NCT04459728

Brief Summary

This study explores the efficacy and feasibility of a self-management wellness intervention that is integrated, prescriptive, and trackable in a population of registered nurses in the state of Texas enrolled in the TExas Peer Assistance Program for Nurses (TPAPN). This 30-day wellness intervention (called "KickStart30") combines five wellness elements: exercise,mindfulness, sleep, social connectedness, and nutrition. Additionally, the program requires that participants implement 5 wellness interventions daily for the 30-day study, document daily online adherence, complete daily HERO (happiness, enthusiasm, resilience, and optimism) exercises to improve mental wellness, and complete online program forms before and after the 30-day intervention. Participants are assessed pre- and post-intervention to determine whether the intervention promotes wellness behavior changes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2022

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2022

Completed
Last Updated

July 18, 2022

Status Verified

July 1, 2022

Enrollment Period

1.8 years

First QC Date

July 2, 2020

Last Update Submit

July 14, 2022

Conditions

Keywords

Substance Use, Registered Nurses, Wellness Programs

Outcome Measures

Primary Outcomes (1)

  • Change in HERO Wellness Scale

    Brief scale that measures 4 wellness traits plus perceived mental wellness

    0, and 30 days

Secondary Outcomes (12)

  • Change in Patient Health Questionnaire-9 (PHQ-9)

    0, and 30 days

  • Change in Generalized Anxiety Disorder-7 (GAD-7)

    0, and 30 days

  • Change in World Health Organization Well-Being Index (WHO-5)

    0, and 30 days

  • Change in the Short Inventory of Problems Revised (SIP-R),

    0, and 30 days

  • Change in Patient Safety Screener (PSS-3)

    0, and 30 days

  • +7 more secondary outcomes

Study Arms (1)

Wellness Intervention

EXPERIMENTAL

KickStart30 is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.

Behavioral: Wellness Element 1: ExerciseBehavioral: Wellness Element 2: MindfulnessBehavioral: Wellness Element 3 - Sleep HygieneBehavioral: Wellness Element 4 - Social ConnectednessBehavioral: Wellness Element 5 - NutritionBehavioral: Wellness Element 6 - Wellness ExercisesBehavioral: Wellness Element 7 - Motivational Messages

Interventions

Daily wellness element focusing on Exercise; adherence documented online daily

Wellness Intervention

Daily wellness element focusing on Mindfulness Meditation; adherence documented online daily

Wellness Intervention

Daily wellness element focusing on sleep hygiene; adherence documented online daily

Wellness Intervention

Daily wellness element focusing on social connectedness; adherence documented online daily

Wellness Intervention

Daily wellness element focusing on nutrition; adherence documented online daily

Wellness Intervention

Daily wellness workbook exercises focusing on improving mental wellness; adherence documented online daily

Wellness Intervention

Daily motivational emails offering information on one of the 5 wellness elements each day (Exercise, Mindfulness Meditation, Sleep, Social Connectedness, and Nutrition)

Wellness Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Licensed nurse in Texas Enrolled in TPAPN services/programs English-speaking Access to a reliable Internet-enabled computer Basic computer skills

You may not qualify if:

  • Acutely suicidal and/or actively psychotic Non-English speaking Participants that are pregnant or plan to get pregnant during the next 30- days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78701, United States

Location

Related Publications (3)

  • Jarrad R, Hammad S, Shawashi T, Mahmoud N. Compassion fatigue and substance use among nurses. Ann Gen Psychiatry. 2018 Mar 13;17:13. doi: 10.1186/s12991-018-0183-5. eCollection 2018.

  • Mumba MN. Employment implications of nurses going through peer assistance programs for substance use disorders. Arch Psychiatr Nurs. 2018 Aug;32(4):561-567. doi: 10.1016/j.apnu.2018.03.001. Epub 2018 Mar 7.

  • Rolin D, Fox I, Jain R, Cole SP, Tran C, Jain S. Wellness Interventions in Psychiatrically Ill Patients: Impact of WILD 5 Wellness, a Five-Domain Mental Health Wellness Intervention on Depression, Anxiety, and Wellness. J Am Psychiatr Nurses Assoc. 2020 Sep/Oct;26(5):493-502. doi: 10.1177/1078390319886883. Epub 2019 Nov 18.

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Saundra M Jain, PsyD, LPC

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 7, 2020

Study Start

September 1, 2020

Primary Completion

July 5, 2022

Study Completion

July 14, 2022

Last Updated

July 18, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations