DepressionTeenThriveNCT03831347
Treatments for Improving Mood in Depressed Teens-2
A study testing Hatha Yoga in people with Depression, run by Brown University at 1 site in United States.
Trial summary
Phase 2: Open Trial N=12 adolescents will be enrolled into a single-arm pilot trial to test the adapted hatha yoga intervention Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Depression
- What is being tested?
- Hatha Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 29 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents must have elevated depressive symptoms, defined by a score of 11 or higher on the Quick Inventory of Depression -Adolescent Version-- Clinician Rating (QIDS-A-CR), including endorsement of either sad mood or anhedonia on the QIDS.
- Other treatment for depression must be stable at baseline. Adolescents do not have to be in other treatment for depression, but, if they are, it must be stable for the past 12 weeks.
- Adolescents must be aged 13-18.
- Adolescents must be medically cleared for moderate physical activity by their primary care physician. This criterion may be met by a current (dated in the past year) statement from their pediatrician that the adolescent may participate in school or camp programs including physical education.
- Adolescents must be able to read and write English sufficient to complete informed consent and engage in interventions.
- Adolescents aged 13-17 must assent to be in the study, and their parent or legal guardian must consent to their participation. Adolescents aged 18 must consent to be in the study.
- Able to attend one of the class times.
Who cannot join
- QIDS- A-CR may not be higher than a score of 21. This ensures that adolescents are not severely depressed.
- Adolescents who meet criteria for:
- Current (past year) autism spectrum disorder (AS), if of sufficient severity to interfere with study treatment per clinician judgment;
- Schizophrenia;
- Bipolar disorder;
- Clinically significant psychotic symptoms in the past month;
Show all 11Show fewer
- Anorexia or Bulimia in past 3 months
- Substance use disorders in the past 12 months and symptoms are of sufficient severity to interfere with study treatment per clinician judgment These will be assessed with the Mini-International Neuropsychiatric Interview (MINI).
- Adolescents may not have current suicide ideation or behavior that warrants immediate treatment. They may have passive ideation (i.e., thoughts that life is not worth living), but may not have active suicide ideation, intent, plan, or an attempt within the previous 6 months.
- Adolescents cannot currently be engaged in or yoga classes, as this is the study intervention.
- Adolescents cannot be pregnant as yoga should be modified for pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptation and Pilot Study of Yoga to Reduce Depression in Adolescents
Phase 2: Open Trial N=12 adolescents will be enrolled into a single-arm pilot trial to test the adapted hatha yoga intervention
Read the detailed description
In Phase 2, the investigators will conduct an open single-arm pilot trial of our 12 week adapted hatha yoga intervention.
the investigators will enroll 12 adolescents in the open pilot trial.
- Conditions
- Depression
- Being tested
- Hatha Yoga
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hatha YogaBehavioural
12 weeks of Hatha Yoga
| Study group | Role | What they receive |
|---|---|---|
| Hatha Yoga | Experimental | 12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression. Receives: Behavioral: Hatha Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Acceptability assessed based on number of participants who remained in the intervention (retention).
Measured: Post intervention (month 3)
Credibility Expectancy Questionnaire (CEQ) - Credibility Subscale
Credibility assessed with Credibility Expectancy Questionnaire (CEQ), credibility subscale. The credibility subscale of the CEQ, is a 3 item subscale of the 6 item CEQ. The 3 items are scored on a range of 0-1. Higher scores indicate greater credibility.
Measured: Week 1
Credibility Expectancy Questionnaire (CEQ) - Expectancy Subscale
Patient expectations assessed with the Credibility Expectancy Questionnaire (CEQ), expectancy subscale. The expectancy subscale is a 3 item subscale of the 6 item CEQ. Score ranges from 0-1 with higher scores indicating greater expectations.
Measured: Week 1
The Client Satisfaction Questionnaire (CSQ-8)
Satisfaction with treatment assessed with The Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item measure with each item measured on a 1-4 scale, and total score range from 8-32. Higher scores indicate greater client satisfaction.
Measured: Post intervention (month 3)
Home Practice Questionnaire
Number of participants who met criteria for home practice (target of two practices per week) as assessed with a home practice questionnaire.
Measured: Post intervention (month 3)
Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)
Participant safety/adverse events will be measured using the SAFTEE. Participants will also be asked weekly if they experienced any injuries as a result of yoga.
Measured: Post intervention (month 3)
Secondary outcomes (1)
Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR)
Depression symptom severity at Month 3. The QIDS is a 17 item measure with scores ranging from 0-30. Higher scores indicate greater depressive symptoms.
