TeenThrive: Treatments for Improving Mood in Depressed Teens-3

• Sponsor: Brown University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03831360
• Collaborator: National Center for Complementary and Integrative Health (NCCIH) (NIH), Butler Hospital (Other)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 23.3
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

Phase 3 is a randomized clinical trial of yoga vs group Cognitive Behavioral Therapy (CBT) for adolescents with depression.

Condition or Disease	Intervention/Treatment	Phase
Depression	Behavioral: Yoga; Behavioral: Group CBT	N/A

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

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Adaptation and Pilot Study of Yoga to Reduce Depression in Adolescents
• Actual Study Start Date: Oct 21, 2019
• Actual Primary Completion Date: Sep 29, 2021
• Actual Study Completion Date: Sep 29, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hatha Yoga 12 weeks of hatha yoga	Behavioral: Yoga; Hatha yoga for depressed adolescents
Experimental: Group CBT 12 weeks of group CBT	Behavioral: Group CBT; Group cognitive behavioral therapy for depressed adolescents

Outcome Measures

Primary Outcome Measures

1. Acceptability [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.

2. Credibility Expectancy Questionnaire (CEQ) - Credibility Subscale [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.

3. Credibility Expectancy Questionnaire (CEQ) - Expectancy Subscale [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.

4. The Client Satisfaction Questionnaire (CSQ-8) [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.

5. Home Practice Questionnaire [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.

6. Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE) [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.

Secondary Outcome Measures

1. Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR) [Baseline to post intervention (month 3)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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).

1. 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.

2. 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.

3. Adolescents must be aged 13-18.

4. 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.

5. Adolescents must be able to read and write English sufficient to complete informed consent and engage in interventions.

6. 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.

7. Able to attend one of the class times.

Exclusion Criteria:

Exclusion criteria for Phase 3 Study A, and Phase 3 Study B are identical.

1. QIDS- A-CR may not be higher than a score of 21. This ensures that adolescents are not severely depressed.

2. 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

• 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).

1. Adolescents may not have suicide ideation so severe it will interfere with study participation.

2. Adolescents cannot currently be engaged in yoga classes, as this is the study intervention.

3. Adolescents cannot be pregnant as yoga should be modified for pregnancy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Butler Hospital	Providence	Rhode Island	United States	02906

Sponsors and Collaborators

• Brown University
• National Center for Complementary and Integrative Health (NCCIH)
• Butler Hospital

Investigators

• Principal Investigator: Lisa Uebelacker, PhD, Butler Hospital
• Principal Investigator: Shirley Yen, PhD, Brown University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 10, 2020
• Informed Consent Form - Dec 10, 2020

More Information

Publications

None provided.

• Responsible Party: Brown University
• ClinicalTrials.gov Identifier: NCT03831360
• Other Study ID Numbers: 1801001977; R34AT009886
• First Posted: Feb 5, 2019
• Last Update Posted: Jun 2, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Depression

Study Results

Participant Flow

Arm/Group Title	Hatha Yoga	Group CBT
Arm/Group Description	12 weeks of hatha yoga Yoga: Hatha yoga for depressed adolescents	12 weeks of group CBT Group CBT: Group cognitive behavioral therapy for depressed adolescents
Period Title: Overall Study
STARTED	15	15
COMPLETED	12	14
NOT COMPLETED	3	1

Baseline Characteristics

Arm/Group Title	Hatha Yoga	Group CBT	Total
Arm/Group Description	12 weeks of hatha yoga Yoga: Hatha yoga for depressed adolescents	12 weeks of group CBT Group CBT: Group cognitive behavioral therapy for depressed adolescents	Total of all reporting groups
Overall Participants	15	15	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	15.00 (1.41)	15.00 (1.46)	15.00 (1.40)
Sex: Female, Male (Count of Participants)
Female	12 80%	13 86.7%	25 83.3%
Male	3 20%	2 13.3%	5 16.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 13.3%	3 20%	5 16.7%
Not Hispanic or Latino	13 86.7%	12 80%	25 83.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	1 6.7%	1 3.3%
White	12 80%	11 73.3%	23 76.7%
More than one race	2 13.3%	2 13.3%	4 13.3%
Unknown or Not Reported	1 6.7%	1 6.7%	2 6.7%
Region of Enrollment (Count of Participants)
United States	15 100%	15 100%	30 100%

