Depression
Conditions
Brief summary
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.
Interventions
BEHAVIORALYoga
Hatha yoga for depressed adolescents
BEHAVIORALGroup CBT
Group cognitive behavioral therapy for depressed adolescents
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Butler Hospital
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hatha Yoga 12 weeks of hatha yoga
Yoga: Hatha yoga for depressed adolescents | 15 |
| Group CBT 12 weeks of group CBT
Group CBT: Group cognitive behavioral therapy for depressed adolescents | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Hatha Yoga | Total | Group CBT |
|---|---|---|---|
| Age, Continuous | 15.00 years STANDARD_DEVIATION 1.41 | 15.00 years STANDARD_DEVIATION 1.4 | 15.00 years STANDARD_DEVIATION 1.46 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 25 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 12 Participants | 23 Participants | 11 Participants |
| Region of Enrollment United States | 15 Participants | 30 Participants | 15 Participants |
| Sex: Female, Male Female | 12 Participants | 25 Participants | 13 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 1 / 15 | 2 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Acceptability
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hatha Yoga | Acceptability | 11 Participants |
| Group CBT | Acceptability | 13 Participants |
Primary
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.
Time frame: Week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hatha Yoga | Credibility Expectancy Questionnaire (CEQ) - Credibility Subscale | 0.72 score on a scale | Standard Deviation 0.18 |
| Group CBT | Credibility Expectancy Questionnaire (CEQ) - Credibility Subscale | 0.71 score on a scale | Standard Deviation 0.17 |
Primary
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.
Time frame: Week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hatha Yoga | Credibility Expectancy Questionnaire (CEQ) - Expectancy Subscale | 0.57 score on a scale | Standard Deviation 0.2 |
| Group CBT | Credibility Expectancy Questionnaire (CEQ) - Expectancy Subscale | 0.55 score on a scale | Standard Deviation 0.24 |
Primary
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.
Time frame: Post intervention (month 3)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hatha Yoga | Home Practice Questionnaire | 3 Participants |
| Group CBT | Home Practice Questionnaire | 8 Participants |
Primary
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.
Time frame: Post intervention (month 3)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hatha Yoga | Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE) | 0 Participants |
| Group CBT | Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE) | 0 Participants |
Primary
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.
Time frame: Post intervention (month 3)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hatha Yoga | The Client Satisfaction Questionnaire (CSQ-8) | 26.8 score on a scale | Standard Deviation 4.18 |
| Group CBT | The Client Satisfaction Questionnaire (CSQ-8) | 26.1 score on a scale | Standard Deviation 5 |
Secondary
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.
Time frame: Baseline to post intervention (month 3)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hatha Yoga | Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR) | 6.92 score on a scale | Standard Deviation 5.2 |
| Group CBT | Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR) | 8.23 score on a scale | Standard Deviation 3.17 |