Treatments for Improving Mood in Depressed Teens-3

NCT ID: NCT03831360

Last Updated: 2022-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-21
• Study Completion Date: 2021-09-29

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hatha Yoga

12 weeks of hatha yoga

Group Type: EXPERIMENTAL

Yoga

Intervention Type: BEHAVIORAL

Hatha yoga for depressed adolescents

Group CBT

12 weeks of group CBT

Group Type: EXPERIMENTAL

Group CBT

Intervention Type: BEHAVIORAL

Group cognitive behavioral therapy for depressed adolescents

Interventions

Yoga

Hatha yoga for depressed adolescents

Intervention Type: BEHAVIORAL

Group CBT

Group cognitive behavioral therapy for depressed adolescents

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

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).

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

4. Adolescents cannot currently be engaged in 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

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Butler Hospital

OTHER

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

Identifier Type: -

Identifier Source: org_study_id