DepressionTeenThriveNCT03831360
Treatments for Improving Mood in Depressed Teens-3
A study testing Yoga and Group CBT in people with Depression, run by Brown University at 1 site in United States.
Trial summary
Phase 3 is a randomized clinical trial of yoga vs group Cognitive Behavioral Therapy (CBT) for adolescents with depression. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Depression
- What is being tested?
- Yoga and Group CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2019to 29 Sep 2021
- 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
- Please note, inclusion criteria for Phase 3 Study A, and Phase 3 Study B are identical, with the exception that, for Phase 3/ Study B, we will not require elevated depressive symptoms (a) or stable treatment (b).
- Adolescents must have elevated depressive symptoms, defined by a score of 10 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 8 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
- Exclusion criteria for Phase 3 Study A, and Phase 3 Study B are identical.
- QIDS- A-CR may not be higher than a score of 21. This ensures that adolescents are not severely depressed.
- Adolescents may not meet criteria for the following:
- Autism spectrum disorder "cannot be ruled out", and symptoms are of sufficient severity to interfere with study treatment per clinician judgement
- Current psychotic disorder
- Lifetime history of a manic episode
Show all 11Show fewer
- Anorexia or Bulimia in past 3 months
- Substance use disorders in 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 suicide ideation so severe it will interfere with study participation.
- Adolescents cannot currently be engaged in 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 3 is a randomized clinical trial of yoga vs group Cognitive Behavioral Therapy (CBT) for adolescents with depression.
Read the detailed description
In Phase 3, Study A, the investigators will conduct a pilot Randomized Control Trial (RCT) of 12 weeks of hatha yoga vs. 12 weeks of group CBT.
Participants will be adolescents with depression. Parents will also be invited to participate in assessments regarding their child.
Study B, which will run concurrent to Phase 3, will be for participants who did not meet the depression inclusion criteria or had recent changes in therapy or medications that make them ineligible for Phase 3. Their data will not be analyzed. They are recruited only for group participation.
Participants will be randomized to Phase 3 groups of 12 weeks of hatha yoga or group CBT. Parents will also be invited to participate in assessments regarding their child.
- Due to social distancing requirements related to COVID-19, all interventions have been delivered remotely via video-based platforms as of late March 2020.
- Conditions
- Depression
- Being tested
- Yoga, Group CBT
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
Hatha yoga for depressed adolescents
Group CBTBehavioural
Group cognitive behavioral therapy for depressed adolescents
| Study group | Role | What they receive |
|---|---|---|
| Hatha Yoga | Experimental | 12 weeks of hatha yoga Receives: Behavioral: Yoga |
| Group CBT | Experimental | 12 weeks of group CBT Receives: Behavioral: Group CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Acceptability is operationalized by the number of participants who attended 8 or more classes out of possible 12. Target was 70% or greater.
Measured: 12 weeks
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 each scored on a range of 0-1, and the mean of thise is used in analyses. 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 and the mean of those scores are analyzed, 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)
Change in depression symptom severity will be assessed via blind evaluator using the the QIDS. The QIDS is a 17 item measure with scores ranging from 0-30. Higher scores indicate greater depressive symptoms.
Measured: Baseline to 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 start21 Oct 2019
- Primary completion29 Sep 2021
- Study completion29 Sep 2021
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Butler Hospital
- Responsible party
- Sponsor
- Investigators
- Lisa Uebelacker, PhD, Principal investigator, Butler HospitalShirley Yen, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831360
- Sponsor's protocol ID
- 1801001977
- Other IDs
- R34AT009886
- Acronym
- TeenThrive
- Status last verified
- May 2022
- First submitted
- 30 Jan 2019
- Last updated
- 2 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be made available to other researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 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
- NCT03831360
- Acronym / sponsor ID
- TeenThrive / 1801001977
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Butler Hospital
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 5 Feb 2019 (actual)
- Results
- Posted 2 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 3 is a randomized clinical trial of yoga vs group Cognitive Behavioral Therapy (CBT) for adolescents with depression.
Detailed description
In Phase 3, Study A, the investigators will conduct a pilot Randomized Control Trial (RCT) of 12 weeks of hatha yoga vs. 12 weeks of group CBT.
Participants will be adolescents with depression. Parents will also be invited to participate in assessments regarding their child.
Study B, which will run concurrent to Phase 3, will be for participants who did not meet the depression inclusion criteria or had recent changes in therapy or medications that make them ineligible for Phase 3. Their data will not be analyzed. They are recruited only for group participation.
Participants will be randomized to Phase 3 groups of 12 weeks of hatha yoga or group CBT. Parents will also be invited to participate in assessments regarding their child.
- Due to social distancing requirements related to COVID-19, all interventions have been delivered remotely via video-based platforms as of late March 2020.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hatha Yoga | Experimental | Behavioral: Yoga12 weeks of hatha yoga |
| Group CBT | Experimental | Behavioral: Group CBT12 weeks of group CBT |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Please note, inclusion criteria for Phase 3 Study A, and Phase 3 Study B are identical, with the exception that, for Phase 3/ Study B, we will not require elevated depressive symptoms (a) or stable treatment (b).
- Adolescents must have elevated depressive symptoms, defined by a score of 10 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 8 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.
Key exclusion criteria (11 listed)
- Exclusion criteria for Phase 3 Study A, and Phase 3 Study B are identical.
- QIDS- A-CR may not be higher than a score of 21. This ensures that adolescents are not severely depressed.
- Adolescents may not meet criteria for the following:
- Adolescents may not have suicide ideation so severe it will interfere with study participation.
- Adolescents cannot currently be engaged in yoga classes, as this is the study intervention.
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 |
|---|---|---|
| YogaHatha yoga for depressed adolescents | Behavioural | Hatha Yoga |
| Group CBTGroup cognitive behavioral therapy for depressed adolescents | Behavioural | Group CBT |
Primary outcome
Acceptability
Time frame: 12 weeks
Acceptability is operationalized by the number of participants who attended 8 or more classes out of possible 12. Target was 70% or greater.
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 each scored on a range of 0-1, and the mean of thise is used in analyses. 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 and the mean of those scores are analyzed, 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: Baseline to 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 2 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. IPD will be made available to other researchers upon request.
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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 Yoga and Group CBT 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 8 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 2 Jun 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 2 Jun 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: 12 weeks). 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 2 Jun 2022.