Treatments for Improving Mood in Depressed Teens-2

Depression Clinical Trial

— TeenThrive  

Official title:

Adaptation and Pilot Study of Yoga to Reduce Depression in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03831347
• Other study ID #: 1801001977 Open
• Secondary ID: R34AT009886
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: August 29, 2019

Study information

• Verified date: February 2022
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: August 29, 2019
• Est. primary completion date: August 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression

Intervention

Behavioral:
• Hatha Yoga
12 weeks of Hatha Yoga

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
Brown University	Butler Hospital, National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability	Acceptability assessed based on number of participants who remained in the intervention (retention).	Post intervention (month 3)
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.	Week 1
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.	Week 1
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.	Post intervention (month 3)
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.	Post intervention (month 3)
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.	Post intervention (month 3)
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.	post intervention (month 3)