Impact of an Integrated Intervention on Mental Health in Survivors of Intimate Partner Violence

September 27, 2015 updated by: Macmillan Research Group UK

Randomised Controlled Trial of an Integrated Intervention on Mental Health in Survivors of Intimate Partner Violence

Intimate partner violence (IPV) against women have negative mental health consequences for survivors; interventions designed to improve survivors' depressive symptoms and health status are limited.Present study evaluate the effectiveness of an integrated intervention in reducing intimate partner violence (IPV) improving health status.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Gujarat
      • Mahesana, Gujarat, India, 384001
        • Sonal Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women over 18
  • For those who agreed to participate
  • Given written consent
  • Screening for abuse was positive

Exclusion Criteria:

  • Screened Negative
  • serious mental condition including suicide, hallucination, Dementia
  • Drug or substance abuse, alcoholism
  • Pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
The integrated intervention consisted of 12 week of program and group support, based on the freedom program by pet craven. The former component was provided covering beliefs held and tactics used by the domestic violence abusers and took about 45 minutes. It included protection and enhanced choice-making and problem-solving skills.
Behavioral: Intervention Group
No Intervention: Wait list control group
The group was listed in wait list and were offered the same intervention and support on completion of study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Depression
Time Frame: Change from Baseline in Beck Depression Inventory at 12 weeks
Change from Baseline in Beck Depression Inventory at 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Health Related Quality of Life
Time Frame: Change from baseline in SF-36 at 12 weeks
Change from baseline in SF-36 at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Macmillan Research Group UK

Collaborators

NMP Medical Research Institute

Investigators

  • Study Director: Bharat Chaudhari, MA, Sonal Foundation, India
  • Study Chair: Neha sharma, PhD, Macmillan research group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

October 7, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (Estimate)

October 9, 2013

Study Record Updates

Last Update Posted (Estimate)

September 29, 2015

Last Update Submitted That Met QC Criteria

September 27, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • Mac/NMP 0917

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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