<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04459728</url>
  </required_header>
  <id_info>
    <org_study_id>2020-05-0084</org_study_id>
    <nct_id>NCT04459728</nct_id>
  </id_info>
  <brief_title>KickStart30: A 30-Day Nursing Wellness Initiative</brief_title>
  <official_title>KickStart30: A 30-Day Nursing Wellness Initiative</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas at Austin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas at Austin</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study explores the efficacy and feasibility of a self-management wellness intervention&#xD;
      that is integrated, prescriptive, and trackable in a population of registered nurses in the&#xD;
      state of Texas enrolled in the TExas Peer Assistance Program for Nurses (TPAPN). This 30-day&#xD;
      wellness intervention (called &quot;KickStart30&quot;) combines five wellness elements:&#xD;
      exercise,mindfulness, sleep, social connectedness, and nutrition. Additionally, the program&#xD;
      requires that participants implement 5 wellness interventions daily for the 30-day study,&#xD;
      document daily online adherence, complete daily HERO (happiness, enthusiasm, resilience, and&#xD;
      optimism) exercises to improve mental wellness, and complete online program forms before and&#xD;
      after the 30-day intervention. Participants are assessed pre- and post-intervention to&#xD;
      determine whether the intervention promotes wellness behavior changes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      TPAPN is a voluntary program funded by the Texas Board of Nursing that provides early&#xD;
      identification, support, monitoring, and accountability to Texas nurses who have an&#xD;
      identified substance use and/or mental health condition or related incident. The goal of&#xD;
      TPAPN is to help the nurse return to safe nursing practice. Currently, TPAPN does not offer a&#xD;
      wellness intervention as part of their services. The purpose of this study is to explore the&#xD;
      efficacy and feasibility of a self-management wellness intervention that is integrated,&#xD;
      prescriptive, and trackable in a population of Texas nurses referred to a peer assistance&#xD;
      monitoring program for an identified substance use and/or mental health condition or related&#xD;
      incident. It is expected that this 30-day integrated, prescriptive, and trackable wellness&#xD;
      intervention (combining five wellness elements including exercise, mindfulness, sleep, social&#xD;
      connectedness, and nutrition) will be found to be an efficacious program for those with&#xD;
      nurses enrolled in TPAPN.&#xD;
&#xD;
      Nurses are more susceptible to maladaptive coping behaviors, including turning to substance&#xD;
      use or abuse, due to workplace stressors (Jarrad et al., 2018). Participating in a nursing&#xD;
      monitoring program may increase stress in an already highly stressful profession; monitoring&#xD;
      requirements alone can cause feelings of embarrassment and guilt (Mumba, 2018). It is the&#xD;
      hope that adding the KickStart30 program, previously studied in a population with mental&#xD;
      health issues (Rolin et al., 2019; NCT03993548) to the current offerings of TPAPN will result&#xD;
      in the nurse replacing negative coping mechanisms with the positive coping mechanism,&#xD;
      increasing long-term recovery and decreasing the likelihood of making an error in the&#xD;
      workplace.&#xD;
&#xD;
      To the best of our knowledge, even though there is abundant research supporting each of the&#xD;
      KickStart30 elements (exercise, mindfulness, sleep, social connectedness, and nutrition)&#xD;
      individually, there is no research exploring the effectiveness of an integrated,&#xD;
      prescriptive, and trackable wellness intervention combining these five elements specific to a&#xD;
      cohort of nurses. Therefore, this work will be unique in that it will collect both objective&#xD;
      and subjective data to assess the feasibility and effectiveness of this type of wellness&#xD;
      intervention. It will lend support to the growing body of research on the efficacy of&#xD;
      wellness interventions for a variety of different health conditions, as well as a&#xD;
      community-based population. Finally, it is hoped that positive results will yield increased&#xD;
      access to and utilization of this type of intervention, thereby improving public health.&#xD;
&#xD;
      The recruitment period will be open for 12 months to obtain a maximum of 50 participants. The&#xD;
      study population will be nurses, ages 18 and older, interested in improving their overall&#xD;
      wellness as part of the TPAPN program. Potential participants will be recruited via TPAPN&#xD;
      Case Managers, Peer Support Partners, and Program Director who will provide recruitment&#xD;
      flyers to potential participants. The study flyer will be posted to the TPAPN website as well&#xD;
      as a informational video for potential participants to view. Interested individuals will be&#xD;
      provided a toll-free phone number belonging to study personnel, which will be monitored daily&#xD;
      Monday through Friday. Study personnel will reply to interested parties with a verbal&#xD;
      screening/orientation call to determine eligibility. If the participant meets study criteria,&#xD;
      the participant will be emailed a link to the online consent form, registration form, and&#xD;
      program forms. Participants will have the option to download a PDF of their signed consent&#xD;
      form for their records at the time of signing/completion. Study personnel will collect the&#xD;
      participant's email address, physical mailing address, and assign the participant a unique&#xD;
      identification code based on the order in which the participant was screened&#xD;
&#xD;
      Study personnel will mail each participant a KickStart30 Workbook within one day of emailing&#xD;
      participants their unique identification codes. Participants will be instructed to document&#xD;
