Clinical trial NCT02918513: WILD 5 Wellness: A 90-Day Intervention (WILD = Wellness Interventions for Life's Demands)
Official title: WILD 5 Wellness: A 90-Day Intervention (WILD = Wellness Interventions for Life's Demands)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Stress, Psychological
Healthy
Keywords: Wellness
Mental Wellness
Well-Being
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2016-09-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 0, 30, and 90 days - Primary endpoint is 30 days
measure: Change in Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 0, 30, and 90 days - Primary endpoint is 30 days
measure: Change in World Health Organization-5 (WHO-5)
timeFrame: 0, 30, and 90 days - Primary endpoint is 30 days
measure: Change in The Mindful Attention Awareness Scale (MAAS)
timeFrame: 0, 30, and 90 days - Primary endpoint is 30 days
measure: Change in The Sleep Condition Indicator (SCI)
timeFrame: 0, 30, and 90 days - Primary endpoint is 30 days
measure: Change in The Social Connectedness Scale (SCS)
timeFrame: 0, 30, and 90 days - Primary endpoint is 30 days
measure: Change in Eating and Appraisal Due to Emotions and Stress (EADES)
timeFrame: 0, 30, and 90 days - Primary endpoint is 30 days
measure: Change in The Mediterranean-Dietary Approaches to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND)
timeFrame: 0, 30, and 90 - Primary endpoint is 30 days
measure: Change in The Brief Pain Inventory (BPI)
timeFrame: 0, 30, and 90 days - Primary endpoint is 30 days
measure: Change in The Sheehan Disability Scale (SDS)
timeFrame: 0, 30, and 90 days - Primary endpoint is 30 days
measure: Change in The Endicott Work Productivity Scale (EWPS)
timeFrame: 0, 30, and 90 days - Primary endpoint is 30 days
measure: Change in Cognitive and Physical Functioning Questionnaire (CPFQ)
timeFrame: 0, 30, and 90 days - Primary endpoint is 30 days
measure: Change in The WILD 5 Wellness Scale (W5WS)
timeFrame: 0, 30, and 90 days - Primary endpoint is 30 days
measure: Change in The WILD 5 Wellness Effort Scale (W5ES)
timeFrame: 0, 30, and 90 days - Primary endpoint is 30 days
measure: Change in The WILD 5 Wellness Elements Scale
timeFrame: 0, 30, and 90 days - Primary endpoint is 30 days
measure: The Post-Program Participant Questionnaire
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin School of Nursing
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Saundra M Jain, PsyD, LPC
role: PRINCIPAL_INVESTIGATOR
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