Chronic PainNCT02918513
WILD 5 Wellness: A 90-Day Intervention (WILD = Wellness Interventions for Life's Demands)
A study testing Wellness Element 1 - Exercise, Wellness Element 2 - Mindfulness and Wellness Element 3 - Sleep Hygiene in people with Chronic Pain and Stress, Psychological, run by University of Texas at Austin at 1 site in United States.
Trial summary
The purpose of this study is to explore the efficacy and feasibility of an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition. 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, Healthy
- 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
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 13 Aug 2018
- 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
- Adults (18 years of age or older)
- English- speaking
- Access to a reliable Internet-enabled computer
- Possess basic computer skills
- Self-identify as having at least one of the health conditions listed on the online registration form or
- Self-identify as a community participant without a health condition.
Who cannot join
- Acutely suicidal and/or actively psychotic
- Non-English speaking
- Do not have access to an Internet-enabled computer
- Report a lack of basic computer skills
- Pregnant or plan to get pregnant during the next 90-days.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas at Austin School of Nursing
Austin, Texas, 78701
About this study
The purpose of this study is to explore the efficacy and feasibility of an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.
Read the detailed description
This study involves participating in a 90-day integrated, prescriptive, trackable wellness intervention, which includes five wellness elements: exercise, mindfulness, sleep, social connectedness, and nutrition.
The intervention is divided into three phases (each spanning 30-days): Phase 1 - 'Boot Camp', Phase 2 - Solidify, and Phase 3 - Sustain. Program requirements include: Implementing 5 wellness interventions daily for the first 30-days, at least 5 days for the next 30-days, and at least 3 days for the final 30-days, documenting daily online adherence, completing daily wellness exercises to improve mental wellness, and completing online program forms prior to beginning the program, at 30-days, and again at 90-days.
Once eligibility is confirmed via the initial orientation/screening call, study personnel will mail each participant a WILD 5 Wellness Workbook within one day of emailing participants their unique identification codes plus their start dates. Participants will be instructed to document adherence regarding their daily wellness practices and their daily wellness 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 WILD 5 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 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.
One day prior to a participant's start date, which will be set during the orientation/screening call, participants will receive an automated email from an online automated email service (MailChimp), with a reminder about their start date, and encouragement to contact study personnel with any questions or concerns.
Participants will also receive daily motivational emails from an online automated email service (MailChimp), which will provide general information about one of the five wellness elements and/or one of the wellness exercises, 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.
- Conditions
- Chronic Pain, Stress, Psychological, Healthy
- 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, Stress, Psychological
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 | WILD 5 Wellness 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)
A self-reported depression scale used to assess severity of depression.
Measured: 0, 30, and 90 days - Primary endpoint is 30 days
Change in Generalized Anxiety Disorder-7 (GAD-7)
A self-reported questionnaire used to assess anxiety symptoms.
Measured: 0, 30, and 90 days - Primary endpoint is 30 days
Change in World Health Organization-5 (WHO-5)
A brief scale that measures mental well- being.
Measured: 0, 30, and 90 days - Primary endpoint is 30 days
Change in The Mindful Attention Awareness Scale (MAAS)
A popular measure of mindfulness.
Measured: 0, 30, and 90 days - Primary endpoint is 30 days
Change in The Sleep Condition Indicator (SCI)
A brief scale that evaluates insomnia disorder.
Measured: 0, 30, and 90 days - Primary endpoint is 30 days
Change in The Social Connectedness Scale (SCS)
A brief scale that assesses the degree to which respondents feel connected to others.
Measured: 0, 30, and 90 days - Primary endpoint is 30 days
Change in Eating and Appraisal Due to Emotions and Stress (EADES)
A scale assessing how individuals cope with and appraise stress in relation to food and eating.
Measured: 0, 30, and 90 days - Primary endpoint is 30 days
Change in The Mediterranean-Dietary Approaches to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND)
A combination of the Mediterranean and DASH (Dietary Approaches to Stop Hypertension) diets shown to lower a person's risk of developing Alzheimer's disease.
Measured: 0, 30, and 90 - Primary endpoint is 30 days
Change in The Brief Pain Inventory (BPI)
A measurement tool for assessing clinical pain.
Measured: 0, 30, and 90 days - Primary endpoint is 30 days
Change in The Sheehan Disability Scale (SDS)
A measurement tool for assessing functional impairment in three inter-related domains: work/school, social and family life.
