Intimate Partner ViolenceNCT05261230
Vedic Counselling for Women Victims of Domestic Abuse
A study testing Vedic Counselling in people with Intimate Partner Violence and Post Traumatic Stress Disorder, run by Active Natural Limited at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intimate Partner Violence, Post Traumatic Stress Disorder
- What is being tested?
- Vedic Counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteIndia
- Study dates
- 21 Oct 2021to 3 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female survivors of Domestic Abuse
- 18 years old or older
- Sign informed consent
Who cannot join
- Severe mental illness that requires specialized treatment
- Terminally ill
- Under psychiatric medication
- Chronic illnesses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Vedic Counselling, Standard Care
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vedic CounsellingBehavioural
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 CareBehavioural
The active control group received standard psychosocial care provided by the participating psychologists and psychiatrists.
| Study group | Role | What they receive |
|---|---|---|
| Vedic Counselling Group | Experimental | Vedic Counselling was given by trained and experienced therapists Receives: Behavioral: Vedic Counselling |
| Usual Care Group | Active comparator | Standard psychosocial care delivered by psychologists. Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline PTSD symptoms at 12-weeks
Secondary outcomes (4)
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.
Measured: Change from baseline anxiety at 12-weeks
Symptoms of Depression
Depression was measured through Depression Anxiety Stress Scale (DASS)-21
Measured: Change from baseline depression at 12-weeks
Symptom of Stress
Stress was measured through Depression Anxiety Stress Scale (DASS)-21
Measured: 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.
Measured: Change from baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start21 Oct 2021
- Primary completion18 Jan 2022
- Study completion3 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intimate Partner ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Active Natural Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NMP Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Sadhana Sharma, Principal investigator, Gyansanjeevani
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261230
- Sponsor's protocol ID
- ANL/GS/001
- Status last verified
- Feb 2022
- First submitted
- 19 Feb 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma Focused Vedic Counselling for Women Victims of Domestic Abuse: Community-based Pilot Study.
- ClinicalTrials.gov ID
- NCT05261230
- Acronym / sponsor ID
- ANL/GS/001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Active Natural LimitedIndustry (pharma, biotech, devices)
- Collaborators
- NMP Medical Research Institute
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- 3 Feb 2022 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vedic Counselling Group | Experimental | Behavioral: Vedic CounsellingVedic Counselling was given by trained and experienced therapists |
| Usual Care Group | Active comparator | Behavioral: Standard CareStandard psychosocial care delivered by psychologists. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female survivors of Domestic Abuse
- 18 years old or older
- Sign informed consent
Key exclusion criteria (4 listed)
- Severe mental illness that requires specialized treatment
- Terminally ill
- Under psychiatric medication
- Chronic illnesses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vedic CounsellingTrauma 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. | Behavioural | Vedic Counselling Group |
| Standard CareThe active control group received standard psychosocial care provided by the participating psychologists and psychiatrists. | Behavioural | Usual Care Group |
Primary outcome
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
4 secondary outcomes
Symptoms of Anxiety
Time frame: Change from baseline anxiety at 12-weeks
Symptoms of Depression
Time frame: Change from baseline depression at 12-weeks
Symptom of Stress
Time frame: Change from baseline stress at 12-weeks
Self-Esteem
Time frame: Change from baseline at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sadhana Sharma principal investigator
Gyansanjeevani
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vedic Counselling in people with Intimate Partner Violence and Post Traumatic Stress Disorder, run by Active Natural Limited at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of Post-Traumatic Stress Disorders (PTSD) (time frame: Change from baseline PTSD symptoms at 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.