WILD 5 Wellness: A 90-Day Intervention (WILD = Wellness Interventions for Life's Demands)

Study Overview
=================
Brief 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.

Detailed Description
-----------------
This study involves participating in a 90-day integrated, prescriptive, trackable wellness intervention, which includes five wellness elements: exercise, mindfulness, sleep, social connectedness, and nutrition. The intervention is divided into three phases (each spanning 30-days): Phase 1 - 'Boot Camp', Phase 2 - Solidify, and Phase 3 - Sustain. Program requirements include: Implementing 5 wellness interventions daily for the first 30-days, at least 5 days for the next 30-days, and at least 3 days for the final 30-days, documenting daily online adherence, completing daily wellness exercises to improve mental wellness, and completing online program forms prior to beginning the program, at 30-days, and again at 90-days. Once eligibility is confirmed via the initial orientation/screening call, study personnel will mail each participant a WILD 5 Wellness Workbook within one day of emailing participants their unique identification codes plus their start dates. Participants will be instructed to document adherence regarding their daily wellness practices and their daily wellness exercises online via Qualtrics, an online survey software. Participants can document their daily adherence using their computer and/or their smartphone as Qualtrics offers a mobile version of the Participant Tracking Form. A copy of the Participant Tracking Form will also be available in the WILD 5 Workbook so participants that prefer keeping a daily paper log can do so, and they can then transfer their program adherence information to the online Participant Tracking Form throughout the program. The workbook will contain the participant's personal identification code; no personal identification will appear in the workbook in order to protect participant confidentiality. One day prior to a participant's start date, which will be set during the orientation/screening call, participants will receive an automated email from an online automated email service (MailChimp), with a reminder about their start date, and encouragement to contact study personnel with any questions or concerns. Participants will also receive daily motivational emails from an online automated email service (MailChimp), which will provide general information about one of the five wellness elements and/or one of the wellness exercises, as well as encouragement to track their participation on a daily basis, and encouragement to contact study personnel via email with any questions and/or concerns.

Official Title
-----------------
WILD 5 Wellness: A 90-Day Intervention (WILD = Wellness Interventions for Life's Demands)

Conditions
-----------------
Chronic Pain, Stress, Psychological, Healthy

Intervention / Treatment
-----------------
* Behavioral: Wellness Element 1 - Exercise
* Behavioral: Wellness Element 2 - Mindfulness
* Behavioral: Wellness Element 3 - Sleep Hygiene
* Behavioral: Wellness Element 4 - Social Connectedness
* Behavioral: Wellness Element 5 - Nutrition
* Behavioral: Wellness Element 6 - Wellness Exercises
* Behavioral: Wellness Element 7 - Motivational Messages


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (18 years of age or older) English- speaking Access to a reliable Internet-enabled computer Possess basic computer skills Self-identify as having at least one of the health conditions listed on the online registration form or Self-identify as a community participant without a health condition. Exclusion Criteria: Acutely suicidal and/or actively psychotic Non-English speaking Do not have access to an Internet-enabled computer Report a lack of basic computer skills Pregnant or plan to get pregnant during the next 90-days.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wellness Intervention<br>WILD 5 Wellness is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition. | Behavioral: Wellness Element 1 - Exercise<br>* 1. Daily wellness element focusing on Exercise; adherence documented online daily<br>Behavioral: Wellness Element 2 - Mindfulness<br>* 2. Daily wellness element focusing on Mindfulness Meditation; adherence documented online daily<br>Behavioral: Wellness Element 3 - Sleep Hygiene<br>* 3. Daily wellness element focusing on sleep hygiene; adherence documented online daily<br>Behavioral: Wellness Element 4 - Social Connectedness<br>* 4. Daily wellness element focusing on Social Connectedness; adherence documented online daily<br>Behavioral: Wellness Element 5 - Nutrition<br>* 5. Daily wellness element focusing on Nutrition; adherence documented online daily<br>Behavioral: Wellness Element 6 - Wellness Exercises<br>* 6. Daily wellness workbook exercises focusing on improving mental wellness; adherence documented online daily<br>Behavioral: Wellness Element 7 - Motivational Messages<br>* 7. Daily motivational emails offering information on one of the 5 wellness elements each day (Exercise, Mindfulness Meditation, Sleep, Social Connectedness, and Nutrition)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Health Questionnaire-9 (PHQ-9) | A self-reported depression scale used to assess severity of depression. | 0, 30, and 90 days - Primary endpoint is 30 days | 
| Change in Generalized Anxiety Disorder-7 (GAD-7) | A self-reported questionnaire used to assess anxiety symptoms. | 0, 30, and 90 days - Primary endpoint is 30 days | 
| Change in World Health Organization-5 (WHO-5) | A brief scale that measures mental well- being. | 0, 30, and 90 days - Primary endpoint is 30 days | 
| Change in The Mindful Attention Awareness Scale (MAAS) | A popular measure of mindfulness. | 0, 30, and 90 days - Primary endpoint is 30 days | 
| Change in The Sleep Condition Indicator (SCI) | A brief scale that evaluates insomnia disorder. | 0, 30, and 90 days - Primary endpoint is 30 days | 
| Change in The Social Connectedness Scale (SCS) | A brief scale that assesses the degree to which respondents feel connected to others. | 0, 30, and 90 days - Primary endpoint is 30 days | 
| Change in Eating and Appraisal Due to Emotions and Stress (EADES) | A scale assessing how individuals cope with and appraise stress in relation to food and eating. | 0, 30, and 90 days - Primary endpoint is 30 days | 
| Change in The Mediterranean-Dietary Approaches to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND) | A combination of the Mediterranean and DASH (Dietary Approaches to Stop Hypertension) diets shown to lower a person's risk of developing Alzheimer's disease. | 0, 30, and 90 - Primary endpoint is 30 days | 
| Change in The Brief Pain Inventory (BPI) | A measurement tool for assessing clinical pain. | 0, 30, and 90 days - Primary endpoint is 30 days | 
| Change in The Sheehan Disability Scale (SDS) | A measurement tool for assessing functional impairment in three inter-related domains: work/school, social and family life. | 0, 30, and 90 days - Primary endpoint is 30 days | 
| Change in The Endicott Work Productivity Scale (EWPS) | A brief self-report questionnaire designed to obtain a sensitive measure of work productivity. | 0, 30, and 90 days - Primary endpoint is 30 days | 
| Change in Cognitive and Physical Functioning Questionnaire (CPFQ) | A brief scale that measures cognitive and executive dysfunction. | 0, 30, and 90 days - Primary endpoint is 30 days | 
| Change in The WILD 5 Wellness Scale (W5WS) | A brief scale designed specifically for this project to measure wellness. | 0, 30, and 90 days - Primary endpoint is 30 days | 
| Change in The WILD 5 Wellness Effort Scale (W5ES) | A scale designed specifically for this project to measure weekly adherence with program elements. | 0, 30, and 90 days - Primary endpoint is 30 days | 
| Change in The WILD 5 Wellness Elements Scale | A scale designed specifically for this project to measure elements of depression, anxiety, wellbeing, mindfulness, sleep quality, social connectedness, emotional eating, diet practices, pain, disability, work productivity, happiness, enthusiasm, resilience, and optimism. | 0, 30, and 90 days - Primary endpoint is 30 days | 
| The Post-Program Participant Questionnaire | A brief post study survey that captures participants' opinions about WILD 5 Wellness: 90-Day Intervention, and subjective ranking of their overall wellness. | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wellness, Mental Wellness, Well-Being