Outcome Measures

1. Primary Outcome

Title	Acceptability
Description	Acceptability is operationalized by the number of participants who attended 8 or more classes out of possible 12. Target was 70% or greater.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hatha Yoga	Group CBT
Arm/Group Description	12 weeks of hatha yoga Yoga: Hatha yoga for depressed adolescents	12 weeks of group CBT Group CBT: Group cognitive behavioral therapy for depressed adolescents
Measure Participants	15	15
Count of Participants [Participants]	11 73.3%	13 86.7%

2. Primary Outcome

Title	Credibility Expectancy Questionnaire (CEQ) - Credibility Subscale
Description	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.
Time Frame	Week 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hatha Yoga	Group CBT
Arm/Group Description	12 weeks of hatha yoga Yoga: Hatha yoga for depressed adolescents	12 weeks of group CBT Group CBT: Group cognitive behavioral therapy for depressed adolescents
Measure Participants	14	14
Mean (Standard Deviation) [score on a scale]	0.72 (.18)	0.71 (.17)

3. Primary Outcome

Title	Credibility Expectancy Questionnaire (CEQ) - Expectancy Subscale
Description	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.
Time Frame	Week 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hatha Yoga	Group CBT
Arm/Group Description	12 weeks of hatha yoga Yoga: Hatha yoga for depressed adolescents	12 weeks of group CBT Group CBT: Group cognitive behavioral therapy for depressed adolescents
Measure Participants	14	14
Mean (Standard Deviation) [score on a scale]	0.57 (.20)	0.55 (.24)

4. Primary Outcome

Title	The Client Satisfaction Questionnaire (CSQ-8)
Description	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.
Time Frame	Post intervention (month 3)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hatha Yoga	Group CBT
Arm/Group Description	12 weeks of hatha yoga Yoga: Hatha yoga for depressed adolescents	12 weeks of group CBT Group CBT: Group cognitive behavioral therapy for depressed adolescents
Measure Participants	9	13
Mean (Standard Deviation) [score on a scale]	26.8 (4.18)	26.1 (5.00)

5. Primary Outcome

Title	Home Practice Questionnaire
Description	Number of participants who met criteria for home practice (target of two practices per week) as assessed with a home practice questionnaire.
Time Frame	Post intervention (month 3)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hatha Yoga	Group CBT
Arm/Group Description	12 weeks of hatha yoga Yoga: Hatha yoga for depressed adolescents	12 weeks of group CBT Group CBT: Group cognitive behavioral therapy for depressed adolescents
Measure Participants	14	15
Count of Participants [Participants]	3 20%	8 53.3%

6. Primary Outcome

Title	Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)
Description	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.
Time Frame	Post intervention (month 3)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hatha Yoga	Group CBT
Arm/Group Description	12 weeks of hatha yoga Yoga: Hatha yoga for depressed adolescents	12 weeks of group CBT Group CBT: Group cognitive behavioral therapy for depressed adolescents
Measure Participants	14	14
Count of Participants [Participants]	0 0%	0 0%

7. Secondary Outcome

Title	Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR)
Description	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.
Time Frame	Baseline to post intervention (month 3)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hatha Yoga	Group CBT
Arm/Group Description	12 weeks of hatha yoga Yoga: Hatha yoga for depressed adolescents	12 weeks of group CBT Group CBT: Group cognitive behavioral therapy for depressed adolescents
Measure Participants	12	13
Mean (Standard Deviation) [score on a scale]	6.92 (5.20)	8.23 (3.17)

Adverse Events

Time Frame	Three months
Arm/Group Title	Hatha Yoga		Group CBT
Arm/Group Description	12 weeks of hatha yoga Yoga: Hatha yoga for depressed adolescents		12 weeks of group CBT Group CBT: Group cognitive behavioral therapy for depressed adolescents
All Cause Mortality
	Hatha Yoga		Group CBT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Serious Adverse Events
	Hatha Yoga		Group CBT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Hatha Yoga		Group CBT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/15 (6.7%)		2/15 (13.3%)
Immune system disorders
flu	1/15 (6.7%)	1	2/15 (13.3%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.