Mental Abuse of AdultNCT04105933
Culturally Sensitive Cognitive Behavioural Therapy for the Survivors of Intimate Partner Violence (IPV)
A study testing CS-CBT and CBT in people with Mental Abuse of Adult and Emotional Abuse, run by NMP Medical Research Institute at 2 sites in India.
Trial summary
Women experience negative psychological outcomes long after the violent relationship has ended. Women suffer constant trauma and psychological distress being in emotional and mentally abusive relationship. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Mental Abuse of Adult, Emotional Abuse, Domestic Violence
- What is being tested?
- CS-CBT and CBT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesIndia
- Study dates
- 12 Mar 2017to 11 Feb 2018
- Phase
- Interventional
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women victim of intimate partner violence
- Still in relationship with abuser
- Willing to attend 16-weeks sessions
Who cannot join
- In need of clinical supervision or treatment
- Severe mental disorders
- Cognitive disorders
- Refused to give written consent
Trial locations and contacts
2 sites in 1 country.
India2 sites
Gyansaneejvani
Būndi, Rajasthan
NMP Medical Research Institute
Jaipur, Rajasthan
About this study
Official title: The Effects of Culturally Sensitive Cognitive Behavioural Therapy on Women Experienced Intimate Partner Violence
Women experience negative psychological outcomes long after the violent relationship has ended. Women suffer constant trauma and psychological distress being in emotional and mentally abusive relationship. Present study developed Culturally sensitive cognitive-behaviour therapy (CBT) to fit the client's cultural identity, context, and preferences.
- Conditions
- Mental Abuse of Adult, Emotional Abuse, Domestic Violence
- Being tested
- CS-CBT, CBT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS-CBTOther
Culturally sensitive Cognitive Behavioural Therapy was delivered individually, focused on potential cultural beliefs and attitudes that might collide with core values of CBT.
CBTOther
CBT was delivered at an individual level, dealing with thoughts, feelings and behaviours in the present. Thoughts are identified and then challenged, to make them more objective and rational.
| Study group | Role | What they receive |
|---|---|---|
| CS-CBT | Experimental | Culturally sensitive-CBT intervention was comprised of 16 sessions of cognitive behavioral therapy focused on culturally-specific beliefs and attitude. Receives: Other: CS-CBT |
| CBT | Active comparator | CBT intervention was comprised of 16 sessions of cognitive behavioral therapy. Receives: Other: CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological symptoms
Brief Symptom Inventory (BSI) was used to assess psychological complaints
Measured: Change from baseline to 16 weeks
Secondary outcomes (2)
Self esteem
Rosenberg Self-Esteem Scale was used to assess self esteem
Measured: Change from baseline to 16 weeks
Forgiveness
Heartland Forgiveness Scale was used to assess forgiveness to oneself, to other and to situation
Measured: Change from baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start12 Mar 2017
- Primary completion15 Dec 2017
- Study completion11 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Abuse of AdultStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMP Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Warwick Research Services
- Responsible party
- Sponsor
- Investigators
- Neha Sharma, PhD, Study director, Warwick Research ServicesRachana Khandelwal, PhD, Study chair, NMP Medical Research Institute, IndiaAnurag Sharma, MPhil, Principal investigator, Patan Girls College, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105933
- Sponsor's protocol ID
- NMP/013298
- Status last verified
- Sep 2019
- First submitted
- 25 Sep 2019
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Culturally Sensitive Cognitive Behavioural Therapy on Women Experienced Intimate Partner Violence
- ClinicalTrials.gov ID
- NCT04105933
- Acronym / sponsor ID
- NMP/013298
- Conditions
- Mental Abuse of Adult, Emotional Abuse, Domestic Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- NMP Medical Research InstituteUniversity, hospital or other
- Collaborators
- Warwick Research Services
- Study start
- 12 Mar 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 11 Feb 2018 (actual)
- First posted
- 26 Sep 2019 (actual)
- 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.
Women experience negative psychological outcomes long after the violent relationship has ended. Women suffer constant trauma and psychological distress being in emotional and mentally abusive relationship. Present study developed Culturally sensitive cognitive-behaviour therapy (CBT) to fit the client's cultural identity, context, and preferences.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CS-CBT | Experimental | Other: CS-CBTCulturally sensitive-CBT intervention was comprised of 16 sessions of cognitive behavioral therapy focused on culturally-specific beliefs and attitude. |
| CBT | Active comparator | Other: CBTCBT intervention was comprised of 16 sessions of cognitive behavioral therapy. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women victim of intimate partner violence
- Still in relationship with abuser
- Willing to attend 16-weeks sessions
Key exclusion criteria (4 listed)
- In need of clinical supervision or treatment
- Severe mental disorders
- Cognitive disorders
- Refused to give written consent
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 |
|---|---|---|
| CS-CBTCulturally sensitive Cognitive Behavioural Therapy was delivered individually, focused on potential cultural beliefs and attitudes that might collide with core values of CBT. | Other | CS-CBT |
| CBTCBT was delivered at an individual level, dealing with thoughts, feelings and behaviours in the present. Thoughts are identified and then challenged, to make them more objective and rational. | Other | CBT |
Primary outcome
Psychological symptoms
Time frame: Change from baseline to 16 weeks
Brief Symptom Inventory (BSI) was used to assess psychological complaints
2 secondary outcomes
Self esteem
Time frame: Change from baseline to 16 weeks
Forgiveness
Time frame: Change from baseline to 16 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 25 Oct 2019.
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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.
Neha Sharma, PhD study director
Warwick Research Services
Rachana Khandelwal, PhD study chair
NMP Medical Research Institute, India
Anurag Sharma, MPhil principal investigator
Patan Girls College, India
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CS-CBT and CBT in people with Mental Abuse of Adult and Emotional Abuse, run by NMP Medical Research Institute at 2 sites 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 3 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 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Psychological symptoms (time frame: Change from baseline to 16 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 25 Oct 2019.