Evaluation of the Impact of the Empowerment Program on Sheltered Battered Women (Violence)

April 4, 2022 updated by: Elif Güzide Emirza

The Effect of Mindfulness Based Empowerment Program on Self-Compassion, Self-Esteem and Ways of Coping With Stress of Women Experienced Violence: A Randomized-Controlled Study

This study aims to increase the level of self-compassion, improve their self-esteem and cope with stress so that women who are exposed to violence can fight violence more effectively, protect their physical and mental health, find the strength they need to direct their lives, and do all these through self-awareness, compassion and kindness. It is aimed to gain coping skills. For this purpose, a mindfulness-based strengthening program will be implemented.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

When the statistics on violence against women in the world are analyzed, it is seen that 16-25% of women are physically abused by their husbands, boyfriends or fiancees, and one out of every five women is exposed to this type of violence in their own home. It has been concluded that the approaches applied in intervention studies for women exposed to violence affect women's mental health positively, increase their self-esteem, improve their coping, problem-solving and decision-making skills, reduce their anger and stress levels, and increase their self-efficacy. In addition, it has been determined that mindfulness-based interventions applied to women who have been subjected to violence strengthen awareness and self-compassion, improve sense of belonging, compassion and problem-solving skills, reduce self-blame, depression, anxiety and suicidal thoughts, increase psychological well-being, and reduce PTSD symptoms. With the continuation of exposure to violence, women are insufficient to change their feelings and lives in a positive way, they are affected by the negative and judgmental attitudes of their environment, they struggle with all the negative effects of violence throughout their lives, they experience physical and mental disorders due to violence, and therefore they resort to harmful coping methods. In this sense, the aim of the study is to determine the effect of mindfulness-based empowerment program on self-compassion, self-esteem and ways of coping with stress in women exposed to violence.

The hypotheses of this study:

In the mindfulness-based empowerment program applied to women who have been subjected to violence, H0-1: There is no difference between the intervention group and the control group in terms of self-compassion.

H0-2: There is no difference between the intervention group and the control group in terms of self-esteem.

H0-3: There is no difference between the intervention group and the control group in terms of coping styles with stress.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Elif Güzide Emirza, Res. Asist.
  • Phone Number: +905433320212
  • Email: guzzide@hotmail.com

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women who have been exposed to at least one of the types of violence,
  • Women who can read, write and understand Turkish will be included in the study.

Exclusion Criteria:

  • Women with severe mental retardation,
  • Women with psychotic symptoms and impaired ability to assess reality,
  • Women who do not have insight due to psychiatric disorder,
  • Women whose cognitive functionality is impaired,
  • Women with any physical limitations will not be included in the study.

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: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Mindfulness-based empowerment programme
Behavioral: Mindfulness Based Empowerment Programme
Mindfulness Based Strengthening Program consists of 8 sessions, once a week. Each session has specific goals and objectives, and each session also has a separate theme along with its subject. The subject of the program sessions is as follows: 1st session; Getting to know, explaining the operation plan of the program, defining violence against women and its causes, 2nd session; Emotions and Perceptions, session 3; Being in the Body and Developing Self-Esteem; Session 4, Stress and Meeting Stress with Conscious Awareness; Session 5, The Case of Violence and the Meanings We Ascribe; Session 6, Aware Communication and Conflict Resolution; Session 7, Self-Care and Self-Compassion; Session 8 is Ending the Empowerment Program, Farewell, and a New Beginning. Each session is planned to last an average of 90-120 minutes. Mindfulness teachings and practices will be applied in the content of the program.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-Esteem
Time Frame: 8 weeks after enrollment
Coopersmith Self-Esteem Scale: Coopersmith (1967) found the reliability coefficient of the scale to be 0.91 for women and 0.80 for men. In addition, the Cronbach's alpha coefficient of the scale was determined as 0.86. Each item of the scale, which consists of 25 items, is determined according to two options as "suitable for me" and "not suitable for me". Scoring of the scale is made as "4" for each correct statement, "0" for each incorrect statement, the highest score that can be obtained from the scale is 100, and the lowest score is 0. As the score obtained from the scale increases, the self-esteem of individuals also increases. In the scale, a self-esteem level below 50 points is considered low, and a self-esteem level above 50 points is considered high. There is no reverse coded item in the scale.
8 weeks after enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ways of Coping with Stress
Time Frame: 8 weeks after enrollment
Styles of Coping with Stress Scale: The scale consists of 30 items in total. The scale is a 4-point Likert type measurement tool. Options are rated as "Not at all suitable", "Not very suitable", "Appropriate" and "Totally appropriate". In the evaluation of the scale, the total score cannot be obtained, and the scores are calculated separately for each subscale. The answers given to each item are scored as 0,1,2,3, and the scores of each individual in each subgroup are summed up one by one and divided by the number of items in that group. Thus, the average score of each subgroup is obtained. However, items 1 and 9 in the Seeking Social Support group are reverse scored. The increase in the scores obtained from each subscale indicates that the approach of that scale is used more strongly.
8 weeks after enrollment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-Compassion
Time Frame: 8 weeks after enrollment
Self-Compassion Scale: The scale is a measurement tool that evaluates the characteristics associated with the sub-dimensions of self-compassion and is based on the individual giving information about himself (self-report). The Self-Compassion Scale has a 5-point Likert-type rating: (1) never (2) rarely (3) often (4) often and (5) always. The scale consists of 26 items. In the confirmatory factor analysis, the existence of 6 sub-dimensions constituting the self-compassion structure was confirmed.
8 weeks after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Elif Güzide Emirza

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gazi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elif Güzide Emirza, Res. Asist., Gazi 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 (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 18, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 18, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EGUAY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

It is planned to share the study protocol, data analysis, informed consent form and clinical study report of the study.

IPD Sharing Time Frame

March 2022-December 2022

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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.

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