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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05261230
Other study ID # ANL/GS/001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 21, 2021
Est. completion date February 3, 2022

Study information

Verified date February 2022
Source Active Natural Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date February 3, 2022
Est. primary completion date January 18, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

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.
Standard Care
The active control group received standard psychosocial care provided by the participating psychologists and psychiatrists.

Locations

Country Name City State
India NMP Medical Research Institute Jaipur Rajasthan

Sponsors (2)

Lead Sponsor Collaborator
Active Natural Limited NMP Medical Research Institute

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Symptoms of Depression Depression was measured through Depression Anxiety Stress Scale (DASS)-21 Change from baseline depression at 12-weeks
Secondary Symptom of Stress Stress was measured through Depression Anxiety Stress Scale (DASS)-21 Change from baseline stress at 12-weeks
Secondary 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
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