DepressionNCT04618562
Revival Active Program for Adolescents With Depression
A study testing Revival Active Program in people with Depression, run by Revival Active at 1 site in India.
Trial summary
Active play and sports has shown to be effective intervention in managing depression. Extending the support with Mind body therapy, Revival Active Program was designed as an early intervention for adolescents. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Depression
- What is being tested?
- Revival Active Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteIndia
- Study dates
- 3 Mar 2020to 18 Sep 2020
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed with depression as per the DSM IV-TR criteria
- Parents willing to give written informed consent
Who cannot join
- Physical limitation for active sports
- Co-morbid mental health diagnosis
- high risk of self harm/ suicide
- history of self harm or harming someone else
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Revival Active Program on Adolescents With Depression: A Pilot Study
Active play and sports has shown to be effective intervention in managing depression. Extending the support with Mind body therapy, Revival Active Program was designed as an early intervention for adolescents.
To measure the efficacy and feasibility of the community based revival active play intervention for adolescent depression, present pilot study was undertaken.
- Conditions
- Depression
- Being tested
- Revival Active Program
- Keywords
- Adolescent, Revival Active Program
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revival Active ProgramOther
Program comprised of physical activities, group play, mind games, reasoning and discussion on sleeted topics, breath work and relaxation techniques, 60 minutes all together.
| Study group | Role | What they receive |
|---|---|---|
| Revival Active Program | Experimental | Revival Program included supervised play group, twice a week followed by home practice. Receives: Other: Revival Active Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Children Depression Inventory-II was used to assess depression level
Measured: Changes from baseline depression at 8-week
Secondary outcomes (1)
Self-Efficacy for Children
Emotional, social and academic self efficacy was assessed using Self-Efficacy Questionnaire for Children
Measured: Changes from baseline self -efficacy at 8-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start3 Mar 2020
- Primary completion6 Sep 2020
- Study completion18 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revival Active
- Sponsor type
- University, hospital or other
- Collaborators
- L.E.A.D, NMP Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Rakesh Patel, Study director, Revival Active LimitedTejal Patel, Study director, Revival Active LimitedSadhana Sharma, Study chair, L.E.A.DSahil Signal, Principal investigator, NMP Medical Research Institute, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618562
- Sponsor's protocol ID
- RAP/002
- Status last verified
- Oct 2020
- First submitted
- 28 Oct 2020
- Last updated
- 6 Nov 2020
- 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 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Revival Active Program on Adolescents With Depression: A Pilot Study
- ClinicalTrials.gov ID
- NCT04618562
- Acronym / sponsor ID
- RAP/002
- Conditions
- Depression
- Keywords
- Adolescent, Revival Active Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Revival ActiveUniversity, hospital or other
- Collaborators
- L.E.A.D, NMP Medical Research Institute
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 6 Sep 2020 (actual)
- Study completion
- 18 Sep 2020 (actual)
- First posted
- 6 Nov 2020 (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.
Active play and sports has shown to be effective intervention in managing depression. Extending the support with Mind body therapy, Revival Active Program was designed as an early intervention for adolescents.
To measure the efficacy and feasibility of the community based revival active play intervention for adolescent depression, present pilot study was undertaken.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Revival Active Program | Experimental | Other: Revival Active ProgramRevival Program included supervised play group, twice a week followed by home practice. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children diagnosed with depression as per the DSM IV-TR criteria
- Parents willing to give written informed consent
Key exclusion criteria (4 listed)
- Physical limitation for active sports
- Co-morbid mental health diagnosis
- high risk of self harm/ suicide
- history of self harm or harming someone else
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 |
|---|---|---|
| Revival Active ProgramProgram comprised of physical activities, group play, mind games, reasoning and discussion on sleeted topics, breath work and relaxation techniques, 60 minutes all together. | Other | Revival Active Program |
Primary outcome
Depression
Time frame: Changes from baseline depression at 8-week
Children Depression Inventory-II was used to assess depression level
1 secondary outcome
Self-Efficacy for Children
Time frame: Changes from baseline self -efficacy at 8-week
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 6 Nov 2020.
- 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.
Rakesh Patel study director
Revival Active Limited
Tejal Patel study director
Revival Active Limited
Sadhana Sharma study chair
L.E.A.D
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revival Active Program in people with Depression, run by Revival Active 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 2 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 6 Nov 2020. 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?
Depression (time frame: Changes from baseline depression at 8-week). 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 6 Nov 2020.