Back to resultsVedic Counselling for Women Victims of Domestic Abuse
Primary Purpose
Intimate Partner Violence, Post Traumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Vedic Counselling
Standard Care
Sponsored by
About this trial
This is an interventional treatment trial for Intimate Partner Violence
Eligibility Criteria
Inclusion Criteria:
- Female survivors of Domestic Abuse
- 18 years old or older
- Sign informed consent
Exclusion Criteria:
- Severe mental illness that requires specialized treatment
- Terminally ill
- Under psychiatric medication
- Chronic illnesses
Sites / Locations
- NMP Medical Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vedic Counselling Group
Usual Care Group
Arm Description
Vedic Counselling was given by trained and experienced therapists
Standard psychosocial care delivered by psychologists.
Outcomes
Primary Outcome Measures
Symptoms of Post-Traumatic Stress Disorders (PTSD)
PTSD symptoms measured by revised version of the Impact of Event Scale (IES-r) 22 questions and a scoring range of 0 to 88
Secondary Outcome Measures
Symptoms of Anxiety
Anxiety was measured through Depression Anxiety Stress Scale (DASS)-21, self-report questionnaire consisting of 21 items, 7 items per subscale: scored 0 to 3 on each item.
Symptoms of Depression
Depression was measured through Depression Anxiety Stress Scale (DASS)-21
Symptom of Stress
Stress was measured through Depression Anxiety Stress Scale (DASS)-21
Self-Esteem
Self-esteem was measured using the Rosenberg's Self-Esteem Scale. Each question response that gives a score between 1-4.
Full Information
NCT ID
NCT05261230
First Posted
February 19, 2022
Last Updated
February 19, 2022
Sponsor
Active Natural Limited
Collaborators
NMP Medical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05261230
Brief Title
Vedic Counselling for Women Victims of Domestic Abuse
Official Title
Trauma Focused Vedic Counselling for Women Victims of Domestic Abuse: Community-based Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 21, 2021 (Actual)
Primary Completion Date
January 18, 2022 (Actual)
Study Completion Date
February 3, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Active Natural Limited
Collaborators
NMP Medical Research Institute
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
The Vedic Counselling is the whole person approach, system of total life style counselling based on 'Vedic Laws of right living, right actions, right relationship and right awareness'.Vedic Counselling was developed as trauma focused therapy for this study to treat female victims of domestic abuse.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intimate Partner Violence, Post Traumatic Stress Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vedic Counselling Group
Arm Type
Experimental
Arm Description
Vedic Counselling was given by trained and experienced therapists
Arm Title
Usual Care Group
Arm Type
Active Comparator
Arm Description
Standard psychosocial care delivered by psychologists.
Intervention Type
Behavioral
Intervention Name(s)
Vedic Counselling
Intervention Description
Trauma focused Vedic Counselling intervention was delivered by trained and experienced therapist of Yoga and Vedanta.12-week sessions were provided on one to one bases on personalised approach.
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
The active control group received standard psychosocial care provided by the participating psychologists and psychiatrists.
Primary Outcome Measure Information:
Title
Symptoms of Post-Traumatic Stress Disorders (PTSD)
Description
PTSD symptoms measured by revised version of the Impact of Event Scale (IES-r) 22 questions and a scoring range of 0 to 88
Time Frame
Change from baseline PTSD symptoms at 12-weeks
Secondary Outcome Measure Information:
Title
Symptoms of Anxiety
Description
Anxiety was measured through Depression Anxiety Stress Scale (DASS)-21, self-report questionnaire consisting of 21 items, 7 items per subscale: scored 0 to 3 on each item.
Time Frame
Change from baseline anxiety at 12-weeks
Title
Symptoms of Depression
Description
Depression was measured through Depression Anxiety Stress Scale (DASS)-21
Time Frame
Change from baseline depression at 12-weeks
Title
Symptom of Stress
Description
Stress was measured through Depression Anxiety Stress Scale (DASS)-21
Time Frame
Change from baseline stress at 12-weeks
Title
Self-Esteem
Description
Self-esteem was measured using the Rosenberg's Self-Esteem Scale. Each question response that gives a score between 1-4.
Time Frame
Change from baseline at 12 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female survivors of Domestic Abuse
18 years old or older
Sign informed consent
Exclusion Criteria:
Severe mental illness that requires specialized treatment
Terminally ill
Under psychiatric medication
Chronic illnesses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sadhana Sharma
Organizational Affiliation
Gyansanjeevani
Official's Role
Principal Investigator
Facility Information:
Facility Name
NMP Medical Research Institute
City
Jaipur
State/Province
Rajasthan
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Vedic Counselling for Women Victims of Domestic Abuse
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