NCT05262075

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2022

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2022

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

7 months

First QC Date

February 21, 2022

Last Update Submit

September 21, 2022

Conditions

MindfulnessIntimate Partner Violence

Keywords

MindfulnessResiliencyOnlineDomestic violence

Outcome Measures

Primary Outcomes (2)

  • Level of Stress

    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

    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

Study Arms (1)

Mindfulness and Resiliency Program

EXPERIMENTAL

This is an online mindfulness program that integrates resiliency factors to women

Other: Online Mindfulness Resiliency Program

Interventions

Online Mindfulness Resiliency ProgramOTHER

An approximate 20 minute online mindfulness resiliency program offered 3/wk x 4 weeks.

Mindfulness and Resiliency Program

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women who self-identify as having or who are currently experiencing intimate partner violence
  • English or Spanish speaking
  • Between 18 and 85 years old.

You may not qualify if:

  • Males
  • No experience of partner violence
  • Not fluent in either English or Spanish \<18 and \>85 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University

Loma Linda, California, 92354, United States

Location

Study Officials

  • Dragrana Krpalek, PhD

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 21, 2022

First Posted

March 2, 2022

Study Start

January 26, 2022

Primary Completion

September 5, 2022

Study Completion

September 5, 2022

Last Updated

September 23, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)