Emotional RegulationNCT04558411
Brief, Scaleable Intervention for Coronavirus (COVID-19) Mental Health Sequelae in College Students
A study testing Dialectical Behavioral Therapy (DBT) Skills in people with Emotional Regulation and Affect, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The major aim of this pilot study is to evaluate a brief coping skills intervention for college students, based on an evidence-based treatment and delivered remotely via 14 short daily videos. Participants will be 150 Rutgers undergraduates who are enrolled in Fall 2020. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emotional Regulation, Affect
- What is being tested?
- Dialectical Behavioral Therapy (DBT) Skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2020to 15 Dec 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
- Age 18 years or older
- Matriculated at Rutgers during Fall of 2020 (on campus and/or remote)
- Currently residing in the United States
- Willingness to follow study requirements, as evidenced by an ability to provide written informed consent and read, understand, and complete the study procedures
- iOS and Android smartphone compatible with MetricWire
Who cannot join
- Non-English speaking
- Unable to understand or provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers, The State University of New Jersey
Piscataway, New Jersey, 08854
About this study
Official title: Pilot Study of a Brief, Scaleable Intervention for COVID-19 Mental Health Sequelae in College Students
The major aim of this pilot study is to evaluate a brief coping skills intervention for college students, based on an evidence-based treatment and delivered remotely via 14 short daily videos. Participants will be 150 Rutgers undergraduates who are enrolled in Fall 2020. Participants in the experimental group (n=100) will receive 4 daily smartphone surveys assessing stress, affect, and other related factors for two weeks before, during, and after the 2-week coping skills intervention. Participants in the control group (n=50) will receive assessments over the same time period with no skills intervention. Both groups will be assessed weekly throughout the Fall semester to monitor the transition to the new semester and longer-term impact of the intervention. The control condition participants will have access to the skills videos at the end of the study.
- Conditions
- Emotional Regulation, Affect
- Being tested
- Dialectical Behavioral Therapy (DBT) Skills
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical Behavioral Therapy (DBT) SkillsBehavioural
14 brief videos that teach DBT skills.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (assessment only) | No intervention | This group will receive assessments only. |
| Assessment + Intervention Group | Experimental | This group will receive assessments and the 14 brief intervention videos. Receives: Behavioral: Dialectical Behavioral Therapy (DBT) Skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distress
Distress, as assessed via smartphone Ecological Momentary Assessment (EMA), 0 through 10 scale, 10 equals more distress.
Measured: Six week daily monitoring period
Emotion regulation
Assessed with the Difficulties in Emotion Regulation Scale (DERS); scores range from 36-180, higher scores equal more distress
Measured: Six week daily monitoring period
Distress (within-person change)
Assessed via EMA in the experimental group, 0 through 10 scale, 10 equals more distress.
Measured: Six week daily monitoring period
Secondary outcomes (1)
Maintenance of improvement in emotion regulation
Assessed with the Difficulties in Emotion Regulation Scale (DERS), scores range from 36-180, higher scores equal more distress
Measured: Six week post-daily monitoring period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start12 Sep 2020
- Primary completion15 Dec 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional RegulationStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shireen L. Rizvi, PhD, ABPP, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558411
- Sponsor's protocol ID
- Pro2020002008
- Status last verified
- Sep 2021
- First submitted
- 20 Sep 2020
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share data after the publication of primary manuscripts.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Brief, Scaleable Intervention for COVID-19 Mental Health Sequelae in College Students
- ClinicalTrials.gov ID
- NCT04558411
- Acronym / sponsor ID
- Pro2020002008
- Conditions
- Emotional Regulation, Affect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 12 Sep 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 22 Sep 2020 (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 major aim of this pilot study is to evaluate a brief coping skills intervention for college students, based on an evidence-based treatment and delivered remotely via 14 short daily videos. Participants will be 150 Rutgers undergraduates who are enrolled in Fall 2020. Participants in the experimental group (n=100) will receive 4 daily smartphone surveys assessing stress, affect, and other related factors for two weeks before, during, and after the 2-week coping skills intervention. Participants in the control group (n=50) will receive assessments over the same time period with no skills intervention. Both groups will be assessed weekly throughout the Fall semester to monitor the transition to the new semester and longer-term impact of the intervention. The control condition participants will have access to the skills videos at the end of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group (assessment only) | No intervention | –This group will receive assessments only. |
| Assessment + Intervention Group | Experimental | Behavioral: Dialectical Behavioral Therapy (DBT) SkillsThis group will receive assessments and the 14 brief intervention videos. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Matriculated at Rutgers during Fall of 2020 (on campus and/or remote)
- Currently residing in the United States
- Willingness to follow study requirements, as evidenced by an ability to provide written informed consent and read, understand, and complete the study procedures
- iOS and Android smartphone compatible with MetricWire
Key exclusion criteria (2 listed)
- Non-English speaking
- Unable to understand or provide informed consent
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 |
|---|---|---|
| Dialectical Behavioral Therapy (DBT) Skills14 brief videos that teach DBT skills. | Behavioural | Assessment + Intervention Group |
Primary outcome
Distress
Time frame: Six week daily monitoring period
Distress, as assessed via smartphone Ecological Momentary Assessment (EMA), 0 through 10 scale, 10 equals more distress.
Emotion regulation
Time frame: Six week daily monitoring period
Assessed with the Difficulties in Emotion Regulation Scale (DERS); scores range from 36-180, higher scores equal more distress
Distress (within-person change)
Time frame: Six week daily monitoring period
Assessed via EMA in the experimental group, 0 through 10 scale, 10 equals more distress.
1 secondary outcome
Maintenance of improvement in emotion regulation
Time frame: Six week post-daily monitoring period
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 29 Sep 2021.
- Individual participant dataSharing planned: Yes. We will share data after the publication of primary manuscripts.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectical Behavioral Therapy (DBT) Skills in people with Emotional Regulation and Affect, run by Rutgers, The State University of New Jersey 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 5 inclusion and 2 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 29 Sep 2021. 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?
Distress (time frame: Six week daily monitoring period). The study lists 3 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 29 Sep 2021.