Chronic PainKickStart30NCT03993548
KickStart30: A 30-Day Intervention for Patients With Rheumatoid Arthritis (RA)
A study testing Wellness Element 1 - Exercise, Wellness Element 2 - Mindfulness and Wellness Element 3 - Sleep Hygiene in people with Chronic Pain and Stress, 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 patients with Rheumatoid Arthritis (RA) taking a biologic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Stress, Psychological
- 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
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2019to 12 Mar 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with Rheumatoid Arthritis (RA) by a Rheumatologist
- Currently taking a biologic and/or a JaK inhibitor for the treatment of RA, including one or more of the following: Orencia (intravenous infusion or subcutaneous injection), Humira (subcutaneous injection), Kineret (subcutaneous injection), Cimzia (subcutaneous injection), Enbrel (subcutaneous injection), Simponi (subcutaneous injection), Simponi Aria (intravenous infusion), Remicade (intravenous infusion), Kevzara (subcutaneous injection), Rituxan (intravenous infusion), Actemra (intravenous infusion or subcutaneous injection), Olumiant (oral administration), Xeljanz (oral administration)
- Interested in improving overall wellness
- Not pregnant and no plans to get pregnant during the 30-day study
- English-speaking
- Must have access to a reliable Internet-enabled computer
- Must possess basic computer skills
Who cannot join
- Has not been diagnosed with RA by a Rheumatologist
- Not currently taking a biologic or a JAK inhibitor for the treatment of RA
- Not interested in improving overall wellness
- Pregnant or plans to get pregnant during the 30-day study
- Does not speak English
- Does not have access to a reliable, Internet-enabled computer
- Reports a lack of basic computer skills
- Acutely suicidal and/or actively psychotic
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 patients with Rheumatoid Arthritis (RA) taking a biologic. 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
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 Rheumatoid Arthritis taking a biologic or a JAK inhibitor.
Traditionally mental health and other specialties like rheumatology have focused primarily on the diagnosis and treatment of illness rather than incorporating wellness as an essential element of treatment. Those in the helping professions are trained to diagnose health problems with treatment typically focusing on symptom reduction. More recently, mental health and other healthcare specialties like rheumatology have initiated a conversation and subsequent research focusing on the importance of integrating elements of wellness into treatment. Rather than focusing solely on symptom reduction, some providers have begun incorporating elements of wellness promotion into treatment with favorable results.
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 patients with RA. 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 individuals, ages 18 and older, interested in improving their overall wellness and that self-identify as having Rheumatoid Arthritis and taking a biologic or a JAK inhibitor. Each participant will be engaged in the program for 30 days. To determine a participant's eligibility, study personnel will conduct a preliminary screening/orientation telephone interview. If the participant is determined to be eligible for the study based on the preliminary screening/orientation phone interview, 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. The consent form outlines the purpose and design of the study, data to be collected, confidentiality standards, alternatives to participation, and contact information for research personnel. 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 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, happiness, enthusiasm, resilience, and optimism in patients with RA.
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
- Chronic Pain, Stress, Psychological, Healthy, Rheumatoid Arthritis
- 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
- Wellness, Mental Wellness, Well-Being
- Medical subject headings
- Chronic Pain, Arthritis, Rheumatoid
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 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 Mindful Attention Awareness Scale (MAAS)
The MAAS is a 15-item scale designed to assess a core characteristic of dispositional mindfulness. Scores range from 15-90 (Higher scores = Higher levels of mindfulness).
Measured: 0, and 30 days
Change in Sleep Condition Indicator (SCI)
The SCI is a brief 8-item screening tool to evaluate insomnia disorder. Scores range from 0-32 (Lower scores = Greater sleep problems).
Measured: 0, and 30 days
Change in Social Connectedness Scale (SCS)
The SCS is an 8-item questionnaire that assesses the degree to which people feel connected to others in their social environment. Scores range from 8 to 48. (Higher scores = More connectedness to others).
