Well-BeingNCT04287374
The Effects of Online Single-Session Interventions on College Student Well-being
A study testing Multi-component Well-being Intervention and Study Skills in people with Well-Being and Depressive Symptoms, run by University of Pennsylvania at 2 sites in United States.
Trial summary
This study seeks to investigate the effects of an online single-session intervention on college student mental health and well-being. Undergraduate students from the University of Pennsylvania and Harvard will be randomized to a 30-minute single-session intervention or a study skills control group. Read more about this study
- Who is it for?
- Ages 18 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Well-Being, Depressive Symptoms, Anxiety
- What is being tested?
- Multi-component Well-being Intervention and Study Skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 294 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Mar 2020to 31 Aug 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 to 22 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Current undergraduate student at select universities
- Able to access the internet
- Can participate in follow-up surveys for three months post sign-up
Who cannot join
- Unable to access the internet
- Will not be able to respond to the follow-up surveys post-intervention
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Harvard University
Cambridge, Massachusetts, 01434
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
This study seeks to investigate the effects of an online single-session intervention on college student mental health and well-being. Undergraduate students from the University of Pennsylvania and Harvard will be randomized to a 30-minute single-session intervention or a study skills control group. Students' depressive symptoms, anxiety symptoms, positive and negative affect, and subjective well-being will be assessed up to 12 weeks post-intervention.
Read the detailed description
The design of our study is a randomized control trial. After enrollment in the study, participants will randomly assigned to one of two conditions. In each condition, participants will be asked to complete an initial survey of mental health and well-being measures. Following this survey, participants will complete either a well-being skills single-session intervention or control single-session intervention (study skills) depending on which condition they were assigned to. These single-session interventions educate the participant on their focal concept and teach them exercises to improve that skill. Completing the single-session intervention will take approximately 20-30 minutes.
After completing their single-session intervention, all participants will retake the measures of mental health and well-being presented to them at the beginning of the program. Participants will also be asked to complete measures of intervention feasibility, acceptability and appropriateness at this time.
Following this initial intervention, participants will retake the measures of well-being and mental health at 2 weeks, 4 weeks, and 12 weeks after they completed the intervention. This will allow us to fulfill our first objective by determining how long single-session interventions improve undergraduate mental health and well-being.
- Conditions
- Well-Being, Depressive Symptoms, Anxiety, Affect
- Being tested
- Multi-component Well-being Intervention, Study Skills
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-component Well-being InterventionBehavioural
The intervention asks participants to complete exercises based on three different skills. These skills include cognitive restructuring, gratitude and behavioral activation. After completing the program, participants will pick their favorite exercise to complete on a weekly basis for homework. In order to increase compliance with the homework, participants will complete a short plan in which they will identify when, where and with who they will complete the homework. The whole intervention takes approximately 20-30 minutes to complete.
Study SkillsBehavioural
Participants are taught three different study skills/strategies. They are asked to make a plan to continue using these strategies after completing the intervention. The whole intervention takes approximately 20-30 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Multi-component Well-being Intervention | Experimental | Reading and writing activities based on cognitive restructuring (rephrasing automatic negative thoughts), gratitude (noticing and appreciating good things in life), and behavioral activation (identifying and scheduling positive activities) Receives: Behavioral: Multi-component Well-being Intervention |
| Study Skills Control | Sham comparator | Reading and writing activities designed to teach evidence-based study strategies. Receives: Behavioral: Study Skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Questionnaire-9 (PHQ-9)
Depression Questionnaire. The total score ranges from 0 to 27. Lower scores indicate a better outcome.
Measured: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up
Change in Generalized Anxiety Disorder Screener-7 (GAD-7)
Anxiety Questionnaire. The total score ranges from 0 to 21. Lower scores indicate a better outcome.
Measured: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up
Change in The Warwick-Edinburgh Mental Wellbeing Scale
Well-being questionnaire. Total score ranges from 14 to 70. Higher values indicate a better outcome.
Measured: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up
Secondary outcomes (7)
Acceptability of Intervention Measure
Questionnaire measuring the acceptability of an intervention. Acceptability refers to the perception that a given treatment is agreeable or satisfactory. The total score ranges from 4 to 20. Higher scores indicate a better outcome.
Measured: Immediately post-intervention (0 weeks)
Feasibility of Intervention Measure
Questionnaire measuring the feasibility of an intervention. Feasibility refers to the degree to which a treatment can be successfully implemented in a given setting. The total score ranges from 4 to 20. Higher scores indicate a better outcome.
Measured: Immediately post-intervention (0 weeks)
Intervention Appropriateness Measure
Questionnaire measuring the appropriateness of an intervention. Appropriateness refers to the perceived fit or relevance of an intervention. The total score ranges from 4 to 20. Higher scores indicate a better outcome.
Measured: Immediately post-intervention (0 weeks)
Change in Gratitude Questionnaire-6
Gratitude questionnaire. Total score ranges from 6 to 42. Higher scores indicate more gratitude.
Measured: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up
Change in Beck Hopelessness Scale (4-item version)
Hope Questionnaire. Total score ranges from 0 to 4. Higher scores indicate less hope (or more hopelessness).
