CClinicalTrials.gg
CompletedNCT04107025Updated Oct 25, 2019

Effects of a Legal Support Program on Women Experiencing Domestic Violence

An interventional study of HELP in Domestic Violence, Anxiety and Depression, sponsored by NMP Medical Research Institute. Completed at 2 sites in India. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2019-10-25.

Sponsored by NMP Medical Research Institute · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Apr 2017, registered Sep 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Female
01

Study summary

Intimate partner violence (IPV) is a major public health concern. Worldwide, 1 in 3 women have experienced domestic abuse/ violence in their lifetime. In most cases, family lawyers, advocates are first contact before the police. If the children are involved, finding the legal options become the priority for women before leaving the abuser.

The purpose of this study was to compare the effectiveness of the HELP (Health, Education Legal Support Program) intervention among IPV survivors.

02

Conditions studied

  • Domestic Violence
  • Anxiety
  • Depression
  • Stress

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03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 56 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

NMP Medical Research Institute is the lead sponsor of 30 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Female survivors of Intimate Partner Violence
  • 18 years old or older
  • Gives informed consent

Exclusion criteria

Exclusion Criteria:

  • Diagnosed mental health condition
  • Terminally ill
  • Chronic condition
  • On psychiatric medication
  • Sexual assault
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    Intervention

    As part of the intervention, along with legal opinions, advise and support, participants were provided counselling support during their time to help survivors with trauma of legal proceedings.

    Other: HELP

  • No intervention
    Usual Care

    Participants were scheduled for legal consultancy only.

Interventions

  • OtherHELP

    Individual counseling were given to each intervention group participant. They were assisted with safety, emotional and mental support and referrals for health and financial assistance. Participants were also given handout to manage anxiety and panic situations during the legal procedures.

06

What researchers measure

Primary outcomes

  1. Anxiety

    Anxiety symptoms were assessed using the Hospital Anxiety Depression Scale

    Time frame: Change from baseline anxiety symptoms at 4 weeks

  2. Depression

    Depression symptoms were assessed using the Hospital Anxiety Depression Scale

    Time frame: Change from baseline depression symptoms at 4 weeks

  3. Stress

    Perceived Stress Scale was used to assess stress symptoms

    Time frame: Change from baseline stress symptoms at 4 weeks

Secondary outcomes

  1. Self esteem

    Rosenberg's Self-Esteem Scale was used to measure self esteem

    Time frame: Change from baseline self esteem at 4 weeks

07

Study locations

2 sites
  • Gyansanjeevani
    Bundi, Rajasthan, India
  • Gyansanjeevani
    Jaipur, Rajasthan, India
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04107025
Lead sponsor
NMP Medical Research Institute
Collaborators
Warwick Research Services
Responsible party
Sponsor
First posted
Sep 27, 2019
Start date
Apr 28, 2017
Primary completion
Jan 30, 2018
Completion
Mar 12, 2018
Last update
Oct 25, 2019

Study contacts

Neha Sharma, PhD
study director · Warwick Research Services
Anurag Sharma, MPhil
study chair · Patan Girls College
Rekha Khandelwal, PhD
principal investigator · NMP Medical Research Institute, India

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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