<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03813901</url>
  </required_header>
  <id_info>
    <org_study_id>NMP/Arsha 2091</org_study_id>
    <nct_id>NCT03813901</nct_id>
  </id_info>
  <brief_title>Impact of 'Samalochana' Program on Women Who Have Experienced Intimate Partner Violence (IPV)</brief_title>
  <official_title>Advaita Vedanta and Counselling for Women Who Have Experienced Intimate Partner Violence: Impact on Women's Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NMP Medical Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Warwick Research Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Arsha Vidya Study Centre, Tamilnadu, India</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NMP Medical Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Violence has immediate effects on women's health, which in some cases, is fatal. Physical,&#xD;
      mental and behavioural health consequences can also persist long after the violence has&#xD;
      stopped. Violence against women and girls occurs in every country and culture and is rooted&#xD;
      in social and cultural attitudes and norms that privilege men over women and boys over girls.&#xD;
&#xD;
      Research consistently finds that the more severe the abuse, the greater its impact on women's&#xD;
      physical and mental health. In addition, the negative health consequences can persist long&#xD;
      after abuse has stopped.Present work shares the impact of arsha vidya counselling for women&#xD;
      who has been victim of violence.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 21, 2018</start_date>
  <completion_date type="Actual">December 21, 2018</completion_date>
  <primary_completion_date type="Actual">November 22, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Quality of Life</measure>
    <time_frame>Change from baseline to 12-week</time_frame>
    <description>Quality of Life was measured using SF-36 questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Anxiety</measure>
    <time_frame>Change from Baseline to 12-weeks</time_frame>
    <description>Anxiety was measured using Beck Anxiety Inventory</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Domestic Violence</condition>
  <condition>Intimate Partner Violence</condition>
  <arm_group>
    <arm_group_label>Samalochana Counselling group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arsha Vidya advaita vedanta based counselling were given to the women</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Wait list group were not given any supportive care during the period. After that, they were offered the similar program as Counselling group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Samalochana Counselling</intervention_name>
    <description>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.</description>
    <arm_group_label>Samalochana Counselling group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Wait list control</intervention_name>
    <description>Wait list had no intervention offered during the study period. Afterwards, they were offered the counselling for the same duration.</description>
    <arm_group_label>Wait-list control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Woman&#xD;
&#xD;
          -  Able to attend regular counselling&#xD;
&#xD;
          -  Planning to remain in area for next 6 months&#xD;
&#xD;
          -  have experience intimate partner violence (physical, emotional, psychological, and/or&#xD;
             sexual), including coercive control from a current or former partner in the previous&#xD;
             12 months and no later than 3 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Man&#xD;
&#xD;
          -  Under 19 years of age&#xD;
&#xD;
          -  Cannot attend at regular basis&#xD;
&#xD;
          -  Living outside of the selected study sites, or planning to relocate in next 4 months&#xD;
&#xD;
          -  Separated more than 3 years ago&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neha Sharma, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Warwick Research Services</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Buddhatmananda Saraswati</last_name>
    <role>Study Chair</role>
    <affiliation>Arsha Vidya Study Centre, India</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vandana Mishra</last_name>
    <role>Study Director</role>
    <affiliation>Sarvatra International, South Africa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Divya</name>
      <address>
        <city>Jaipur</city>
        <state>Rajasthan</state>
        <zip>302019</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>March 2, 2019</last_update_submitted>
  <last_update_submitted_qc>March 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03813901
org study id: NMP/Arsha 2091
nct id: NCT03813901
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in Quality of Life
time frame: Change from baseline to 12-week
description: Quality of Life was measured using SF-36 questionnaire
measure: Change in Anxiety
time frame: Change from Baseline to 12-weeks
description: Anxiety was measured using Beck Anxiety Inventory
arm group label: Samalochana Counselling group
arm group type: Experimental
description: Arsha Vidya advaita vedanta based counselling were given to the women
arm group label: Wait-list control group
arm group type: Other
description: Wait list group were not given any supportive care during the period. After that, they were offered the similar program as Counselling group.
intervention type: Other
intervention name: Samalochana Counselling
description: 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.
arm group label: Samalochana Counselling group
intervention type: Other
intervention name: Wait list control
description: Wait list had no intervention offered during the study period. Afterwards, they were offered the counselling for the same duration.
arm group label: Wait-list control group
criteria: 
gender: Female
gender based: Yes
gender description: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Neha Sharma, PhD
role: Principal Investigator
affiliation: Warwick Research Services
last name: Buddhatmananda Saraswati
role: Study Chair
affiliation: Arsha Vidya Study Centre, India
last name: Vandana Mishra
role: Study Director
affiliation: Sarvatra International, South Africa
facility: 
country: India
responsible party type: Sponsor
sharing ipd: Undecided