Vedic Counselling for Women Victims of Domestic Abuse

Sponsor

Active Natural Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT05261230

Collaborator

NMP Medical Research Institute (Other)

Enrollment

Location

Arms

3.4

Actual Duration (Months)

19.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Intimate Partner Violence Post Traumatic Stress Disorder	Behavioral: Vedic Counselling Behavioral: Standard Care	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 21, 2021

Actual Primary Completion Date :

Jan 18, 2022

Actual Study Completion Date :

Feb 3, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Symptoms of Post-Traumatic Stress Disorders (PTSD) [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

Secondary Outcome Measures

Symptoms of Anxiety [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.
Symptoms of Depression [Change from baseline depression at 12-weeks]
Depression was measured through Depression Anxiety Stress Scale (DASS)-21
Symptom of Stress [Change from baseline stress at 12-weeks]
Stress was measured through Depression Anxiety Stress Scale (DASS)-21
Self-Esteem [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NMP Medical Research Institute	Jaipur	Rajasthan	India

Sponsors and Collaborators

Active Natural Limited
NMP Medical Research Institute

Investigators

Principal Investigator: Sadhana Sharma, Gyansanjeevani

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Active Natural Limited

ClinicalTrials.gov Identifier:

NCT05261230

Other Study ID Numbers:

ANL/GS/001

First Posted:

Mar 2, 2022

Last Update Posted:

Mar 2, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stress Disorders, Traumatic

Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Mar 2, 2022