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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06348277
Other study ID # 121119
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2, 2018
Est. completion date June 17, 2020

Study information

Verified date March 2024
Source Lawrence University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date June 17, 2020
Est. primary completion date April 7, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - enrolled first-year student at university Exclusion Criteria: - serious suicidal concerns

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mindfulness plus mood monitoring
mobile app that provides guided mindfulness exercises in addition to prompting for mood monitoring three times per day
Mood monitoring
mobile app that prompts for mood monitoring three times per day

Locations

Country Name City State
United States Lawrence University Appleton Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
Lawrence University

Country where clinical trial is conducted

United States, 

Outcome

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