Back to resultsCulturally Sensitive Cognitive Behavioural Therapy for the Survivors of Intimate Partner Violence (IPV)
Primary Purpose
Mental Abuse of Adult, Emotional Abuse, Domestic Violence
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
CS-CBT
CBT
Sponsored by
About this trial
This is an interventional supportive care trial for Mental Abuse of Adult
Eligibility Criteria
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
Sites / Locations
- Gyansaneejvani
- NMP Medical Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CS-CBT
CBT
Arm Description
Culturally sensitive-CBT intervention was comprised of 16 sessions of cognitive behavioral therapy focused on culturally-specific beliefs and attitude.
CBT intervention was comprised of 16 sessions of cognitive behavioral therapy.
Outcomes
Primary Outcome Measures
Psychological symptoms
Brief Symptom Inventory (BSI) was used to assess psychological complaints
Secondary Outcome Measures
Self esteem
Rosenberg Self-Esteem Scale was used to assess self esteem
Forgiveness
Heartland Forgiveness Scale was used to assess forgiveness to oneself, to other and to situation
Full Information
NCT ID
NCT04105933
First Posted
September 25, 2019
Last Updated
October 24, 2019
Sponsor
NMP Medical Research Institute
Collaborators
Warwick Research Services
1. Study Identification
Unique Protocol Identification Number
NCT04105933
Brief Title
Culturally Sensitive Cognitive Behavioural Therapy for the Survivors of Intimate Partner Violence (IPV)
Official Title
The Effects of Culturally Sensitive Cognitive Behavioural Therapy on Women Experienced Intimate Partner Violence
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 12, 2017 (Actual)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
February 11, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NMP Medical Research Institute
Collaborators
Warwick Research Services
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. Present study developed Culturally sensitive cognitive-behaviour therapy (CBT) to fit the client's cultural identity, context, and preferences.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Abuse of Adult, Emotional Abuse, Domestic Violence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CS-CBT
Arm Type
Experimental
Arm Description
Culturally sensitive-CBT intervention was comprised of 16 sessions of cognitive behavioral therapy focused on culturally-specific beliefs and attitude.
Arm Title
CBT
Arm Type
Active Comparator
Arm Description
CBT intervention was comprised of 16 sessions of cognitive behavioral therapy.
Intervention Type
Other
Intervention Name(s)
CS-CBT
Intervention Description
Culturally sensitive Cognitive Behavioural Therapy was delivered individually, focused on potential cultural beliefs and attitudes that might collide with core values of CBT.
Intervention Type
Other
Intervention Name(s)
CBT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Psychological symptoms
Description
Brief Symptom Inventory (BSI) was used to assess psychological complaints
Time Frame
Change from baseline to 16 weeks
Secondary Outcome Measure Information:
Title
Self esteem
Description
Rosenberg Self-Esteem Scale was used to assess self esteem
Time Frame
Change from baseline to 16 weeks
Title
Forgiveness
Description
Heartland Forgiveness Scale was used to assess forgiveness to oneself, to other and to situation
Time Frame
Change from baseline to 16 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neha Sharma, PhD
Organizational Affiliation
Warwick Research Services
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rachana Khandelwal, PhD
Organizational Affiliation
NMP Medical Research Institute, India
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anurag Sharma, MPhil
Organizational Affiliation
Patan Girls College, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gyansaneejvani
City
Bundi
State/Province
Rajasthan
Country
India
Facility Name
NMP Medical Research Institute
City
Jaipur
State/Province
Rajasthan
Country
India
12. IPD Sharing Statement
Learn more about this trial
Culturally Sensitive Cognitive Behavioural Therapy for the Survivors of Intimate Partner Violence (IPV)
We'll reach out to this number within 24 hrs