Depression
Conditions
Brief summary
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.
Interventions
BEHAVIORALHatha Yoga
12 weeks of Hatha Yoga
Sponsors
Butler Hospital
National Center for Complementary and Integrative Health (NCCIH)
Brown University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 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 12 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
1. QIDS- A-CR may not be higher than a score of 21. This ensures that adolescents are not severely depressed. 2. 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; * 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). 3. 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. 4. Adolescents cannot currently be engaged in or yoga classes, as this is the study intervention. 5. Adolescents cannot be pregnant as yoga should be modified for pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 with higher scores indicating greater expectations. |
| Acceptability | Post intervention (month 3) | Acceptability assessed based on number of participants who remained in the intervention (retention). |
| 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 scored on a range of 0-1. Higher scores indicate greater credibility. |
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR) | post intervention (month 3) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hatha Yoga 12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression.
Hatha Yoga: 12 weeks of Hatha Yoga | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Hatha Yoga |
|---|---|
| Age, Continuous | 15.8 years STANDARD_DEVIATION 1.8 |
| Race/Ethnicity, Customized Multiracial and Other | 2 Participants |
| Race/Ethnicity, Customized White | 9 Participants |
| Region of Enrollment United States | 11 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 2 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Acceptability
Acceptability assessed based on number of participants who remained in the intervention (retention).
Time frame: Post intervention (month 3)
Population: Entire sample
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hatha Yoga | Acceptability | 9 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 scored on a range of 0-1. Higher scores indicate greater credibility.
Time frame: Week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hatha Yoga | Credibility Expectancy Questionnaire (CEQ) - Credibility Subscale | 0.76 score on a scale | Standard Deviation 0.25 |
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 with higher scores indicating greater expectations.
Time frame: Week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hatha Yoga | Credibility Expectancy Questionnaire (CEQ) - Expectancy Subscale | 0.66 score on a scale | Standard Deviation 0.29 |
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 | 6 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 (NUMBER) |
|---|---|---|
| Hatha Yoga | Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE) | 6 adverse events |
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) | 26.2 score on a scale | Standard Deviation 6.1 |
Secondary
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.
Time frame: post intervention (month 3)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hatha Yoga | Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR) | 4.11 score on a scale | Standard Deviation 2.66 |