Measured: 0, and 30 days
Change in Eating and Appraisal Due to Emotions and Stress (EADES)
The EADES is a 24-item sub-scale used to measure stress-related eating. Scores range from 24-120 (Lower scores = Greater emotion and stress-related eating).
Measured: 0, and 30 days
Change in Brief Pain Inventory (BPI)
The BPI is an 8-item scale that assesses pain. Scores range from 0-10. (0 = No pain and 10 = Pain as bad as you can imagine).
Measured: 0, and 30 days
Change in Sheehan Disability Scale (SDS)
The SDS is a 3-item measurement tool for assessing functional impairment in three inter-related domains: work/school, social, and family life. Scores range from 0-10 (Higher scores = Higher levels of functional impairment).
Measured: 0, and 30 days
Change in Cognitive and Physical Functioning Questionnaire (CPFQ)
The CPFQ is a brief 7-item scale designed to assess cognitive and physical functioning. Scores range from 7-42 (Lower scores = Higher levels of cognitive and physical functioning).
Measured: 0, and 30 days
Change in HERO Wellness Scale
The HERO Wellness Scale is a brief 5-item scale designed to measure four wellness traits plus perceived mental wellness. Scores range from 0-50 (Lower scores = Lower levels of mental wellness).
Measured: 0, and 30 days
Post-Program Participant Questionnaire
A brief 6 question post study survey that captures participants' opinions about KickStart30.
Measured: 0, and 30 days
Change in Health Assessment Questionnaire-II (HAQ-II)
The HAQ-II is a ten-item self-report questionnaire for assessing functional status in individuals with rheumatic disease. Scores range from 0-3.0 (Higher scores = Worse functioning and greater disability).
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 posted20 Jun 2019
- Study start17 Jun 2019
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saundra Jain, University of Texas at Austin
- Investigators
- Saundra M Jain, PsyD, LPC, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993548
- Sponsor's protocol ID
- 2018-10-0095
- Acronym
- KickStart30
- Status last verified
- Mar 2020
- First submitted
- 18 Jun 2019
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KickStart30: A 30-Day Intervention for Patients With Rheumatoid Arthritis (RA)
- ClinicalTrials.gov ID
- NCT03993548
- Acronym / sponsor ID
- KickStart30 / 2018-10-0095
- Conditions
- Chronic Pain, Stress, Psychological, Healthy, Rheumatoid Arthritis
- Keywords
- Wellness, Mental Wellness, Well-Being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 20 Jun 2019 (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 patients with Rheumatoid Arthritis (RA) taking a biologic. 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
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 Rheumatoid Arthritis taking a biologic or a JAK inhibitor.
Traditionally mental health and other specialties like rheumatology have focused primarily on the diagnosis and treatment of illness rather than incorporating wellness as an essential element of treatment. Those in the helping professions are trained to diagnose health problems with treatment typically focusing on symptom reduction. More recently, mental health and other healthcare specialties like rheumatology have initiated a conversation and subsequent research focusing on the importance of integrating elements of wellness into treatment. Rather than focusing solely on symptom reduction, some providers have begun incorporating elements of wellness promotion into treatment with favorable results.
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 patients with RA. 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 individuals, ages 18 and older, interested in improving their overall wellness and that self-identify as having Rheumatoid Arthritis and taking a biologic or a JAK inhibitor. Each participant will be engaged in the program for 30 days. To determine a participant's eligibility, study personnel will conduct a preliminary screening/orientation telephone interview. If the participant is determined to be eligible for the study based on the preliminary screening/orientation phone interview, 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. The consent form outlines the purpose and design of the study, data to be collected, confidentiality standards, alternatives to participation, and contact information for research personnel. 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 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, happiness, enthusiasm, resilience, and optimism in patients with RA.
