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

Primary Purpose

Chronic Pain, Stress, Psychological, Healthy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wellness Element 1 - Exercise
Wellness Element 2 - Mindfulness
Wellness Element 3 - Sleep Hygiene
Wellness Element 4 - Social Connectedness
Wellness Element 5 - Nutrition
Wellness Element 6 - Wellness Exercises
Wellness Element 7 - Motivational Messages
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Wellness, Mental Wellness, Well-Being

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Texas at Austin School of Nursing

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Wellness Intervention

Arm Description

WILD 5 Wellness is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.

Outcomes

Primary Outcome Measures

Change in Patient Health Questionnaire-9 (PHQ-9)
A self-reported depression scale used to assess severity of depression.
Change in Generalized Anxiety Disorder-7 (GAD-7)
A self-reported questionnaire used to assess anxiety symptoms.
Change in World Health Organization-5 (WHO-5)
A brief scale that measures mental well- being.
Change in The Mindful Attention Awareness Scale (MAAS)
A popular measure of mindfulness.
Change in The Sleep Condition Indicator (SCI)
A brief scale that evaluates insomnia disorder.
Change in The Social Connectedness Scale (SCS)
A brief scale that assesses the degree to which respondents feel connected to others.
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.
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.
Change in The Brief Pain Inventory (BPI)
A measurement tool for assessing clinical pain.
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.
Change in The Endicott Work Productivity Scale (EWPS)
A brief self-report questionnaire designed to obtain a sensitive measure of work productivity.
Change in Cognitive and Physical Functioning Questionnaire (CPFQ)
A brief scale that measures cognitive and executive dysfunction.
Change in The WILD 5 Wellness Scale (W5WS)
A brief scale designed specifically for this project to measure wellness.
Change in The WILD 5 Wellness Effort Scale (W5ES)
A scale designed specifically for this project to measure weekly adherence with program elements.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 25, 2016
Last Updated
April 3, 2019
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT02918513
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
June 12, 2018 (Actual)
Study Completion Date
August 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Stress, Psychological, Healthy
Keywords
Wellness, Mental Wellness, Well-Being