Measured: 0, 30, and 90 days - Primary endpoint is 30 days
Change in The Endicott Work Productivity Scale (EWPS)
A brief self-report questionnaire designed to obtain a sensitive measure of work productivity.
Measured: 0, 30, and 90 days - Primary endpoint is 30 days
Change in Cognitive and Physical Functioning Questionnaire (CPFQ)
A brief scale that measures cognitive and executive dysfunction.
Measured: 0, 30, and 90 days - Primary endpoint is 30 days
Change in The WILD 5 Wellness Scale (W5WS)
A brief scale designed specifically for this project to measure wellness.
Measured: 0, 30, and 90 days - Primary endpoint is 30 days
Change in The WILD 5 Wellness Effort Scale (W5ES)
A scale designed specifically for this project to measure weekly adherence with program elements.
Measured: 0, 30, and 90 days - Primary endpoint is 30 days
Change in The WILD 5 Wellness Elements Scale
A scale designed specifically for this project to measure elements of depression, anxiety, wellbeing, mindfulness, sleep quality, social connectedness, emotional eating, diet practices, pain, disability, work productivity, happiness, enthusiasm, resilience, and optimism.
Measured: 0, 30, and 90 days - Primary endpoint is 30 days
The Post-Program Participant Questionnaire
A brief post study survey that captures participants' opinions about WILD 5 Wellness: 90-Day Intervention, and subjective ranking of their overall wellness.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startOct 2016
- Primary completion12 Jun 2018
- Study completion13 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- 150 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
- NCT02918513
- Sponsor's protocol ID
- 2016-07-0021
- Status last verified
- Apr 2019
- First submitted
- 25 Jul 2016
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cooney GM, Dwan K, Greig CA, Lawlor DA, Rimer J, Waugh FR, McMurdo M, Mead GE. Exercise for depression. Cochrane Database Syst Rev. 2013 Sep 12;2013(9):CD004366. doi: 10.1002/14651858.CD004366.pub6.
PubMed 24026850Cruwys T, Dingle GA, Haslam C, Haslam SA, Jetten J, Morton TA. Social group memberships protect against future depression, alleviate depression symptoms and prevent depression relapse. Soc Sci Med. 2013 Dec;98:179-86. doi: 10.1016/j.socscimed.2013.09.013. Epub 2013 Sep 25.
PubMed 24331897Fardet A, Boirie Y. Associations between food and beverage groups and major diet-related chronic diseases: an exhaustive review of pooled/meta-analyses and systematic reviews. Nutr Rev. 2014 Dec;72(12):741-62. doi: 10.1111/nure.12153. Epub 2014 Nov 18.
PubMed 25406801Hui SK, Grandner MA. Associations between Poor Sleep Quality and Stages of Change of Multiple Health Behaviors among Participants of Employee Wellness Program. Prev Med Rep. 2015 Jan 1;2:292-299. doi: 10.1016/j.pmedr.2015.04.002.
PubMed 26046013Jeste DV, Palmer BW, Rettew DC, Boardman S. Positive psychiatry: its time has come. J Clin Psychiatry. 2015 Jun;76(6):675-83. doi: 10.4088/JCP.14nr09599.
PubMed 26132670Williams JM, Crane C, Barnhofer T, Brennan K, Duggan DS, Fennell MJ, Hackmann A, Krusche A, Muse K, Von Rohr IR, Shah D, Crane RS, Eames C, Jones M, Radford S, Silverton S, Sun Y, Weatherley-Jones E, Whitaker CJ, Russell D, Russell IT. Mindfulness-based cognitive therapy for preventing relapse in recurrent depression: a randomized dismantling trial. J Consult Clin Psychol. 2014 Apr;82(2):275-86. doi: 10.1037/a0035036. Epub 2013 Dec 2.
PubMed 24294837
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WILD 5 Wellness: A 90-Day Intervention (WILD = Wellness Interventions for Life's Demands)
- ClinicalTrials.gov ID
- NCT02918513
- Acronym / sponsor ID
- 2016-07-0021
- Conditions
- Chronic Pain, Stress, Psychological, Healthy
- Keywords
- Wellness, Mental Wellness, Well-Being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- 12 Jun 2018 (actual)
- Study completion
- 13 Aug 2018 (actual)
- First posted
- 29 Sep 2016 (estimated)
- 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.
The purpose of this study is to explore the efficacy and feasibility of an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.
Detailed description
This study involves participating in a 90-day integrated, prescriptive, trackable wellness intervention, which includes five wellness elements: exercise, mindfulness, sleep, social connectedness, and nutrition.
