MindfulnessNCT05262075
Online Mindful & Resiliency Program Intimate Partner Violence
A study testing Online Mindfulness Resiliency Program in people with Mindfulness and Intimate Partner Violence, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this study is to explore the experiences and benefits of offering an online mindfulness program that integrates resiliency factors to women. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mindfulness, Intimate Partner Violence
- What is being tested?
- Online Mindfulness Resiliency Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2022to 5 Sep 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 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women who self-identify as having or who are currently experiencing intimate partner violence
- English or Spanish speaking
- Between 18 and 85 years old.
Who cannot join
- Males
- No experience of partner violence
- Not fluent in either English or Spanish <18 and >85 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Experiences of an Online Mindfulness Program Integrating Resiliency Factors for Women Who Have Experienced Intimate Partner Violence
The purpose of this study is to explore the experiences and benefits of offering an online mindfulness program that integrates resiliency factors to women.
Read the detailed description
The purpose of this study is to explore the experiences and benefits of offering an online mindfulness program that integrates resiliency factors to women. Investigators will recruit participants via email and social media flyers to local community sites as well as approved Loma Linda University affiliated sites. Participants who consent will then complete a Demographic Questionnaire(before initial session of program), Pre and Post Stress Surveys (at the start and end of each session), Five-Facet Mindfulness Questionnaire(before and after completion of the program), and a semi-structured interview after the completion of the program. The program will be done be 20-minutes sessions for 3x/week for 4 weeks.
- Conditions
- Mindfulness, Intimate Partner Violence
- Being tested
- Online Mindfulness Resiliency Program
- Keywords
- Mindfulness, Resiliency, Online, Domestic violence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Mindfulness Resiliency ProgramOther
An approximate 20 minute online mindfulness resiliency program offered 3/wk x 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness and Resiliency Program | Experimental | This is an online mindfulness program that integrates resiliency factors to women Receives: Other: Online Mindfulness Resiliency Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Stress
Participants rate their stress level at the beginning and end of each session on a scale of 1-10.
Measured: Change between Baseline and Week 5 of mindfulness training
Level of Self-Awareness
Self-reported 15-item questionnaire designed to provide information on self-awareness and suggests how effective mindfulness practices are. Responses will be recorded on a Likert scale from 0 to 5.
Measured: Change between Baseline and Week 5 of mindfulness training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start26 Jan 2022
- Primary completion5 Sep 2022
- Study completion5 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dragana Krpalek, Loma Linda University
- Investigators
- Dragrana Krpalek, PhD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262075
- Sponsor's protocol ID
- 5210387
- Status last verified
- Sep 2022
- First submitted
- 21 Feb 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experiences of an Online Mindfulness Program Integrating Resiliency Factors for Women Who Have Experienced Intimate Partner Violence
- ClinicalTrials.gov ID
- NCT05262075
- Acronym / sponsor ID
- 5210387
- Conditions
- Mindfulness, Intimate Partner Violence
- Keywords
- Mindfulness, Resiliency, Online, Domestic violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- 5 Sep 2022 (actual)
- First posted
- 2 Mar 2022 (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.
The purpose of this study is to explore the experiences and benefits of offering an online mindfulness program that integrates resiliency factors to women.
Detailed description
The purpose of this study is to explore the experiences and benefits of offering an online mindfulness program that integrates resiliency factors to women. Investigators will recruit participants via email and social media flyers to local community sites as well as approved Loma Linda University affiliated sites. Participants who consent will then complete a Demographic Questionnaire(before initial session of program), Pre and Post Stress Surveys (at the start and end of each session), Five-Facet Mindfulness Questionnaire(before and after completion of the program), and a semi-structured interview after the completion of the program. The program will be done be 20-minutes sessions for 3x/week for 4 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness and Resiliency Program | Experimental | Other: Online Mindfulness Resiliency ProgramThis is an online mindfulness program that integrates resiliency factors to women |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women who self-identify as having or who are currently experiencing intimate partner violence
- English or Spanish speaking
- Between 18 and 85 years old.
Key exclusion criteria (3 listed)
- Males
- No experience of partner violence
- Not fluent in either English or Spanish <18 and >85 years of age
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 |
|---|---|---|
| Online Mindfulness Resiliency ProgramAn approximate 20 minute online mindfulness resiliency program offered 3/wk x 4 weeks. | Other | Mindfulness and Resiliency Program |
Primary outcome
Level of Stress
Time frame: Change between Baseline and Week 5 of mindfulness training
Participants rate their stress level at the beginning and end of each session on a scale of 1-10.
Level of Self-Awareness
Time frame: Change between Baseline and Week 5 of mindfulness training
Self-reported 15-item questionnaire designed to provide information on self-awareness and suggests how effective mindfulness practices are. Responses will be recorded on a Likert scale from 0 to 5.
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 23 Sep 2022.
- 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.
Dragrana Krpalek, PhD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Mindfulness Resiliency Program in people with Mindfulness and Intimate Partner Violence, run by Loma Linda University 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 3 inclusion and 3 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 23 Sep 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?
Level of Stress (time frame: Change between Baseline and Week 5 of mindfulness training). The study lists 2 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 23 Sep 2022.