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Substance UseNCT04459728

KickStart30: A 30-Day Nursing Wellness Initiative

A study testing Wellness Element 1: Exercise, Wellness Element 2: Mindfulness and Wellness Element 3 - Sleep Hygiene in people with Substance Use, run by University of Texas at Austin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Substance Use
What is being tested?
Wellness Element 1: Exercise, Wellness Element 2: Mindfulness and Wellness Element 3 - Sleep Hygiene
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
1 Sep 2020to 14 Jul 2022
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Texas at Austin

    Austin, Texas, 78701

Other trials in United States

About this study

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.

Read the detailed description

TPAPN is a voluntary program funded by the Texas Board of Nursing that provides early identification, support, monitoring, and accountability to Texas nurses who have an identified substance use and/or mental health condition or related incident. The goal of TPAPN is to help the nurse return to safe nursing practice. Currently, TPAPN does not offer a wellness intervention as part of their services. The purpose of this study is to explore the efficacy and feasibility of a self-management wellness intervention that is integrated, prescriptive, and trackable in a population of Texas nurses referred to a peer assistance monitoring program for an identified substance use and/or mental health condition or related incident. It is expected that this 30-day integrated, prescriptive, and trackable wellness intervention (combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition) will be found to be an efficacious program for those with nurses enrolled in TPAPN.

Nurses are more susceptible to maladaptive coping behaviors, including turning to substance use or abuse, due to workplace stressors (Jarrad et al., 2018). Participating in a nursing monitoring program may increase stress in an already highly stressful profession; monitoring requirements alone can cause feelings of embarrassment and guilt (Mumba, 2018). It is the hope that adding the KickStart30 program, previously studied in a population with mental health issues (Rolin et al., 2019; NCT03993548) to the current offerings of TPAPN will result in the nurse replacing negative coping mechanisms with the positive coping mechanism, increasing long-term recovery and decreasing the likelihood of making an error in the workplace.

To the best of our knowledge, even though there is abundant research supporting each of the KickStart30 elements (exercise, mindfulness, sleep, social connectedness, and nutrition) individually, there is no research exploring the effectiveness of an integrated, prescriptive, and trackable wellness intervention combining these five elements specific to a cohort of nurses. Therefore, this work will be unique in that it will collect both objective and subjective data to assess the feasibility and effectiveness of this type of wellness intervention. It will lend support to the growing body of research on the efficacy of wellness interventions for a variety of different health conditions, as well as a community-based population. Finally, it is hoped that positive results will yield increased access to and utilization of this type of intervention, thereby improving public health.

The recruitment period will be open for 12 months to obtain a maximum of 50 participants. The study population will be nurses, ages 18 and older, interested in improving their overall wellness as part of the TPAPN program. Potential participants will be recruited via TPAPN Case Managers, Peer Support Partners, and Program Director who will provide recruitment flyers to potential participants. The study flyer will be posted to the TPAPN website as well as a informational video for potential participants to view. Interested individuals will be provided a toll-free phone number belonging to study personnel, which will be monitored daily Monday through Friday. Study personnel will reply to interested parties with a verbal screening/orientation call to determine eligibility. If the participant meets study criteria, the participant will be emailed a link to the online consent form, registration form, and program forms. Participants will have the option to download a PDF of their signed consent form for their records at the time of signing/completion. Study personnel will collect the participant's email address, physical mailing address, and assign the participant a unique identification code based on the order in which the participant was screened

Study personnel will mail each participant a KickStart30 Workbook within one day of emailing participants their unique identification codes. Participants will be instructed to document adherence of their daily wellness practices and their daily HERO 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 KickStart30 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 at their convenience 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. Participants will also receive daily motivational emails from MailChimp, which will provide general information about one of the five wellness elements and/or one of the HERO wellness traits, 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.

Data capture will occur at two points: once prior to beginning the study and again at the end of the 30-day study. Data will be collected online through program forms; all data will be hosted on Qualtrics, an online survey software. Program Forms assess items including depression, anxiety, wellbeing, mindfulness, sleep quality, social connectedness, emotional eating, pain, disability, physical function, cognition, substance and alcohol use, suicidality, happiness, enthusiasm, resilience, and optimism.

Descriptive statistics will be used to discuss pre- and post-intervention scores.

