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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| Wellness Intervention | Experimental | KickStart30 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.
Change in HERO Wellness Scale
Brief scale that measures 4 wellness traits plus perceived mental wellness
Measured: 0, and 30 days
Secondary outcomes (12)
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
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
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
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
Change in Patient Safety Screener (PSS-3)
a 3-item screening tool for suicidality
Measured: 0, and 30 days
Change in the Mindful Attention Awareness Scale (MAAS),
a measure to assess mindfulness
Measured: 0, and 30 days
Change in the Sleep Condition Indicator (SCI),
a brief scale that assesses for insomnia disorder
Measured: 0, and 30 days
Change in the Social Connectedness Scale (SCS),
a brief scale that assesses social connectedness
Measured: 0, and 30 days
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
Change in Brief Pain Inventory (BPI)
a measurement tool for assessing clinical pain.
Measured: 0, and 30 days
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
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.
- First posted7 Jul 2020
- Study start1 Sep 2020
- Primary completion5 Jul 2022
- Study completion14 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saundra M Jain, PsyD, LPC, Principal investigator, University of Texas at Austin
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 29563960Mumba 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 30029748Rolin 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KickStart30: A 30-Day Nursing Wellness Initiative
- ClinicalTrials.gov ID
- NCT04459728
- Acronym / sponsor ID
- 2020-05-0084
- Conditions
- Substance Use
- Keywords
- Substance Use, Registered Nurses, Wellness Programs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 5 Jul 2022 (actual)
- Study completion
- 14 Jul 2022 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wellness Intervention | Experimental | 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 MessagesKickStart30 is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Licensed nurse in Texas Enrolled in TPAPN services/programs English-speaking Access to a reliable Internet-enabled computer Basic computer skills
Key exclusion criteria (1 listed)
- Acutely suicidal and/or actively psychotic Non-English speaking Participants that are pregnant or plan to get pregnant during the next 30- days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wellness Element 1: ExerciseDaily wellness element focusing on Exercise; adherence documented online daily | Behavioural | Wellness Intervention |
| Wellness Element 2: MindfulnessDaily wellness element focusing on Mindfulness Meditation; adherence documented online daily | Behavioural | Wellness Intervention |
| Wellness Element 3 - Sleep HygieneDaily wellness element focusing on sleep hygiene; adherence documented online daily | Behavioural | Wellness Intervention |
| Wellness Element 4 - Social ConnectednessDaily wellness element focusing on social connectedness; adherence documented online daily | Behavioural | Wellness Intervention |
| Wellness Element 5 - NutritionDaily wellness element focusing on nutrition; adherence documented online daily | Behavioural | Wellness Intervention |
| Wellness Element 6 - Wellness ExercisesDaily wellness workbook exercises focusing on improving mental wellness; adherence documented online daily | Behavioural | Wellness Intervention |
| Wellness Element 7 - Motivational MessagesDaily motivational emails offering information on one of the 5 wellness elements each day (Exercise, Mindfulness Meditation, Sleep, Social Connectedness, and Nutrition) | Behavioural | Wellness Intervention |
Primary outcome
Change in HERO Wellness Scale
Time frame: 0, and 30 days
Brief scale that measures 4 wellness traits plus perceived mental wellness
12 secondary outcomes
Change in Patient Health Questionnaire-9 (PHQ-9)
Time frame: 0, and 30 days
Change in Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 0, and 30 days
Change in World Health Organization Well-Being Index (WHO-5)
Time frame: 0, and 30 days
Change in the Short Inventory of Problems Revised (SIP-R),
Time frame: 0, and 30 days
Change in Patient Safety Screener (PSS-3)
Time frame: 0, and 30 days
Change in the Mindful Attention Awareness Scale (MAAS),
Time frame: 0, and 30 days
Change in the Sleep Condition Indicator (SCI),
Time frame: 0, and 30 days
Change in the Social Connectedness Scale (SCS),
Time frame: 0, and 30 days
Change in the Eating and Appraisal Due to Emotions and Stress (EADES)
Time frame: 0, and 30 day
Change in Brief Pain Inventory (BPI)
Time frame: 0, and 30 days
Change in the Sheehan Disability Scale (SDS),
Time frame: 0, and 30 days
Change in the Cognitive and Physical Functioning Questionnaire (CPFQ)
Time frame: 0, and 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Results publication: PubMed 29563960Jarrad 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.
- Results publication: PubMed 30029748Mumba 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.
- Results publication: PubMed 31738111Rolin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saundra M Jain, PsyD, LPC principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
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.