Domestic ViolencePhase 2NCT01958554
Impact of an Integrated Intervention on Mental Health in Survivors of Intimate Partner Violence
A Phase 2 study testing Intervention Group in people with Domestic Violence, run by Macmillan Research Group UK at 1 site in India.
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)… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Domestic Violence
- What is being tested?
- Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2013to Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women over 18
- For those who agreed to participate
- Given written consent
- Screening for abuse was positive
Who cannot join
- Screened Negative
- serious mental condition including suicide, hallucination, Dementia
- Drug or substance abuse, alcoholism
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Domestic Violence
- Being tested
- Intervention Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Measured: Change from Baseline in Beck Depression Inventory at 12 weeks
Secondary outcomes (1)
Health Related Quality of Life
Measured: Change from baseline in SF-36 at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Domestic ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Macmillan Research Group UK
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NMP Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Bharat Chaudhari, MA, Study director, Sonal Foundation, IndiaNeha sharma, PhD, Study chair, Macmillan Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958554
- Sponsor's protocol ID
- Mac/NMP 0917
- Status last verified
- Sep 2015
- First submitted
- 7 Oct 2013
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of an Integrated Intervention on Mental Health in Survivors of Intimate Partner Violence
- ClinicalTrials.gov ID
- NCT01958554
- Acronym / sponsor ID
- Mac/NMP 0917
- Conditions
- Domestic Violence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Macmillan Research Group UKIndustry (pharma, biotech, devices)
- Collaborators
- NMP Medical Research Institute
- Study start
- Oct 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 9 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Intervention GroupThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women over 18
- For those who agreed to participate
- Given written consent
- Screening for abuse was positive
Key exclusion criteria (4 listed)
- Screened Negative
- serious mental condition including suicide, hallucination, Dementia
- Drug or substance abuse, alcoholism
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention Group | Behavioural | Intervention Group |
Primary outcome
Depression
Time frame: Change from Baseline in Beck Depression Inventory at 12 weeks
1 secondary outcome
Health Related Quality of Life
Time frame: Change from baseline in SF-36 at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2015.
Related trials for Domestic Violence
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Metacognitive Interpersonal Therapy for Male Intimate Partner Violence Perpetrators With Personality Disorders
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Evaluation of the Impact on Mental and Physical Health of Caring for Women Who Are Victims of Sexual and Gender-based Violence, Using a Coordinated Multidisciplinary Approach in Women's Centres or Traditional Health Centres.
Domestic and/or Sexual Violence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bharat Chaudhari, MA study director
Sonal Foundation, India
Neha sharma, PhD study chair
Macmillan Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intervention Group in people with Domestic Violence, run by Macmillan Research Group UK at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: Change from Baseline in Beck Depression Inventory at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2015.