Differences between pretest and 30-day measures will be assessed with repeated measures ANOVA, with a p value of less than 0.05 indicating statistical significance.

Conditions
Substance Use
Being tested
Wellness Element 1: Exercise, Wellness Element 2: Mindfulness, Wellness Element 3 - Sleep Hygiene, Wellness Element 4 - Social Connectedness, Wellness Element 5 - Nutrition
Keywords
Substance Use, Registered Nurses, Wellness Programs
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wellness Element 1: ExerciseBehavioural

    Daily wellness element focusing on Exercise; adherence documented online daily

  • Wellness Element 2: MindfulnessBehavioural

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

  • Wellness Element 3 - Sleep HygieneBehavioural

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

  • Wellness Element 4 - Social ConnectednessBehavioural

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

  • Wellness Element 5 - NutritionBehavioural

    Daily wellness element focusing on nutrition; adherence documented online daily

  • Wellness Element 6 - Wellness ExercisesBehavioural

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

  • Wellness Element 7 - Motivational MessagesBehavioural

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

Study groups in NCT04459728
Study groupRoleWhat they receive
Wellness InterventionExperimentalKickStart30 is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HERO Wellness Scale

    Brief scale that measures 4 wellness traits plus perceived mental wellness

    Measured: 0, and 30 days

Secondary outcomes (12)
  1. Change in Patient Health Questionnaire-9 (PHQ-9)

    The PHQ-9 is a nine-item depression self-report questionnaire for screening and measurement of severity of major depression. Scores range from 0-27 (lower scores = less depression)

    Measured: 0, and 30 days

  2. Change in Generalized Anxiety Disorder-7 (GAD-7)

    The GAD-7 is a seven-item self-report questionnaire for screening and measurement of severity of generalized anxiety disorder. Scores range from 0-21 (Lower scores = Less anxiety).

    Measured: 0, and 30 days

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

    The WHO-5 Well-Being Index is a five-item self-report questionnaire covering 5 areas: positive mood, vitality, and general interests. Scores range from 0-25 (Higher scores = Higher levels of well-being)

    Measured: 0, and 30 days

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

    a 17-item inventory of adverse consequences associated with drug and alcohol use

    Measured: 0, and 30 days

  5. Change in Patient Safety Screener (PSS-3)

    a 3-item screening tool for suicidality

    Measured: 0, and 30 days

  6. Change in the Mindful Attention Awareness Scale (MAAS),

    a measure to assess mindfulness

    Measured: 0, and 30 days

  7. Change in the Sleep Condition Indicator (SCI),

    a brief scale that assesses for insomnia disorder

    Measured: 0, and 30 days

  8. Change in the Social Connectedness Scale (SCS),

    a brief scale that assesses social connectedness

    Measured: 0, and 30 days

  9. Change in the Eating and Appraisal Due to Emotions and Stress (EADES)

    an assessment of utilizing stress and coping skills in relation to food and eating utilizing stress and coping skills in relation to food and eating.

    Measured: 0, and 30 day

  10. Change in Brief Pain Inventory (BPI)

    a measurement tool for assessing clinical pain.

    Measured: 0, and 30 days

  11. Change in the Sheehan Disability Scale (SDS),

    a measurement tool for assessing functional impairment in three interrelated domains (work/school, social and family life.)

    Measured: 0, and 30 days

  12. Change in the Cognitive and Physical Functioning Questionnaire (CPFQ)

    a brief scale that measures cognitive and executive dysfunction

    Measured: 0, and 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2020
  2. Study start1 Sep 2020
  3. Primary completion5 Jul 2022
  4. Study completion14 Jul 2022

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04459728
Sponsor's protocol ID
2020-05-0084
Status last verified
Jul 2022
First submitted
2 Jul 2020
Last updated
18 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29563960
  • 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.

    PubMed 30029748
  • 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.

    PubMed 31738111

Questions about this trial

What is this clinical trial studying?

A study testing Wellness Element 1: Exercise, Wellness Element 2: Mindfulness and Wellness Element 3 - Sleep Hygiene in people with Substance Use, run by University of Texas at Austin 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 1 inclusion and 1 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 18 Jul 2022. 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 HERO Wellness Scale (time frame: 0, and 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04459728, which also lists 3 linked publications.

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 18 Jul 2022.

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