The intervention is divided into three phases (each spanning 30-days): Phase 1 - 'Boot Camp', Phase 2 - Solidify, and Phase 3 - Sustain. Program requirements include: Implementing 5 wellness interventions daily for the first 30-days, at least 5 days for the next 30-days, and at least 3 days for the final 30-days, documenting daily online adherence, completing daily wellness exercises to improve mental wellness, and completing online program forms prior to beginning the program, at 30-days, and again at 90-days.
Once eligibility is confirmed via the initial orientation/screening call, study personnel will mail each participant a WILD 5 Wellness Workbook within one day of emailing participants their unique identification codes plus their start dates. Participants will be instructed to document adherence regarding their daily wellness practices and their daily wellness 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 WILD 5 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 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.
One day prior to a participant's start date, which will be set during the orientation/screening call, participants will receive an automated email from an online automated email service (MailChimp), with a reminder about their start date, and encouragement to contact study personnel with any questions or concerns.
Participants will also receive daily motivational emails from an online automated email service (MailChimp), which will provide general information about one of the five wellness elements and/or one of the wellness exercises, 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.
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 MessagesWILD 5 Wellness 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 (6 listed)
- Adults (18 years of age or older)
- English- speaking
- Access to a reliable Internet-enabled computer
- Possess basic computer skills
- Self-identify as having at least one of the health conditions listed on the online registration form or
Key exclusion criteria (5 listed)
- Acutely suicidal and/or actively psychotic
- Non-English speaking
- Do not have access to an Internet-enabled computer
- Report a lack of basic computer skills
- Pregnant or plan to get pregnant during the next 90-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 - Exercise1. Daily wellness element focusing on Exercise; adherence documented online daily | Behavioural | Wellness Intervention |
| Wellness Element 2 - Mindfulness2. Daily wellness element focusing on Mindfulness Meditation; adherence documented online daily | Behavioural | Wellness Intervention |
| Wellness Element 3 - Sleep Hygiene3. Daily wellness element focusing on sleep hygiene; adherence documented online daily | Behavioural | Wellness Intervention |
| Wellness Element 4 - Social Connectedness4. Daily wellness element focusing on Social Connectedness; adherence documented online daily | Behavioural | Wellness Intervention |
| Wellness Element 5 - Nutrition5. Daily wellness element focusing on Nutrition; adherence documented online daily | Behavioural | Wellness Intervention |
| Wellness Element 6 - Wellness Exercises6. Daily wellness workbook exercises focusing on improving mental wellness; adherence documented online daily | Behavioural | Wellness Intervention |
| Wellness Element 7 - Motivational Messages7. Daily 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, 30, and 90 days - Primary endpoint is 30 days
A self-reported depression scale used to assess severity of depression.
Change in Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 0, 30, and 90 days - Primary endpoint is 30 days
A self-reported questionnaire used to assess anxiety symptoms.
Change in World Health Organization-5 (WHO-5)
Time frame: 0, 30, and 90 days - Primary endpoint is 30 days
A brief scale that measures mental well- being.
Change in The Mindful Attention Awareness Scale (MAAS)
Time frame: 0, 30, and 90 days - Primary endpoint is 30 days
A popular measure of mindfulness.
Change in The Sleep Condition Indicator (SCI)
Time frame: 0, 30, and 90 days - Primary endpoint is 30 days
A brief scale that evaluates insomnia disorder.
Change in The Social Connectedness Scale (SCS)
Time frame: 0, 30, and 90 days - Primary endpoint is 30 days
A brief scale that assesses the degree to which respondents feel connected to others.
Change in Eating and Appraisal Due to Emotions and Stress (EADES)
Time frame: 0, 30, and 90 days - Primary endpoint is 30 days
A scale assessing how individuals cope with and appraise stress in relation to food and eating.
Change in The Mediterranean-Dietary Approaches to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND)
Time frame: 0, 30, and 90 - Primary endpoint is 30 days
A combination of the Mediterranean and DASH (Dietary Approaches to Stop Hypertension) diets shown to lower a person's risk of developing Alzheimer's disease.
Change in The Brief Pain Inventory (BPI)
Time frame: 0, 30, and 90 days - Primary endpoint is 30 days
A measurement tool for assessing clinical pain.
Change in The Sheehan Disability Scale (SDS)
Time frame: 0, 30, and 90 days - Primary endpoint is 30 days
A measurement tool for assessing functional impairment in three inter-related domains: work/school, social and family life.
