AnxietyNCT03328520
WILD 5 Wellness, A 30-Day Intervention
A study testing WILD 5 Wellness Intervention in people with Anxiety and Depression, run by Beloit College at 1 site in United States.
Trial summary
The purpose of this study is to explore the efficacy and feasibility of an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition in First Year Beloit College students self-selected into a wellness… Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression, Cognitive Functioning
- What is being tested?
- WILD 5 Wellness Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2017to 29 Nov 2017
- 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Students 18 years of age or older or 17 years of age with legal guardian written permission.
- Students enrolled in First Year Initiative Courses titled "Balance" or "Constructing Health"
Who cannot join
- Individuals who are pregnant or plan to get pregnant during the next 30 days.
- Students who are not enrolled in the First Year Initiative Courses titled "Balance" or "Constructing Health"
Trial locations and contacts
1 site in 1 country.
About this study
Official title: WILD 5 Wellness, A 30 Day Intervention in First Year Students at Beloit College
The purpose of this study is to explore the efficacy and feasibility of an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition in First Year Beloit College students self-selected into a wellness focused first year initiative. This program is called "WILD 5 Wellness: A 30-Day Intervention".
- Conditions
- Anxiety, Depression, Cognitive Functioning, Wellness
- Being tested
- WILD 5 Wellness Intervention
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WILD 5 Wellness InterventionBehavioural
Behaviors in 6 areas of wellness: Sleep, Social Connectedness, Exercise, Nutrition, Mindfulness and "HERO" (Happiness, Enthusiasm, Resilience, Optimism)
| Study group | Role | What they receive |
|---|---|---|
| First Year Students in Wellness FYIs | Experimental | Not described Receives: Behavioral: WILD 5 Wellness Intervention |
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)
PHQ-9 is a self reported depression scale. It is a 9-item scale with scores ranging from 0-27. Lower scores denote improvement.
Measured: Day 0, Day 30+ 3 days (approximately)
Change in Generalized Anxiety Disorder-7 (GAD-7)
GAD-7 is a self-reported questionnaire used to assess anxiety symptoms. It is a 7-item scale with scores ranging from 0-21. Lower score denotes improvement.
Measured: Day 0, Day 30+ 3 days (approximately)
Change in the HERO Wellness Scale
HERO Wellness Scale is a brief scale designed to measure mental wellness specifically happiness, enthusiasm, resilience and optimism. It is a 5-item scale with scores ranging from 0-10. Higher score denotes improvement.
Measured: Day 0, Day 30+ 3 days (approximately)
Change in World Health Organization-5 (WHO-5)
WHO-5 is a brief scale that measures mental well-being. It is a 5-item scale with scores ranging from 0-25. Higher score denotes improvement.
Measured: Day 0, Day 30+ 3 days (approximately)
Change in Cognitive and Physical Functioning Questionnaire (CPFQ)
CPFQ is a brief scale that measures cognitive and executive dysfunction. It is a 7-item scale with scores ranging from 7-42. Lower score denotes improvement.
Measured: Day 0, Day 30+ 3 days (approximately)
Secondary outcomes (1)
The Post-Program Participant Questionnaire
The Post-Program Participant Questionnaire is a brief survey that captures participants'opinions about WILD 5 Wellness.
Measured: Day 30+ 3 days (approximately)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start24 Oct 2017
- Primary completion29 Nov 2017
- Study completion29 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beloit College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tara M Girard, BSN, Principal investigator, Beloit CollegeSuzanne Cox, PhD, Principal investigator, Beloit CollegeLaura Parmentier, PhD, Principal investigator, Beloit CollegeSaundra Jain, PsyD, LPC, Principal investigator, Beloit CollegeRakesh Jain, MD, MPH, Principal investigator, Beloit College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328520
- Sponsor's protocol ID
- 374
- Status last verified
- Apr 2018
- First submitted
- 20 Oct 2017
- Last updated
- 26 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WILD 5 Wellness, A 30 Day Intervention in First Year Students at Beloit College
- ClinicalTrials.gov ID
- NCT03328520
- Acronym / sponsor ID
- 374
- Conditions
- Anxiety, Depression, Cognitive Functioning, Wellness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Beloit CollegeUniversity, hospital or other
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 29 Nov 2017 (actual)
- Study completion
- 29 Nov 2017 (actual)
- First posted
- 1 Nov 2017 (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 purpose of this study is to explore the efficacy and feasibility of an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition in First Year Beloit College students self-selected into a wellness focused first year initiative. This program is called "WILD 5 Wellness: A 30-Day Intervention".
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First Year Students in Wellness FYIs | Experimental | Behavioral: WILD 5 Wellness Intervention |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Students 18 years of age or older or 17 years of age with legal guardian written permission.
- Students enrolled in First Year Initiative Courses titled "Balance" or "Constructing Health"
Key exclusion criteria (2 listed)
- Individuals who are pregnant or plan to get pregnant during the next 30 days.
- Students who are not enrolled in the First Year Initiative Courses titled "Balance" or "Constructing Health"
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 |
|---|---|---|
| WILD 5 Wellness InterventionBehaviors in 6 areas of wellness: Sleep, Social Connectedness, Exercise, Nutrition, Mindfulness and "HERO" (Happiness, Enthusiasm, Resilience, Optimism) | Behavioural | First Year Students in Wellness FYIs |
Primary outcome
Change in Patient Health Questionnaire-9 (PHQ-9)
Time frame: Day 0, Day 30+ 3 days (approximately)
PHQ-9 is a self reported depression scale. It is a 9-item scale with scores ranging from 0-27. Lower scores denote improvement.
Change in Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Day 0, Day 30+ 3 days (approximately)
GAD-7 is a self-reported questionnaire used to assess anxiety symptoms. It is a 7-item scale with scores ranging from 0-21. Lower score denotes improvement.
Change in the HERO Wellness Scale
Time frame: Day 0, Day 30+ 3 days (approximately)
HERO Wellness Scale is a brief scale designed to measure mental wellness specifically happiness, enthusiasm, resilience and optimism. It is a 5-item scale with scores ranging from 0-10. Higher score denotes improvement.
Change in World Health Organization-5 (WHO-5)
Time frame: Day 0, Day 30+ 3 days (approximately)
WHO-5 is a brief scale that measures mental well-being. It is a 5-item scale with scores ranging from 0-25. Higher score denotes improvement.
Change in Cognitive and Physical Functioning Questionnaire (CPFQ)
Time frame: Day 0, Day 30+ 3 days (approximately)
CPFQ is a brief scale that measures cognitive and executive dysfunction. It is a 7-item scale with scores ranging from 7-42. Lower score denotes improvement.
1 secondary outcome
The Post-Program Participant Questionnaire
Time frame: Day 30+ 3 days (approximately)
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 26 Apr 2018.
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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.
Tara M Girard, BSN principal investigator
Beloit College
Suzanne Cox, PhD principal investigator
Beloit College
Laura Parmentier, PhD principal investigator
Beloit College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WILD 5 Wellness Intervention in people with Anxiety and Depression, run by Beloit College 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 2 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 26 Apr 2018. 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?
Change in Patient Health Questionnaire-9 (PHQ-9) (time frame: Day 0, Day 30+ 3 days (approximately)). 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 26 Apr 2018; AzTrials last refreshed its copy on 28 Oct 2026.