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
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed with Rheumatoid Arthritis (RA) by a Rheumatologist
- Currently taking a biologic and/or a JaK inhibitor for the treatment of RA, including one or more of the following: Orencia (intravenous infusion or subcutaneous injection), Humira (subcutaneous injection), Kineret (subcutaneous injection), Cimzia (subcutaneous injection), Enbrel (subcutaneous injection), Simponi (subcutaneous injection), Simponi Aria (intravenous infusion), Remicade (intravenous infusion), Kevzara (subcutaneous injection), Rituxan (intravenous infusion), Actemra (intravenous infusion or subcutaneous injection), Olumiant (oral administration), Xeljanz (oral administration)
- Interested in improving overall wellness
- Not pregnant and no plans to get pregnant during the 30-day study
- English-speaking
Key exclusion criteria (8 listed)
- Has not been diagnosed with RA by a Rheumatologist
- Not currently taking a biologic or a JAK inhibitor for the treatment of RA
- Not interested in improving overall wellness
- Pregnant or plans to get pregnant during the 30-day study
- Does not speak English
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 Patient Health Questionnaire-9 (PHQ-9)
Time frame: 0, and 30 days
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).
Change in Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 0, and 30 days
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).
Change in World Health Organization Well-Being Index (WHO-5)
Time frame: 0, and 30 days
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).
Change in Mindful Attention Awareness Scale (MAAS)
Time frame: 0, and 30 days
The MAAS is a 15-item scale designed to assess a core characteristic of dispositional mindfulness. Scores range from 15-90 (Higher scores = Higher levels of mindfulness).
Change in Sleep Condition Indicator (SCI)
Time frame: 0, and 30 days
The SCI is a brief 8-item screening tool to evaluate insomnia disorder. Scores range from 0-32 (Lower scores = Greater sleep problems).
Change in Social Connectedness Scale (SCS)
Time frame: 0, and 30 days
The SCS is an 8-item questionnaire that assesses the degree to which people feel connected to others in their social environment. Scores range from 8 to 48. (Higher scores = More connectedness to others).
Change in Eating and Appraisal Due to Emotions and Stress (EADES)
Time frame: 0, and 30 days
The EADES is a 24-item sub-scale used to measure stress-related eating. Scores range from 24-120 (Lower scores = Greater emotion and stress-related eating).
Change in Brief Pain Inventory (BPI)
Time frame: 0, and 30 days
The BPI is an 8-item scale that assesses pain. Scores range from 0-10. (0 = No pain and 10 = Pain as bad as you can imagine).
Change in Sheehan Disability Scale (SDS)
Time frame: 0, and 30 days
The SDS is a 3-item measurement tool for assessing functional impairment in three inter-related domains: work/school, social, and family life. Scores range from 0-10 (Higher scores = Higher levels of functional impairment).
Change in Cognitive and Physical Functioning Questionnaire (CPFQ)
Time frame: 0, and 30 days
The CPFQ is a brief 7-item scale designed to assess cognitive and physical functioning. Scores range from 7-42 (Lower scores = Higher levels of cognitive and physical functioning).
Change in HERO Wellness Scale
Time frame: 0, and 30 days
The HERO Wellness Scale is a brief 5-item scale designed to measure four wellness traits plus perceived mental wellness. Scores range from 0-50 (Lower scores = Lower levels of mental wellness).
Post-Program Participant Questionnaire
Time frame: 0, and 30 days
A brief 6 question post study survey that captures participants' opinions about KickStart30.
Change in Health Assessment Questionnaire-II (HAQ-II)
Time frame: 0, and 30 days
The HAQ-II is a ten-item self-report questionnaire for assessing functional status in individuals with rheumatic disease. Scores range from 0-3.0 (Higher scores = Worse functioning and greater disability).
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 17 Apr 2020.
- 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 Chronic Pain and Stress, 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 7 inclusion and 8 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 17 Apr 2020. 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 Patient Health Questionnaire-9 (PHQ-9) (time frame: 0, and 30 days). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2020; AzTrials last refreshed its copy on 6 Nov 2026.