Domestic ViolenceNCT06061029
Brief Yoga and Mindfulness for Women Who Have Experienced Domestic Violence
A study testing Brief Yoga- and Mindfulness-Based Psychoeducation Program in people with Domestic Violence, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to examine the effectiveness of a brief yoga- and mindfulness-based psychoeducation program and its working mechanisms in improving psychological health parameters (depression, anxiety, and stress) among women who have experienced domestic violence (DV). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Domestic Violence
- What is being tested?
- Brief Yoga- and Mindfulness-Based Psychoeducation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2023to 20 Sep 2023
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The inclusion criteria for this study required participants to be women aged 18 years or older who had experienced domestic violence in the previous 12 months but were no longer in an ongoing domestic violence situation. Additionally, participants needed to have secure access to a smartphone or a laptop / Personal Computer.
Who cannot join
- Refusal to give consent or missing more than one session of the psychoeducation program were the exclusion criteria. The individuals who met the absence criterion were still able to continue the rest of the sessions; however, their questionnaires were not included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Brief Yoga- and Mindfulness-Based Psychoeducation Program for Women Who Have Experienced Domestic Violence: A Randomized Control Trial Study
This study aimed to examine the effectiveness of a brief yoga- and mindfulness-based psychoeducation program and its working mechanisms in improving psychological health parameters (depression, anxiety, and stress) among women who have experienced domestic violence (DV).
In a randomized controlled trial, 51 DV-victimized women were assigned to an intervention group (n = 27) or a waitlist control group (n = 24). The intervention was a five-week yoga- and mindfulness-based psychoeducation program.
The researchers planned to provide support for the effectiveness of a brief yoga- and mindfulness-based psychoeducation program for improving the psychological health of DV-victimized women. Self-compassion and rumination were hypothesized as working mechanisms underlying the intervention's success.
- Conditions
- Domestic Violence
- Being tested
- Brief Yoga- and Mindfulness-Based Psychoeducation Program
- Keywords
- Brief yoga and mindfulness, online psychoeducation, self-compassion, rumination, domestic violence, psychological health
- Medical subject headings
- Rumination Syndrome, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Yoga- and Mindfulness-Based Psychoeducation ProgramBehavioural
A unique mindfulness psychoeducation program incorporating features of Hatha yoga and mindfulness-based cognitive therapy, plus the main concepts of self-compassion
| Study group | Role | What they receive |
|---|---|---|
| Yoga- and Mindfulness-Based Psychoeducation Program Group | Experimental | Not described Receives: Behavioral: Brief Yoga- and Mindfulness-Based Psychoeducation Program |
| Waitlist Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Anxiety Stress Scales-21
To measure the occurrence of symptoms associated with depression, anxiety, and stress. In this scale, higher scores mean higher depression, anxiety, or stress.
Measured: 6 weeks
The Self-Compassion Scale-Short Form
To measure self-compassion level. In this scale higher scores mean better/higher self-compassion.
Measured: 6 weeks
The Brief State Rumination Inventory
To measure rumination level. In this scale higher scores mean higher rumination.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start10 Mar 2023
- Primary completion18 Aug 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Domestic ViolenceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Navidreza Hosseinzadeh ASL, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061029
- Sponsor's protocol ID
- 2023/06
- Status last verified
- Sep 2023
- First submitted
- 19 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data supporting the results of this study can be obtained from the corresponding author upon a reasonable request. The data cannot be made publicly accessible due to their containing sensitive information that could potentially breach the confidentiality of research participants. Nonetheless, the authors are dedicated to providing access to the data for interested researchers in a responsible and transparent manner, while adhering to all applicable ethical and legal standards.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Yoga- and Mindfulness-Based Psychoeducation Program for Women Who Have Experienced Domestic Violence: A Randomized Control Trial Study
- ClinicalTrials.gov ID
- NCT06061029
- Acronym / sponsor ID
- 2023/06
- Conditions
- Domestic Violence
- Keywords
- Brief yoga and mindfulness, online psychoeducation, self-compassion, rumination, domestic violence, psychological health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 18 Aug 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 29 Sep 2023 (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 aimed to examine the effectiveness of a brief yoga- and mindfulness-based psychoeducation program and its working mechanisms in improving psychological health parameters (depression, anxiety, and stress) among women who have experienced domestic violence (DV).
In a randomized controlled trial, 51 DV-victimized women were assigned to an intervention group (n = 27) or a waitlist control group (n = 24). The intervention was a five-week yoga- and mindfulness-based psychoeducation program.
The researchers planned to provide support for the effectiveness of a brief yoga- and mindfulness-based psychoeducation program for improving the psychological health of DV-victimized women. Self-compassion and rumination were hypothesized as working mechanisms underlying the intervention's success.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga- and Mindfulness-Based Psychoeducation Program Group | Experimental | Behavioral: Brief Yoga- and Mindfulness-Based Psychoeducation Program |
| Waitlist Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criteria for this study required participants to be women aged 18 years or older who had experienced domestic violence in the previous 12 months but were no longer in an ongoing domestic violence situation. Additionally, participants needed to have secure access to a smartphone or a laptop / Personal Computer.
Key exclusion criteria (1 listed)
- Refusal to give consent or missing more than one session of the psychoeducation program were the exclusion criteria. The individuals who met the absence criterion were still able to continue the rest of the sessions; however, their questionnaires were not included.
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 |
|---|---|---|
| Brief Yoga- and Mindfulness-Based Psychoeducation ProgramA unique mindfulness psychoeducation program incorporating features of Hatha yoga and mindfulness-based cognitive therapy, plus the main concepts of self-compassion | Behavioural | Yoga- and Mindfulness-Based Psychoeducation Program Group |
Primary outcome
Depression Anxiety Stress Scales-21
Time frame: 6 weeks
To measure the occurrence of symptoms associated with depression, anxiety, and stress. In this scale, higher scores mean higher depression, anxiety, or stress.
The Self-Compassion Scale-Short Form
Time frame: 6 weeks
To measure self-compassion level. In this scale higher scores mean better/higher self-compassion.
The Brief State Rumination Inventory
Time frame: 6 weeks
To measure rumination level. In this scale higher scores mean higher rumination.
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 29 Sep 2023.
- Individual participant dataSharing planned: Undecided. The data supporting the results of this study can be obtained from the corresponding author upon a reasonable request. The data cannot be made publicly accessible due to their containing sensitive information that could potentially breach the confidentiality of research participants. Nonetheless, the authors are dedicated to providing access to the data for interested researchers in a responsible and transparent manner, while adhering to all applicable ethical and legal standards.
Related trials for Domestic Violence
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Domestic Violence, Post Traumatic Stress Disorder
Not yet recruiting
Metacognitive Interpersonal Therapy for Male Intimate Partner Violence Perpetrators With Personality Disorders
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RecruitingObservational study
Evaluation of the Impact on Mental and Physical Health of Caring for Women Who Are Victims of Sexual and Gender-based Violence, Using a Coordinated Multidisciplinary Approach in Women's Centres or Traditional Health Centres.
Domestic and/or Sexual Violence
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Yoga- and Mindfulness-Based Psychoeducation Program in people with Domestic Violence, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 29 Sep 2023. 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 Turkey (Türkiye). 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?
Depression Anxiety Stress Scales-21 (time frame: 6 weeks). The study lists 3 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 29 Sep 2023.