NCT03813901

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 21, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
Last Updated

March 5, 2019

Status Verified

January 1, 2019

Enrollment Period

5 months

First QC Date

January 21, 2019

Last Update Submit

March 2, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Quality of Life

    Quality of Life was measured using SF-36 questionnaire

    Change from baseline to 12-week

Secondary Outcomes (1)

  • Change in Anxiety

    Change from Baseline to 12-weeks

Study Arms (2)

Samalochana Counselling group

EXPERIMENTAL

Arsha Vidya advaita vedanta based counselling were given to the women

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.

Other: Wait list control

Interventions

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.

Samalochana Counselling group

Wait list had no intervention offered during the study period. Afterwards, they were offered the counselling for the same duration.

Wait-list control group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Divya

Jaipur, Rajasthan, 302019, India

Location

Study Officials

  • Neha Sharma, PhD

    Warwick Research Services

    PRINCIPAL INVESTIGATOR
  • Buddhatmananda Saraswati

    Arsha Vidya Study Centre, India

    STUDY CHAIR
  • Vandana Mishra

    Sarvatra International, South Africa

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2019

First Posted

January 23, 2019

Study Start

June 21, 2018

Primary Completion

November 22, 2018

Study Completion

December 21, 2018

Last Updated

March 5, 2019

Record last verified: 2019-01

Locations