NCT01958554

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

September 29, 2015

Status Verified

September 1, 2015

Enrollment Period

5 months

First QC Date

October 7, 2013

Last Update Submit

September 27, 2015

Conditions

Domestic Violence

Outcome Measures

Primary Outcomes (1)

  • Depression

    Change from Baseline in Beck Depression Inventory at 12 weeks

Secondary Outcomes (1)

  • Health Related Quality of Life

    Change from baseline in SF-36 at 12 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Wait list control group

NO INTERVENTION

The group was listed in wait list and were offered the same intervention and support on completion of study period.

Interventions

Intervention GroupBEHAVIORAL
Intervention Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sonal Foundation

Mahesāna, Gujarat, 384001, India

Location

Study Officials

  • Bharat Chaudhari, MA

    Sonal Foundation, India

    STUDY DIRECTOR

  • Neha sharma, PhD

    Macmillan Research Group

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2013

First Posted

October 9, 2013

Study Start

October 1, 2013

Primary Completion

March 1, 2014

Study Completion

June 1, 2014

Last Updated

September 29, 2015

Record last verified: 2015-09

Locations

IN(1)