Vedic Counselling for Women Victims of Domestic Abuse

February 19, 2022 updated by: Active Natural Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

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

  • India
    • Rajasthan
      • 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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms of Post-Traumatic Stress Disorders (PTSD)
Time Frame: Change from baseline PTSD symptoms at 12-weeks
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
Time Frame: Change from baseline anxiety at 12-weeks
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
Time Frame: Change from baseline depression at 12-weeks
Depression was measured through Depression Anxiety Stress Scale (DASS)-21
Change from baseline depression at 12-weeks
Symptom of Stress
Time Frame: Change from baseline stress at 12-weeks
Stress was measured through Depression Anxiety Stress Scale (DASS)-21
Change from baseline stress at 12-weeks
Self-Esteem
Time Frame: Change from baseline at 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Active Natural Limited

Collaborators

NMP Medical Research Institute

Investigators

  • Principal Investigator: Sadhana Sharma, Gyansanjeevani

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)

October 21, 2021

Primary Completion (Actual)

January 18, 2022

Study Completion (Actual)

February 3, 2022

Study Registration Dates

First Submitted

February 19, 2022

First Submitted That Met QC Criteria

February 19, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 19, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANL/GS/001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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