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wellness Intervention
Arm Type
Experimental
Arm Description
WILD 5 Wellness is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.
Intervention Type
Behavioral
Intervention Name(s)
Wellness Element 1 - Exercise
Intervention Description
1. Daily wellness element focusing on Exercise; adherence documented online daily
Intervention Type
Behavioral
Intervention Name(s)
Wellness Element 2 - Mindfulness
Intervention Description
2. Daily wellness element focusing on Mindfulness Meditation; adherence documented online daily
Intervention Type
Behavioral
Intervention Name(s)
Wellness Element 3 - Sleep Hygiene
Intervention Description
3. Daily wellness element focusing on sleep hygiene; adherence documented online daily
Intervention Type
Behavioral
Intervention Name(s)
Wellness Element 4 - Social Connectedness
Intervention Description
4. Daily wellness element focusing on Social Connectedness; adherence documented online daily
Intervention Type
Behavioral
Intervention Name(s)
Wellness Element 5 - Nutrition
Intervention Description
5. Daily wellness element focusing on Nutrition; adherence documented online daily
Intervention Type
Behavioral
Intervention Name(s)
Wellness Element 6 - Wellness Exercises
Intervention Description
6. Daily wellness workbook exercises focusing on improving mental wellness; adherence documented online daily
Intervention Type
Behavioral
Intervention Name(s)
Wellness Element 7 - Motivational Messages
Intervention Description
7. Daily motivational emails offering information on one of the 5 wellness elements each day (Exercise, Mindfulness Meditation, Sleep, Social Connectedness, and Nutrition)
Primary Outcome Measure Information:
Title
Change in Patient Health Questionnaire-9 (PHQ-9)
Description
A self-reported depression scale used to assess severity of depression.
Time Frame
0, 30, and 90 days - Primary endpoint is 30 days
Title
Change in Generalized Anxiety Disorder-7 (GAD-7)
Description
A self-reported questionnaire used to assess anxiety symptoms.
Time Frame
0, 30, and 90 days - Primary endpoint is 30 days
Title
Change in World Health Organization-5 (WHO-5)
Description
A brief scale that measures mental well- being.
Time Frame
0, 30, and 90 days - Primary endpoint is 30 days
Title
Change in The Mindful Attention Awareness Scale (MAAS)
Description
A popular measure of mindfulness.
Time Frame
0, 30, and 90 days - Primary endpoint is 30 days
Title
Change in The Sleep Condition Indicator (SCI)
Description
A brief scale that evaluates insomnia disorder.
Time Frame
0, 30, and 90 days - Primary endpoint is 30 days
Title
Change in The Social Connectedness Scale (SCS)
Description
A brief scale that assesses the degree to which respondents feel connected to others.
Time Frame
0, 30, and 90 days - Primary endpoint is 30 days
Title
Change in Eating and Appraisal Due to Emotions and Stress (EADES)
Description
A scale assessing how individuals cope with and appraise stress in relation to food and eating.
Time Frame
0, 30, and 90 days - Primary endpoint is 30 days
Title
Change in The Mediterranean-Dietary Approaches to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND)
Description
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.
Time Frame
0, 30, and 90 - Primary endpoint is 30 days
Title
Change in The Brief Pain Inventory (BPI)
Description
A measurement tool for assessing clinical pain.
Time Frame
0, 30, and 90 days - Primary endpoint is 30 days
Title
Change in The Sheehan Disability Scale (SDS)
Description
A measurement tool for assessing functional impairment in three inter-related domains: work/school, social and family life.
Time Frame
0, 30, and 90 days - Primary endpoint is 30 days
Title
Change in The Endicott Work Productivity Scale (EWPS)
Description
A brief self-report questionnaire designed to obtain a sensitive measure of work productivity.
Time Frame
0, 30, and 90 days - Primary endpoint is 30 days
Title
Change in Cognitive and Physical Functioning Questionnaire (CPFQ)
Description
A brief scale that measures cognitive and executive dysfunction.
Time Frame
0, 30, and 90 days - Primary endpoint is 30 days
Title
Change in The WILD 5 Wellness Scale (W5WS)
Description
A brief scale designed specifically for this project to measure wellness.
Time Frame
0, 30, and 90 days - Primary endpoint is 30 days
Title
Change in The WILD 5 Wellness Effort Scale (W5ES)
Description
A scale designed specifically for this project to measure weekly adherence with program elements.
Time Frame
0, 30, and 90 days - Primary endpoint is 30 days
Title
Change in The WILD 5 Wellness Elements Scale
Description
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.
Time Frame
0, 30, and 90 days - Primary endpoint is 30 days
Title
The Post-Program Participant Questionnaire
Description
A brief post study survey that captures participants' opinions about WILD 5 Wellness: 90-Day Intervention, and subjective ranking of their overall wellness.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saundra M Jain, PsyD, LPC
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas at Austin School of Nursing
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24026850
Citation
Cooney GM, Dwan K, Greig CA, Lawlor DA, Rimer J, Waugh FR, McMurdo M, Mead GE. Exercise for depression. Cochrane Database Syst Rev. 2013 Sep 12;2013(9):CD004366. doi: 10.1002/14651858.CD004366.pub6.
Results Reference
result
PubMed Identifier
24331897
Citation
Cruwys T, Dingle GA, Haslam C, Haslam SA, Jetten J, Morton TA. Social group memberships protect against future depression, alleviate depression symptoms and prevent depression relapse. Soc Sci Med. 2013 Dec;98:179-86. doi: 10.1016/j.socscimed.2013.09.013. Epub 2013 Sep 25.
Results Reference
result
PubMed Identifier
25406801
Citation
Fardet A, Boirie Y. Associations between food and beverage groups and major diet-related chronic diseases: an exhaustive review of pooled/meta-analyses and systematic reviews. Nutr Rev. 2014 Dec;72(12):741-62. doi: 10.1111/nure.12153. Epub 2014 Nov 18.
Results Reference
result
PubMed Identifier
26046013
Citation
Hui SK, Grandner MA. Associations between Poor Sleep Quality and Stages of Change of Multiple Health Behaviors among Participants of Employee Wellness Program. Prev Med Rep. 2015 Jan 1;2:292-299. doi: 10.1016/j.pmedr.2015.04.002.
Results Reference
result
PubMed Identifier
26132670
Citation
Jeste DV, Palmer BW, Rettew DC, Boardman S. Positive psychiatry: its time has come. J Clin Psychiatry. 2015 Jun;76(6):675-83. doi: 10.4088/JCP.14nr09599.
Results Reference
result
PubMed Identifier
24294837
Citation
Williams JM, Crane C, Barnhofer T, Brennan K, Duggan DS, Fennell MJ, Hackmann A, Krusche A, Muse K, Von Rohr IR, Shah D, Crane RS, Eames C, Jones M, Radford S, Silverton S, Sun Y, Weatherley-Jones E, Whitaker CJ, Russell D, Russell IT. Mindfulness-based cognitive therapy for preventing relapse in recurrent depression: a randomized dismantling trial. J Consult Clin Psychol. 2014 Apr;82(2):275-86. doi: 10.1037/a0035036. Epub 2013 Dec 2.
Results Reference
result
Links:
URL
https://www.qualtrics.com/security-statement/
Description
Qualtrics security statement
URL
https://security.utexas.edu/iso-policies/cloud-services/decision-matrix
Description
Decision matrix: Cloud services
URL
http://www.mailchimp.com/
Description
Online automated email service
URL
https://youtu.be/L_VIAnck05c
Description
Program Overview Video

Learn more about this trial

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

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