Measured: post intervention (month 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start1 Mar 2019
- Primary completion14 Aug 2019
- Study completion29 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Butler Hospital, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Lisa Uebelacker, PhD, Principal investigator, Butler HospitalShirley Yen, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831347
- Sponsor's protocol ID
- 1801001977 Open
- Other IDs
- R34AT009886
- Acronym
- TeenThrive
- Status last verified
- Feb 2022
- First submitted
- 30 Jan 2019
- Last updated
- 23 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD underlying publication if required by journal.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Pilot Study of Yoga to Reduce Depression in Adolescents
- ClinicalTrials.gov ID
- NCT03831347
- Acronym / sponsor ID
- TeenThrive / 1801001977 Open
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Butler Hospital, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 14 Aug 2019 (actual)
- Study completion
- 29 Aug 2019 (actual)
- First posted
- 5 Feb 2019 (actual)
- Results
- Posted 23 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2: Open Trial N=12 adolescents will be enrolled into a single-arm pilot trial to test the adapted hatha yoga intervention
Detailed description
In Phase 2, the investigators will conduct an open single-arm pilot trial of our 12 week adapted hatha yoga intervention.
the investigators will enroll 12 adolescents in the open pilot trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hatha Yoga | Experimental | Behavioral: Hatha Yoga12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Adolescents must have elevated depressive symptoms, defined by a score of 11 or higher on the Quick Inventory of Depression -Adolescent Version-- Clinician Rating (QIDS-A-CR), including endorsement of either sad mood or anhedonia on the QIDS.
- Other treatment for depression must be stable at baseline. Adolescents do not have to be in other treatment for depression, but, if they are, it must be stable for the past 12 weeks.
- Adolescents must be aged 13-18.
- Adolescents must be medically cleared for moderate physical activity by their primary care physician. This criterion may be met by a current (dated in the past year) statement from their pediatrician that the adolescent may participate in school or camp programs including physical education.
- Adolescents must be able to read and write English sufficient to complete informed consent and engage in interventions.
Key exclusion criteria (11 listed)
- QIDS- A-CR may not be higher than a score of 21. This ensures that adolescents are not severely depressed.
- Adolescents who meet criteria for:
- Adolescents may not have current suicide ideation or behavior that warrants immediate treatment. They may have passive ideation (i.e., thoughts that life is not worth living), but may not have active suicide ideation, intent, plan, or an attempt within the previous 6 months.
- Adolescents cannot currently be engaged in or yoga classes, as this is the study intervention.
- Adolescents cannot be pregnant as yoga should be modified for pregnancy
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 |
|---|---|---|
| Hatha Yoga12 weeks of Hatha Yoga | Behavioural | Hatha Yoga |
Primary outcome
Acceptability
Time frame: Post intervention (month 3)
Acceptability assessed based on number of participants who remained in the intervention (retention).
Credibility Expectancy Questionnaire (CEQ) - Credibility Subscale
Time frame: Week 1
Credibility assessed with Credibility Expectancy Questionnaire (CEQ), credibility subscale. The credibility subscale of the CEQ, is a 3 item subscale of the 6 item CEQ. The 3 items are scored on a range of 0-1. Higher scores indicate greater credibility.
Credibility Expectancy Questionnaire (CEQ) - Expectancy Subscale
Time frame: Week 1
Patient expectations assessed with the Credibility Expectancy Questionnaire (CEQ), expectancy subscale. The expectancy subscale is a 3 item subscale of the 6 item CEQ. Score ranges from 0-1 with higher scores indicating greater expectations.
The Client Satisfaction Questionnaire (CSQ-8)
Time frame: Post intervention (month 3)
Satisfaction with treatment assessed with The Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item measure with each item measured on a 1-4 scale, and total score range from 8-32. Higher scores indicate greater client satisfaction.
Home Practice Questionnaire
Time frame: Post intervention (month 3)
Number of participants who met criteria for home practice (target of two practices per week) as assessed with a home practice questionnaire.
Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)
Time frame: Post intervention (month 3)
Participant safety/adverse events will be measured using the SAFTEE. Participants will also be asked weekly if they experienced any injuries as a result of yoga.
1 secondary outcome
Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR)
Time frame: post intervention (month 3)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All IPD underlying publication if required by journal.
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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.
Lisa Uebelacker, PhD principal investigator
Butler Hospital
Shirley Yen, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hatha Yoga in people with Depression, run by Brown University at 1 site in United States.
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 7 inclusion and 11 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 23 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 United States. 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?
Yes. Results are posted in the registry (first posted 23 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Acceptability (time frame: Post intervention (month 3)). The study lists 6 primary outcomes in all. 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 23 Mar 2022.