NCT05261230

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 21, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

3 months

First QC Date

February 19, 2022

Last Update Submit

February 19, 2022

Conditions

Intimate Partner ViolencePost Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Symptoms of Anxiety

    Change from baseline anxiety at 12-weeks

  • Symptoms of Depression

    Change from baseline depression at 12-weeks

  • Symptom of Stress

    Change from baseline stress at 12-weeks

  • Self-Esteem

    Change from baseline at 12 weeks

Study Arms (2)

Vedic Counselling Group

EXPERIMENTAL

Vedic Counselling was given by trained and experienced therapists

Behavioral: Vedic Counselling

Usual Care Group

ACTIVE COMPARATOR

Standard psychosocial care delivered by psychologists.

Behavioral: Standard Care

Interventions

Vedic CounsellingBEHAVIORAL

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.

Vedic Counselling Group
Standard CareBEHAVIORAL

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

Usual Care Group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female survivors of Domestic Abuse
  • years old or older
  • Sign informed consent

You may not qualify if:

  • Severe mental illness that requires specialized treatment
  • Terminally ill
  • Under psychiatric medication
  • Chronic illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NMP Medical Research Institute

Jaipur, Rajasthan, India

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Sadhana Sharma

    Gyansanjeevani

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2022

First Posted

March 2, 2022

Study Start

October 21, 2021

Primary Completion

January 18, 2022

Study Completion

February 3, 2022

Last Updated

March 2, 2022

Record last verified: 2022-02

Locations

IN(1)