Depression, AnxietyNCT06348277
Brief App-based Mood Monitoring and Mindfulness Intervention for First-year College Students
A study testing Mindfulness plus mood monitoring and Mood monitoring in people with Depression, Anxiety and Self-Injurious Behavior, run by Lawrence University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Self-Injurious Behavior
- What is being tested?
- Mindfulness plus mood monitoring and Mood monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2018to 17 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- enrolled first-year student at university
Who cannot join
- serious suicidal concerns
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Depression, Anxiety, Self-Injurious Behavior
- Being tested
- Mindfulness plus mood monitoring, Mood monitoring
- Keywords
- mindfulness, rumination, worry
- Medical subject headings
- Depression, Anxiety Disorders, Self-Injurious Behavior, Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness plus mood monitoringBehavioural
mobile app that provides guided mindfulness exercises in addition to prompting for mood monitoring three times per day
Mood monitoringBehavioural
mobile app that prompts for mood monitoring three times per day
| Study group | Role | What they receive |
|---|---|---|
| MIndfulness Plus Mood Monitoring | Experimental | Mobile app that involved mood monitoring and brief mindfulness exercises. Receives: Behavioral: Mindfulness plus mood monitoring |
| Mood Monitoring Only | Active comparator | Mobile app that involved only mood monitoring Receives: Behavioral: Mood monitoring |
| Assessment only Control | No intervention | Only completed assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptoms
Beck Depression Inventory; higher scores indicate greater depression
Measured: immediately after the intervention
Anxiety Symptoms
Beck Anxiety Inventory; higher scores indicate greater anxiety
Measured: immediately after the intervention
Urges to Self-injure
Alexian Brothers Urges to Self-Injure scale; higher scores indicate greater urges
Measured: immediately after the intervention
Rumination
Ruminative Response Scale; higher scores indicate higher rumination
Measured: immediately after the intervention
Worry
Penn State Worry Questionnaire; higher scores indicate greater worry
Measured: immediately after the intervention
Secondary outcomes (10)
Depressive Symptoms
Beck Depression Inventory; higher scores indicate greater depression
Measured: 6 weeks following the intervention
Depressive Symptoms
Beck Depression Inventory; higher scores indicate greater depression
Measured: 12 weeks following the intervention
Anxiety Symptoms
Beck Anxiety Inventory; higher scores indicate greater anxiety
Measured: 6 weeks following the intervention
Anxiety Symptoms
Beck Anxiety Inventory; higher scores indicate greater anxiety
Measured: 12 weeks following the intervention
Urges to self-injure
Alexian Brothers Urges to Self-Injure scale; higher scores indicate greater urges
Measured: 6 weeks following the intervention
Urges to self-injure
Alexian Brothers Urges to Self-Injure scale; higher scores indicate greater urges
Measured: 12 weeks following the intervention
Rumination
Ruminative Response Scale; higher scores indicate higher rumination
Measured: 6 weeks following the intervention
Rumination
Ruminative Response Scale; higher scores indicate higher rumination
Measured: 12 weeks following the intervention
Worry
Penn State Worry Questionnaire; higher scores indicate greater worry
Measured: 6 weeks following the intervention
Worry
Penn State Worry Questionnaire; higher scores indicate greater worry
Measured: 12 weeks following the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start2 Jan 2018
- Primary completion7 Apr 2020
- Study completion17 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lawrence University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lori M Hilt, PhD, Principal investigator, Lawrence University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348277
- Sponsor's protocol ID
- 121119
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief App-based Mood Monitoring and Mindfulness Intervention for First-year College Students
- ClinicalTrials.gov ID
- NCT06348277
- Acronym / sponsor ID
- 121119
- Conditions
- Depression, Anxiety, Self-Injurious Behavior
- Keywords
- mindfulness, rumination, worry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Lawrence UniversityUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 7 Apr 2020 (actual)
- Study completion
- 17 Jun 2020 (actual)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MIndfulness Plus Mood Monitoring | Experimental | Behavioral: Mindfulness plus mood monitoringMobile app that involved mood monitoring and brief mindfulness exercises. |
| Mood Monitoring Only | Active comparator | Behavioral: Mood monitoringMobile app that involved only mood monitoring |
| Assessment only Control | No intervention | –Only completed assessments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- enrolled first-year student at university
Key exclusion criteria (1 listed)
- serious suicidal concerns
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness plus mood monitoringmobile app that provides guided mindfulness exercises in addition to prompting for mood monitoring three times per day | Behavioural | MIndfulness Plus Mood Monitoring |
| Mood monitoringmobile app that prompts for mood monitoring three times per day | Behavioural | Mood Monitoring Only |
Primary outcome
Depressive Symptoms
Time frame: immediately after the intervention
Beck Depression Inventory; higher scores indicate greater depression
Anxiety Symptoms
Time frame: immediately after the intervention
Beck Anxiety Inventory; higher scores indicate greater anxiety
Urges to Self-injure
Time frame: immediately after the intervention
Alexian Brothers Urges to Self-Injure scale; higher scores indicate greater urges
Rumination
Time frame: immediately after the intervention
Ruminative Response Scale; higher scores indicate higher rumination
Worry
Time frame: immediately after the intervention
Penn State Worry Questionnaire; higher scores indicate greater worry
10 secondary outcomes
Depressive Symptoms
Time frame: 6 weeks following the intervention
Depressive Symptoms
Time frame: 12 weeks following the intervention
Anxiety Symptoms
Time frame: 6 weeks following the intervention
Anxiety Symptoms
Time frame: 12 weeks following the intervention
Urges to self-injure
Time frame: 6 weeks following the intervention
Urges to self-injure
Time frame: 12 weeks following the intervention
Rumination
Time frame: 6 weeks following the intervention
Rumination
Time frame: 12 weeks following the intervention
Worry
Time frame: 6 weeks following the intervention
Worry
Time frame: 12 weeks following the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: No. De-identified data available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori M Hilt, PhD principal investigator
Lawrence University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness plus mood monitoring and Mood monitoring in people with Depression, Anxiety and Self-Injurious Behavior, run by Lawrence University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive Symptoms (time frame: immediately after the intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.