Change in The Endicott Work Productivity Scale (EWPS)
Time frame: 0, 30, and 90 days - Primary endpoint is 30 days
A brief self-report questionnaire designed to obtain a sensitive measure of work productivity.
Change in Cognitive and Physical Functioning Questionnaire (CPFQ)
Time frame: 0, 30, and 90 days - Primary endpoint is 30 days
A brief scale that measures cognitive and executive dysfunction.
Change in The WILD 5 Wellness Scale (W5WS)
Time frame: 0, 30, and 90 days - Primary endpoint is 30 days
A brief scale designed specifically for this project to measure wellness.
Change in The WILD 5 Wellness Effort Scale (W5ES)
Time frame: 0, 30, and 90 days - Primary endpoint is 30 days
A scale designed specifically for this project to measure weekly adherence with program elements.
Change in The WILD 5 Wellness Elements Scale
Time frame: 0, 30, and 90 days - Primary endpoint is 30 days
A scale designed specifically for this project to measure elements of depression, anxiety, wellbeing, mindfulness, sleep quality, social connectedness, emotional eating, diet practices, pain, disability, work productivity, happiness, enthusiasm, resilience, and optimism.
The Post-Program Participant Questionnaire
Time frame: 90 days
A brief post study survey that captures participants' opinions about WILD 5 Wellness: 90-Day Intervention, and subjective ranking of their overall wellness.
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 5 Apr 2019.
- Results publication: PubMed 24026850Cooney GM, Dwan K, Greig CA, Lawlor DA, Rimer J, Waugh FR, McMurdo M, Mead GE. Exercise for depression. Cochrane Database Syst Rev. 2013 Sep 12;2013(9):CD004366. doi: 10.1002/14651858.CD004366.pub6.
- Results publication: PubMed 24331897Cruwys T, Dingle GA, Haslam C, Haslam SA, Jetten J, Morton TA. Social group memberships protect against future depression, alleviate depression symptoms and prevent depression relapse. Soc Sci Med. 2013 Dec;98:179-86. doi: 10.1016/j.socscimed.2013.09.013. Epub 2013 Sep 25.
- Results publication: PubMed 25406801Fardet A, Boirie Y. Associations between food and beverage groups and major diet-related chronic diseases: an exhaustive review of pooled/meta-analyses and systematic reviews. Nutr Rev. 2014 Dec;72(12):741-62. doi: 10.1111/nure.12153. Epub 2014 Nov 18.
- Results publication: PubMed 26046013Hui SK, Grandner MA. Associations between Poor Sleep Quality and Stages of Change of Multiple Health Behaviors among Participants of Employee Wellness Program. Prev Med Rep. 2015 Jan 1;2:292-299. doi: 10.1016/j.pmedr.2015.04.002.
- Results publication: PubMed 26132670Jeste DV, Palmer BW, Rettew DC, Boardman S. Positive psychiatry: its time has come. J Clin Psychiatry. 2015 Jun;76(6):675-83. doi: 10.4088/JCP.14nr09599.
- Results publication: PubMed 24294837Williams JM, Crane C, Barnhofer T, Brennan K, Duggan DS, Fennell MJ, Hackmann A, Krusche A, Muse K, Von Rohr IR, Shah D, Crane RS, Eames C, Jones M, Radford S, Silverton S, Sun Y, Weatherley-Jones E, Whitaker CJ, Russell D, Russell IT. Mindfulness-based cognitive therapy for preventing relapse in recurrent depression: a randomized dismantling trial. J Consult Clin Psychol. 2014 Apr;82(2):275-86. doi: 10.1037/a0035036. Epub 2013 Dec 2.
- Qualtrics security statementLink provided by the sponsor.
- Decision matrix: Cloud servicesLink provided by the sponsor.
- Online automated email serviceLink provided by the sponsor.
- Program Overview VideoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
Not yet recruitingPhase 2
Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Recruiting
Rewiring the Chronic Pain Experience: Single-Session Model of Pain Reprocessing Therapy (PRT) at The Ottawa Hospital
Chronic Pain
Active, not recruiting
Effects of Subtalar Mobilization With and Without Foot Core Strengthening in Chronic Plantar Heel Pain
Chronic Plantar Heel Pain
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, Psychological, 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 6 inclusion and 5 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 5 Apr 2019. 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, 30, and 90 days - Primary endpoint is 30 days). The study lists 16 primary outcomes in all. 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 NCT02918513, which also lists 6 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 5 Apr 2019.