Battered WomenViolenceNCT05310656
Evaluation of the Impact of the Empowerment Program on Sheltered Battered Women
A study testing Mindfulness Based Empowerment Programme in people with Battered Women and Violence, Domestic, run by Elif Güzide Emirza.
Trial summary
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Battered Women, Violence, Domestic, Mindfulness
- What is being tested?
- Mindfulness Based Empowerment Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 18 Aug 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Battered Women, Violence, Domestic, Mindfulness
- Being tested
- Mindfulness Based Empowerment Programme
- Keywords
- women, violence, mindfulness, empowerment programme, self-compassion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Empowerment ProgrammeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based empowerment programme | Experimental | Not described Receives: Behavioral: Mindfulness Based Empowerment Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Esteem
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.
Measured: 8 weeks after enrollment
Secondary outcomes (1)
Ways of Coping with Stress
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.
Measured: 8 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion18 Jul 2022 (estimated)
- Study completion18 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Battered WomenStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The universe of the research will be the women who have been subjected to violence staying in women's shelters in a province in Turkey. Women who volunteer to participate in the study will be included in the study. As a result of the power analysis using the G\*Power 3.1 program; With 95% power, 5% margin of error and d=0.84 effect size, a total of at least 42 samples was found to be sufficient (n₁=21; n₂=21). However, considering that losses may also occur, it was planned to work with a total of 60 women, 30 of whom were interventions and 30 were controls. Women who meet the inclusion criteria will be randomly assigned to the intervention and control groups, and at the same time, stratified block randomization will be performed (n₁= 30; n₂=30). The number of people in the group was determined as 10 for reasons such as keeping individuals active, increasing interactive working time, and providing more sharing opportunities.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elif Güzide Emirza
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Sponsor-investigator, Elif Güzide Emirza, Gazi University
- Investigators
- Elif Güzide Emirza, Res. Asist., Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310656
- Sponsor's protocol ID
- EGUAY
- Acronym
- Violence
- Status last verified
- Apr 2022
- First submitted
- 4 Mar 2022
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is planned to share the study protocol, data analysis, informed consent form and clinical study report of the study.
Publications
Emirza EG, Bilgili N. The Effect of Mindfulness-Based Empowerment Program on Self-Compassion, Self-Esteem and Ways of Coping With Stress of Women Experienced Violence: A Randomised Controlled Study. Int J Ment Health Nurs. 2024 Dec;33(6):2314-2325. doi: 10.1111/inm.13401. Epub 2024 Aug 12.
PubMed 39135298
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05310656
- Acronym / sponsor ID
- Violence / EGUAY
- Conditions
- Battered Women, Violence, Domestic, Mindfulness
- Keywords
- women, violence, mindfulness, empowerment programme, self-compassion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Elif Güzide EmirzaUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 18 Jul 2022 (estimated)
- Study completion
- 18 Aug 2022 (estimated)
- First posted
- 5 Apr 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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The universe of the research will be the women who have been subjected to violence staying in women's shelters in a province in Turkey. Women who volunteer to participate in the study will be included in the study. As a result of the power analysis using the G*Power 3.1 program; With 95% power, 5% margin of error and d=0.84 effect size, a total of at least 42 samples was found to be sufficient (n₁=21; n₂=21). However, considering that losses may also occur, it was planned to work with a total of 60 women, 30 of whom were interventions and 30 were controls. Women who meet the inclusion criteria will be randomly assigned to the intervention and control groups, and at the same time, stratified block randomization will be performed (n₁= 30; n₂=30). The number of people in the group was determined as 10 for reasons such as keeping individuals active, increasing interactive working time, and providing more sharing opportunities.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based empowerment programme | Experimental | Behavioral: Mindfulness Based Empowerment Programme |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Mindfulness Based Empowerment ProgrammeMindfulness 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. | Behavioural | Mindfulness-based empowerment programme |
Primary outcome
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.
1 secondary outcome
Ways of Coping with Stress
Time frame: 8 weeks after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Derived from this study: PubMed 39135298Emirza EG, Bilgili N. The Effect of Mindfulness-Based Empowerment Program on Self-Compassion, Self-Esteem and Ways of Coping With Stress of Women Experienced Violence: A Randomised Controlled Study. Int J Ment Health Nurs. 2024 Dec;33(6):2314-2325. doi: 10.1111/inm.13401. Epub 2024 Aug 12.
- Individual participant dataSharing planned: Yes. It is planned to share the study protocol, data analysis, informed consent form and clinical study report of the study.
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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.
Elif Güzide Emirza, Res. Asist. principal investigator
Gazi University
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Empowerment Programme in people with Battered Women and Violence, Domestic, run by Elif Güzide Emirza.
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 2 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: status not confirmed, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elif Güzide Emirza, Res. Asist. (+905433320212, guzzide@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Esteem (time frame: 8 weeks after enrollment). 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 NCT05310656, which also lists 1 linked publication.
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 2022.