Measured: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up
Change in Perceived Stress Scale-4
Perceived stress questionnaire. Total score ranges from 0 to 16. Higher scores indicate more stress.
Measured: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up
Change in Positive and Negative Affect Schedule
Affect Questionnaire. Scores range from 10-50 for positive affect and negative affect subscales. Higher scores represent higher levels of affect.
Measured: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start31 Mar 2020
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-BeingStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert DeRubeis, PhD, Study director, University of PennsylvaniaAkash Wasil, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287374
- Sponsor's protocol ID
- 834854
- Status last verified
- Sep 2020
- First submitted
- 24 Feb 2020
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Online Single-Session Interventions on College Student Well-being
- ClinicalTrials.gov ID
- NCT04287374
- Acronym / sponsor ID
- 834854
- Conditions
- Well-Being, Depressive Symptoms, Anxiety, Affect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 27 Feb 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.
This study seeks to investigate the effects of an online single-session intervention on college student mental health and well-being. Undergraduate students from the University of Pennsylvania and Harvard will be randomized to a 30-minute single-session intervention or a study skills control group. Students' depressive symptoms, anxiety symptoms, positive and negative affect, and subjective well-being will be assessed up to 12 weeks post-intervention.
Detailed description
The design of our study is a randomized control trial. After enrollment in the study, participants will randomly assigned to one of two conditions. In each condition, participants will be asked to complete an initial survey of mental health and well-being measures. Following this survey, participants will complete either a well-being skills single-session intervention or control single-session intervention (study skills) depending on which condition they were assigned to. These single-session interventions educate the participant on their focal concept and teach them exercises to improve that skill. Completing the single-session intervention will take approximately 20-30 minutes.
After completing their single-session intervention, all participants will retake the measures of mental health and well-being presented to them at the beginning of the program. Participants will also be asked to complete measures of intervention feasibility, acceptability and appropriateness at this time.
Following this initial intervention, participants will retake the measures of well-being and mental health at 2 weeks, 4 weeks, and 12 weeks after they completed the intervention. This will allow us to fulfill our first objective by determining how long single-session interventions improve undergraduate mental health and well-being.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-component Well-being Intervention | Experimental | Behavioral: Multi-component Well-being InterventionReading and writing activities based on cognitive restructuring (rephrasing automatic negative thoughts), gratitude (noticing and appreciating good things in life), and behavioral activation (identifying and scheduling positive activities) |
| Study Skills Control | Sham comparator | Behavioral: Study SkillsReading and writing activities designed to teach evidence-based study strategies. |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Current undergraduate student at select universities
- Able to access the internet
- Can participate in follow-up surveys for three months post sign-up
Key exclusion criteria (2 listed)
- Unable to access the internet
- Will not be able to respond to the follow-up surveys post-intervention
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 |
|---|---|---|
| Multi-component Well-being InterventionThe intervention asks participants to complete exercises based on three different skills. These skills include cognitive restructuring, gratitude and behavioral activation. After completing the program, participants will pick their favorite exercise to complete on a weekly basis for homework. In order to increase compliance with the homework, participants will complete a short plan in which they will identify when, where and with who they will complete the homework. The whole intervention takes approximately 20-30 minutes to complete. | Behavioural | Multi-component Well-being Intervention |
| Study SkillsParticipants are taught three different study skills/strategies. They are asked to make a plan to continue using these strategies after completing the intervention. The whole intervention takes approximately 20-30 minutes to complete. | Behavioural | Study Skills Control |
Primary outcome
Change in Patient Health Questionnaire-9 (PHQ-9)
Time frame: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up
Depression Questionnaire. The total score ranges from 0 to 27. Lower scores indicate a better outcome.
Change in Generalized Anxiety Disorder Screener-7 (GAD-7)
Time frame: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up
Anxiety Questionnaire. The total score ranges from 0 to 21. Lower scores indicate a better outcome.
Change in The Warwick-Edinburgh Mental Wellbeing Scale
Time frame: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up
Well-being questionnaire. Total score ranges from 14 to 70. Higher values indicate a better outcome.
7 secondary outcomes
Acceptability of Intervention Measure
Time frame: Immediately post-intervention (0 weeks)
Feasibility of Intervention Measure
Time frame: Immediately post-intervention (0 weeks)
Intervention Appropriateness Measure
Time frame: Immediately post-intervention (0 weeks)
Change in Gratitude Questionnaire-6
Time frame: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up
Change in Beck Hopelessness Scale (4-item version)
Time frame: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up
Change in Perceived Stress Scale-4
Time frame: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up
Change in Positive and Negative Affect Schedule
Time frame: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up
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 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Robert DeRubeis, PhD study director
University of Pennsylvania
Akash Wasil principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-component Well-being Intervention and Study Skills in people with Well-Being and Depressive Symptoms, run by University of Pennsylvania at 2 sites 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 3 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 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Change in Patient Health Questionnaire-9 (PHQ-9) (time frame: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up). 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 4 Sep 2020.