      adherence of their daily wellness practices and their daily HERO exercises online via&#xD;
      Qualtrics, an online survey software. Participants can document their daily adherence using&#xD;
      their computer and/or their smartphone as Qualtrics offers a mobile version of the&#xD;
      Participant Tracking Form. A copy of the Participant Tracking Form will also be available in&#xD;
      the KickStart30 Workbook so participants that prefer keeping a daily paper log can do so, and&#xD;
      they can then transfer their program adherence information to the online Participant Tracking&#xD;
      Form at their convenience throughout the program. The workbook will contain the participant's&#xD;
      personal identification code; no personal identification will appear in the workbook in order&#xD;
      to protect participant confidentiality. Participants will also receive daily motivational&#xD;
      emails from MailChimp, which will provide general information about one of the five wellness&#xD;
      elements and/or one of the HERO wellness traits, as well as encouragement to track their&#xD;
      participation on a daily basis, and encouragement to contact study personnel via email with&#xD;
      any questions and/or concerns.&#xD;
&#xD;
      Data capture will occur at two points: once prior to beginning the study and again at the end&#xD;
      of the 30-day study. Data will be collected online through program forms; all data will be&#xD;
      hosted on Qualtrics, an online survey software. Program Forms assess items including&#xD;
      depression, anxiety, wellbeing, mindfulness, sleep quality, social connectedness, emotional&#xD;
      eating, pain, disability, physical function, cognition, substance and alcohol use,&#xD;
      suicidality, happiness, enthusiasm, resilience, and optimism.&#xD;
&#xD;
      Descriptive statistics will be used to discuss pre- and post-intervention scores.&#xD;
&#xD;
      Differences between pretest and 30-day measures will be assessed with repeated measures&#xD;
      ANOVA, with a p value of less than 0.05 indicating statistical significance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">July 14, 2022</completion_date>
  <primary_completion_date type="Actual">July 5, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in HERO Wellness Scale</measure>
    <time_frame>0, and 30 days</time_frame>
    <description>Brief scale that measures 4 wellness traits plus perceived mental wellness</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Health Questionnaire-9 (PHQ-9)</measure>
    <time_frame>0, and 30 days</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Generalized Anxiety Disorder-7 (GAD-7)</measure>
    <time_frame>0, and 30 days</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in World Health Organization Well-Being Index (WHO-5)</measure>
    <time_frame>0, and 30 days</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Short Inventory of Problems Revised (SIP-R),</measure>
    <time_frame>0, and 30 days</time_frame>
    <description>a 17-item inventory of adverse consequences associated with drug and alcohol use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Safety Screener (PSS-3)</measure>
    <time_frame>0, and 30 days</time_frame>
    <description>a 3-item screening tool for suicidality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Mindful Attention Awareness Scale (MAAS),</measure>
    <time_frame>0, and 30 days</time_frame>
    <description>a measure to assess mindfulness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Sleep Condition Indicator (SCI),</measure>
    <time_frame>0, and 30 days</time_frame>
    <description>a brief scale that assesses for insomnia disorder</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Social Connectedness Scale (SCS),</measure>
    <time_frame>0, and 30 days</time_frame>
    <description>a brief scale that assesses social connectedness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Eating and Appraisal Due to Emotions and Stress (EADES)</measure>
    <time_frame>0, and 30 day</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Brief Pain Inventory (BPI)</measure>
    <time_frame>0, and 30 days</time_frame>
    <description>a measurement tool for assessing clinical pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Sheehan Disability Scale (SDS),</measure>
    <time_frame>0, and 30 days</time_frame>
    <description>a measurement tool for assessing functional impairment in three interrelated domains (work/school, social and family life.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Cognitive and Physical Functioning Questionnaire (CPFQ)</measure>
    <time_frame>0, and 30 days</time_frame>
    <description>a brief scale that measures cognitive and executive dysfunction</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Substance Use</condition>
  <arm_group>
    <arm_group_label>Wellness Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>KickStart30 is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Wellness Element 1: Exercise</intervention_name>
    <description>Daily wellness element focusing on Exercise; adherence documented online daily</description>
    <arm_group_label>Wellness Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Wellness Element 2: Mindfulness</intervention_name>
    <description>Daily wellness element focusing on Mindfulness Meditation; adherence documented online daily</description>
    <arm_group_label>Wellness Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Wellness Element 3 - Sleep Hygiene</intervention_name>
    <description>Daily wellness element focusing on sleep hygiene; adherence documented online daily</description>
    <arm_group_label>Wellness Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Wellness Element 4 - Social Connectedness</intervention_name>
    <description>Daily wellness element focusing on social connectedness; adherence documented online daily</description>
    <arm_group_label>Wellness Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Wellness Element 5 - Nutrition</intervention_name>
    <description>Daily wellness element focusing on nutrition; adherence documented online daily</description>
