- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04105933
Culturally Sensitive Cognitive Behavioural Therapy for the Survivors of Intimate Partner Violence (IPV)
October 24, 2019 updated by: NMP Medical Research Institute
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
92
Phase
- Not Applicable
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
-
-
Rajasthan
-
Bundi, Rajasthan, India
- Gyansaneejvani
-
Jaipur, Rajasthan, India
- NMP Medical Research Institute
-
-
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
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women victim of intimate partner violence
- Still in relationship with abuser
- Willing to attend 16-weeks sessions
Exclusion Criteria:
- In need of clinical supervision or treatment
- Severe mental disorders
- Cognitive disorders
- Refused to give written consent
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: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: CS-CBT
Culturally sensitive-CBT intervention was comprised of 16 sessions of cognitive behavioral therapy focused on culturally-specific beliefs and attitude.
|
Culturally sensitive Cognitive Behavioural Therapy was delivered individually, focused on potential cultural beliefs and attitudes that might collide with core values of CBT.
|
|
ACTIVE_COMPARATOR: CBT
CBT intervention was comprised of 16 sessions of cognitive behavioral therapy.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological symptoms
Time Frame: Change from baseline to 16 weeks
|
Brief Symptom Inventory (BSI) was used to assess psychological complaints
|
Change from baseline to 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self esteem
Time Frame: Change from baseline to 16 weeks
|
Rosenberg Self-Esteem Scale was used to assess self esteem
|
Change from baseline to 16 weeks
|
|
Forgiveness
Time Frame: Change from baseline to 16 weeks
|
Heartland Forgiveness Scale was used to assess forgiveness to oneself, to other and to situation
|
Change from baseline to 16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Rachana Khandelwal, PhD, NMP Medical Research Institute, India
- Principal Investigator: Anurag Sharma, MPhil, Patan Girls College, India
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 (ACTUAL)
March 12, 2017
Primary Completion (ACTUAL)
December 15, 2017
Study Completion (ACTUAL)
February 11, 2018
Study Registration Dates
First Submitted
September 25, 2019
First Submitted That Met QC Criteria
September 25, 2019
First Posted (ACTUAL)
September 26, 2019
Study Record Updates
Last Update Posted (ACTUAL)
October 25, 2019
Last Update Submitted That Met QC Criteria
October 24, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMP/013298
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Domestic Violence
-
Medical Research Council, South AfricaUniversity of GhanaUnknownSexual Violence | Domestic Violence | Physical ViolenceGhana
-
University of the Virgin IslandsUnknownDomestic Violence | Domestic AbuseVirgin Islands (U.S.)
-
Johns Hopkins UniversityUniversity of Pittsburgh; Office of Research on Women's Health (ORWH); Futures...CompletedViolence, Domestic | Violence, SexualUnited States
-
Funmilola OlaOlorunUniversity of IbadanCompletedDomestic Violence | Violence | AttitudeNigeria
-
Karolinska InstitutetRegion Stockholm; Jane and Dan Olsson Foundation for Scientific PurposesCompletedDomestic Violence | Family Violence | Intimate-partner ViolenceSweden
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedDomestic Violence | Intimate Partner ViolenceUnited States
-
NMP Medical Research InstituteWarwick Research Services; Arsha Vidya Study Centre, Tamilnadu, IndiaCompletedDomestic Violence | Intimate Partner ViolenceIndia
-
University of PittsburghCompletedViolence in Adolescence | Domestic ViolenceUnited States
-
University of SheffieldUniversity of HuddersfieldCompleted
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedViolence, Domestic | Violence-Related SymptomUnited States
Clinical Trials on CS-CBT
-
University of OxfordCompleted
-
Instituto Nacional de Psiquiatría Dr. Ramón de...Recruiting
-
London School of Hygiene and Tropical MedicineMedical Research Council; University of OxfordCompleted
-
Virginia Polytechnic Institute and State UniversityRecruiting
-
Eximis SurgicalTerminatedLaparoscopic Gynecological SurgeryUnited States
-
Shanghai Jiao Tong University School of MedicineCorrectSequence Therapeutics Co., LtdRecruitingHyperchylomicronemiaChina
-
CorrectSequence Therapeutics Co., LtdThe First Affiliated Hospital of Anhui Medical UniversityRecruiting
-
Children's Hospital of Fudan UniversityNot yet recruiting
-
Children's Hospital of Fudan UniversityRecruiting
-
CorrectSequence Therapeutics Co., LtdFirst Affiliated Hospital of Guangxi Medical UniversityCompleted