck Anxiety Inventory; higher scores indicate greater anxiety

  3. Urges to Self-injure

    Time frame: immediately after the intervention

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

  4. Rumination

    Time frame: immediately after the intervention

    Ruminative Response Scale; higher scores indicate higher rumination

  5. Worry

    Time frame: immediately after the intervention

    Penn State Worry Questionnaire; higher scores indicate greater worry

Secondary outcomes

  1. Depressive Symptoms

    Time frame: 6 weeks following the intervention

    Beck Depression Inventory; higher scores indicate greater depression

  2. Depressive Symptoms

    Time frame: 12 weeks following the intervention

    Beck Depression Inventory; higher scores indicate greater depression

  3. Anxiety Symptoms

    Time frame: 6 weeks following the intervention

    Beck Anxiety Inventory; higher scores indicate greater anxiety

  4. Anxiety Symptoms

    Time frame: 12 weeks following the intervention

    Beck Anxiety Inventory; higher scores indicate greater anxiety

  5. Urges to self-injure

    Time frame: 6 weeks following the intervention

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

  6. Urges to self-injure

    Time frame: 12 weeks following the intervention

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

  7. Rumination

    Time frame: 6 weeks following the intervention

    Ruminative Response Scale; higher scores indicate higher rumination

  8. Rumination

    Time frame: 12 weeks following the intervention

    Ruminative Response Scale; higher scores indicate higher rumination

  9. Worry

    Time frame: 6 weeks following the intervention

    Penn State Worry Questionnaire; higher scores indicate greater worry

  10. Worry

    Time frame: 12 weeks following the intervention

    Penn State Worry Questionnaire; higher scores indicate greater worry

Sponsors and collaborators

Lead sponsor

Lawrence University

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 4, 2024
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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