    <arm_group_label>Wellness Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Wellness Element 6 - Wellness Exercises</intervention_name>
    <description>Daily wellness workbook exercises focusing on improving mental wellness; adherence documented online daily</description>
    <arm_group_label>Wellness Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Wellness Element 7 - Motivational Messages</intervention_name>
    <description>Daily motivational emails offering information on one of the 5 wellness elements each day (Exercise, Mindfulness Meditation, Sleep, Social Connectedness, and Nutrition)</description>
    <arm_group_label>Wellness Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Licensed nurse in Texas Enrolled in TPAPN services/programs English-speaking Access to a&#xD;
        reliable Internet-enabled computer Basic computer skills&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Acutely suicidal and/or actively psychotic Non-English speaking Participants that are&#xD;
        pregnant or plan to get pregnant during the next 30- days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Saundra M Jain, PsyD, LPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas at Austin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas at Austin</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>29563960</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>30029748</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>31738111</PMID>
  </results_reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 14, 2022</last_update_submitted>
  <last_update_submitted_qc>July 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Substance Use, Registered Nurses, Wellness Programs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04459728
org study id: 2020-05-0084
nct id: NCT04459728
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in HERO Wellness Scale
time frame: 0, and 30 days
description: Brief scale that measures 4 wellness traits plus perceived mental wellness
measure: Change in Patient Health Questionnaire-9 (PHQ-9)
time frame: 0, and 30 days
description: 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)
measure: Change in Generalized Anxiety Disorder-7 (GAD-7)
time frame: 0, and 30 days
description: 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).
measure: Change in World Health Organization Well-Being Index (WHO-5)
time frame: 0, and 30 days
description: 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)
measure: Change in the Short Inventory of Problems Revised (SIP-R),
time frame: 0, and 30 days
description: a 17-item inventory of adverse consequences associated with drug and alcohol use
measure: Change in Patient Safety Screener (PSS-3)
time frame: 0, and 30 days
description: a 3-item screening tool for suicidality
measure: Change in the Mindful Attention Awareness Scale (MAAS),
time frame: 0, and 30 days
description: a measure to assess mindfulness
measure: Change in the Sleep Condition Indicator (SCI),
time frame: 0, and 30 days
description: a brief scale that assesses for insomnia disorder
measure: Change in the Social Connectedness Scale (SCS),
time frame: 0, and 30 days
description: a brief scale that assesses social connectedness
measure: Change in the Eating and Appraisal Due to Emotions and Stress (EADES)
time frame: 0, and 30 day
description: 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.
measure: Change in Brief Pain Inventory (BPI)
time frame: 0, and 30 days
description: a measurement tool for assessing clinical pain.
measure: Change in the Sheehan Disability Scale (SDS),
time frame: 0, and 30 days
description: a measurement tool for assessing functional impairment in three interrelated domains (work/school, social and family life.)
measure: Change in the Cognitive and Physical Functioning Questionnaire (CPFQ)
time frame: 0, and 30 days
description: a brief scale that measures cognitive and executive dysfunction
arm group label: Wellness Intervention
arm group type: Experimental
description: KickStart30 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: Wellness Element 1: Exercise
description: Daily wellness element focusing on Exercise; adherence documented online daily
arm group label: Wellness Intervention
intervention type: Behavioral
intervention name: Wellness Element 2: Mindfulness
description: Daily wellness element focusing on Mindfulness Meditation; adherence documented online daily
arm group label: Wellness Intervention
intervention type: Behavioral
intervention name: Wellness Element 3 - Sleep Hygiene
description: Daily wellness element focusing on sleep hygiene; adherence documented online daily
arm group label: Wellness Intervention
intervention type: Behavioral
intervention name: Wellness Element 4 - Social Connectedness
description: Daily wellness element focusing on social connectedness; adherence documented online daily
arm group label: Wellness Intervention
intervention type: Behavioral
intervention name: Wellness Element 5 - Nutrition
description: Daily wellness element focusing on nutrition; adherence documented online daily
arm group label: Wellness Intervention
intervention type: Behavioral
intervention name: Wellness Element 6 - Wellness Exercises
description: Daily wellness workbook exercises focusing on improving mental wellness; adherence documented online daily
arm group label: Wellness Intervention
intervention type: Behavioral
intervention name: Wellness Element 7 - Motivational Messages
description: Daily motivational emails offering information on one of the 5 wellness elements each day (Exercise, Mindfulness Meditation, Sleep, Social Connectedness, and Nutrition)
arm group label: Wellness Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Saundra M Jain, PsyD, LPC
role: Principal Investigator
affiliation: University of Texas at Austin
facility: 
country: United States
citation: 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.
PMID: 29563960
citation: 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.
PMID: 30029748
citation: 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.
PMID: 31738111
responsible party type: Sponsor
mesh term: Substance-Related Disorders
sharing ipd: No