Vedic Counselling for Women Victims of Domestic Abuse

Study Overview
=================
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.

Official Title
-----------------
Trauma Focused Vedic Counselling for Women Victims of Domestic Abuse: Community-based Pilot Study.

Conditions
-----------------
Intimate Partner Violence, Post Traumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: Vedic Counselling
* Behavioral: Standard Care


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vedic Counselling Group<br>Vedic Counselling was given by trained and experienced therapists | Behavioral: Vedic Counselling<br>* 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.<br>|
| Active Comparator: Usual Care Group<br>Standard psychosocial care delivered by psychologists. | Behavioral: Standard Care<br>* The active control group received standard psychosocial care provided by the participating psychologists and psychiatrists.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Change from baseline PTSD symptoms at 12-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline anxiety at 12-weeks | 
| Symptoms of Depression | Depression was measured through Depression Anxiety Stress Scale (DASS)-21 | Change from baseline depression at 12-weeks | 
| Symptom of Stress | Stress was measured through Depression Anxiety Stress Scale (DASS)-21 | Change from baseline stress at 12-weeks | 
| Self-Esteem | Self-esteem was measured using the Rosenberg's Self-Esteem Scale. Each question response that gives a score between 1-4. | Change from baseline at 12 weeks |