- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05262075
Online Mindful & Resiliency Program Intimate Partner Violence
September 21, 2022 updated by: Dragana Krpalek, Loma Linda University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
4
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Loma Linda, California, United States, 92354
- Loma Linda University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women who self-identify as having or who are currently experiencing intimate partner violence
- English or Spanish speaking
- Between 18 and 85 years old.
Exclusion Criteria:
- Males
- No experience of partner violence
- Not fluent in either English or Spanish <18 and >85 years of age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Mindfulness and Resiliency Program
This is an online mindfulness program that integrates resiliency factors to women
|
An approximate 20 minute online mindfulness resiliency program offered 3/wk x 4 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change between Baseline and Week 5 of mindfulness training
|
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.
|
Change between Baseline and Week 5 of mindfulness training
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dragrana Krpalek, PhD, Loma Linda University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 26, 2022
Primary Completion (ACTUAL)
September 5, 2022
Study Completion (ACTUAL)
September 5, 2022
Study Registration Dates
First Submitted
February 21, 2022
First Submitted That Met QC Criteria
February 21, 2022
First Posted (ACTUAL)
March 2, 2022
Study Record Updates
Last Update Posted (ACTUAL)
September 23, 2022
Last Update Submitted That Met QC Criteria
September 21, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 5210387
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intimate Partner Violence
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedDomestic Violence | Intimate Partner ViolenceUnited States
-
NMP Medical Research InstituteWarwick Research Services; Arsha Vidya Study Centre, Tamilnadu, IndiaCompletedDomestic Violence | Intimate Partner ViolenceIndia
-
Yale UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingIntimate Partner ViolenceUnited States
-
Johns Hopkins UniversityUniversity of Missouri-Columbia; Centers for Disease Control and PreventionCompletedIntimate Partner ViolenceUnited States
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedIntimate Partner ViolenceUnited States
-
Northeastern UniversityRhode Island HospitalCompleted
-
Columbia UniversityNational Institute on Drug Abuse (NIDA)Completed
-
Joanne KlevensUniversity of Michigan; The Community Health and Social Services Center, Inc.Completed
-
University of UtahCompletedDomestic Violence | Intimate Partner ViolenceUnited States
-
Karolinska InstitutetRegion Stockholm; Jane and Dan Olsson Foundation for Scientific PurposesCompletedDomestic Violence | Family Violence | Intimate-partner ViolenceSweden
Clinical Trials on Online Mindfulness Resiliency Program
-
Yale UniversityCompletedMental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse) | Mental Health Wellness 1 | War-Related TraumaJordan
-
National Taipei University of Nursing and Health...Recruiting
-
Universiti Tunku Abdul RahmanUniversiti Putra MalaysiaUnknownAttention-deficit Hyperactivity DisorderMalaysia
-
Central South UniversityCompletedPTSD | HIV | Resilience | AIDS | Mindfulness-based Stress Reduction | ChinaChina
-
Massachusetts General HospitalUnknownStress | Burnout, ProfessionalUnited States
-
Massachusetts General HospitalCompletedStress | Paroxysmal Atrial FibrillationUnited States
-
University of PennsylvaniaNational Institute of Mental Health (NIMH)CompletedDepression | AnxietyUnited States
-
University of California, San FranciscoGenentech, Inc.CompletedCaregiver | Metastatic Gastrointestinal CarcinomaUnited States
-
Dana-Farber Cancer InstituteCompletedMonoclonal Gammopathy of Undetermined Significance | Smoldering Multiple MyelomaUnited States
-
Stony Brook UniversityNational Institute for Occupational Safety and Health (NIOSH/CDC)CompletedPTSD | Signs and Symptoms, RespiratoryUnited States