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NCT01958554 Clinical Trial

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

Domestic Violence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01958554
Other study ID # Mac/NMP 0917
Secondary ID
Status Completed
Phase Phase 2
First received October 7, 2013
Last updated September 27, 2015
Start date October 2013
Est. completion date June 2014

Study information
Verified date September 2015
Source Macmillan Research Group UK
Contact n/a
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date June 2014
Est. primary completion date March 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Intervention Group

Locations
Country Name City State
India Sonal Foundation Mahesana Gujarat

Sponsors (2)
Lead Sponsor Collaborator
Macmillan Research Group UK NMP Medical Research Institute

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Depression Change from Baseline in Beck Depression Inventory at 12 weeks No
Secondary Health Related Quality of Life Change from baseline in SF-36 at 12 weeks No
See also
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