Treatments for Improving Mood in Depressed Teens-2

NCT ID: NCT03831347

Last Updated: 2022-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2019-08-29

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.

Conditions

Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hatha Yoga

12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression.

Group Type: EXPERIMENTAL

Hatha Yoga

Intervention Type: BEHAVIORAL

12 weeks of Hatha Yoga

Interventions

Hatha Yoga

12 weeks of Hatha Yoga

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Butler Hospital

OTHER

Sponsor Role: collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Uebelacker, PhD

Role: PRINCIPAL_INVESTIGATOR

Butler Hospital

Shirley Yen, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

Butler Hospital

Providence, Rhode Island, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R34AT009886

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1801001977 Open

Identifier Type: -

Identifier Source: org_study_id