Domestic ViolenceNCT03813901
Impact of 'Samalochana' Program on Women Who Have Experienced Intimate Partner Violence (IPV)
A study testing Samalochana Counselling in people with Domestic Violence and Intimate Partner Violence, run by NMP Medical Research Institute at 1 site in India.
Trial summary
Violence has immediate effects on women's health, which in some cases, is fatal. Physical, mental and behavioural health consequences can also persist long after the violence has stopped. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Domestic Violence, Intimate Partner Violence
- What is being tested?
- Samalochana Counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteIndia
- Study dates
- 21 Jun 2018to 21 Dec 2018
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Woman
- Able to attend regular counselling
- Planning to remain in area for next 6 months
- have experience intimate partner violence (physical, emotional, psychological, and/or sexual), including coercive control from a current or former partner in the previous 12 months and no later than 3 years.
Who cannot join
- Man
- Under 19 years of age
- Cannot attend at regular basis
- Living outside of the selected study sites, or planning to relocate in next 4 months
- Separated more than 3 years ago
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Advaita Vedanta and Counselling for Women Who Have Experienced Intimate Partner Violence: Impact on Women's Health
Violence has immediate effects on women's health, which in some cases, is fatal. Physical, mental and behavioural health consequences can also persist long after the violence has stopped. Violence against women and girls occurs in every country and culture and is rooted in social and cultural attitudes and norms that privilege men over women and boys over girls.
Research consistently finds that the more severe the abuse, the greater its impact on women's physical and mental health. In addition, the negative health consequences can persist long after abuse has stopped.Present work shares the impact of arsha vidya counselling for women who has been victim of violence.
- Conditions
- Domestic Violence, Intimate Partner Violence
- Being tested
- Samalochana Counselling, Wait list control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samalochana CounsellingOther
Counselling program was individual, based on advaita vedanta and traditional philosophical grounds to answer individual fears, concerns,conflicts and difficulties in order to cope and recover.
Wait list controlOther
Wait list had no intervention offered during the study period. Afterwards, they were offered the counselling for the same duration.
| Study group | Role | What they receive |
|---|---|---|
| Samalochana Counselling group | Experimental | Arsha Vidya advaita vedanta based counselling were given to the women Receives: Other: Samalochana Counselling |
| Wait-list control group | Other | Wait list group were not given any supportive care during the period. After that, they were offered the similar program as Counselling group. Receives: Other: Wait list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life
Quality of Life was measured using SF-36 questionnaire
Measured: Change from baseline to 12-week
Secondary outcomes (1)
Change in Anxiety
Anxiety was measured using Beck Anxiety Inventory
Measured: Change from Baseline to 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start21 Jun 2018
- Primary completion22 Nov 2018
- Study completion21 Dec 2018
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMP Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Warwick Research Services, Arsha Vidya Study Centre, Tamilnadu, India
- Responsible party
- Sponsor
- Investigators
- Neha Sharma, PhD, Principal investigator, Warwick Research ServicesBuddhatmananda Saraswati, Study chair, Arsha Vidya Study Centre, IndiaVandana Mishra, Study director, Sarvatra International, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813901
- Sponsor's protocol ID
- NMP/Arsha 2091
- Status last verified
- Jan 2019
- First submitted
- 21 Jan 2019
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advaita Vedanta and Counselling for Women Who Have Experienced Intimate Partner Violence: Impact on Women's Health
- ClinicalTrials.gov ID
- NCT03813901
- Acronym / sponsor ID
- NMP/Arsha 2091
- Conditions
- Domestic Violence, Intimate Partner Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- NMP Medical Research InstituteUniversity, hospital or other
- Collaborators
- Warwick Research Services, Arsha Vidya Study Centre, Tamilnadu, India
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 22 Nov 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 23 Jan 2019 (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.
Violence has immediate effects on women's health, which in some cases, is fatal. Physical, mental and behavioural health consequences can also persist long after the violence has stopped. Violence against women and girls occurs in every country and culture and is rooted in social and cultural attitudes and norms that privilege men over women and boys over girls.
Research consistently finds that the more severe the abuse, the greater its impact on women's physical and mental health. In addition, the negative health consequences can persist long after abuse has stopped.Present work shares the impact of arsha vidya counselling for women who has been victim of violence.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Samalochana Counselling group | Experimental | Other: Samalochana CounsellingArsha Vidya advaita vedanta based counselling were given to the women |
| Wait-list control group | Other | Other: Wait list controlWait list group were not given any supportive care during the period. After that, they were offered the similar program as Counselling group. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Woman
- Able to attend regular counselling
- Planning to remain in area for next 6 months
- have experience intimate partner violence (physical, emotional, psychological, and/or sexual), including coercive control from a current or former partner in the previous 12 months and no later than 3 years.
Key exclusion criteria (5 listed)
- Man
- Under 19 years of age
- Cannot attend at regular basis
- Living outside of the selected study sites, or planning to relocate in next 4 months
- Separated more than 3 years ago
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 |
|---|---|---|
| Samalochana CounsellingCounselling program was individual, based on advaita vedanta and traditional philosophical grounds to answer individual fears, concerns,conflicts and difficulties in order to cope and recover. | Other | Samalochana Counselling group |
| Wait list controlWait list had no intervention offered during the study period. Afterwards, they were offered the counselling for the same duration. | Other | Wait-list control group |
Primary outcome
Change in Quality of Life
Time frame: Change from baseline to 12-week
Quality of Life was measured using SF-36 questionnaire
1 secondary outcome
Change in Anxiety
Time frame: Change from Baseline to 12-weeks
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 5 Mar 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Domestic Violence
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Self-Dehumanization and Hesitation to Report Domestic Violence
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Community Resiliency Collective Efficacy Intervention
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Enrolling by invitation
Evaluation of a Trauma-Informed Partner Violence Intervention Program
Domestic Violence, Post Traumatic Stress Disorder
Not yet recruiting
Metacognitive Interpersonal Therapy for Male Intimate Partner Violence Perpetrators With Personality Disorders
Intimate Partner Violence, Personality Disorders
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.
Neha Sharma, PhD principal investigator
Warwick Research Services
Buddhatmananda Saraswati study chair
Arsha Vidya Study Centre, India
Vandana Mishra study director
Sarvatra International, South Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Samalochana Counselling in people with Domestic Violence and Intimate Partner Violence, run by NMP Medical Research Institute at 1 site in India.
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 4 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: finished, as of the sponsor's last update on 5 Mar 2019. 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 India. 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?
Change in Quality of Life (time frame: Change from baseline to 12-week). 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 5 Mar 2019.