Treatments for Improving Mood in Depressed Teens-2

NCT03831347 | Completed Results DMC

• 2 other identifiers: 1801001977 OpenR34AT009886
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Conditions

Depression

Outcome Measures

Primary Outcomes (6)

• Acceptability

  Acceptability assessed based on number of participants who remained in the intervention (retention).

  Post intervention (month 3)

• 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

• 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

• 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)

• 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)

• 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 Outcomes (1)

• Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR)

  post intervention (month 3)

Study Arms (1)

Hatha Yoga

EXPERIMENTAL

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

Behavioral: Hatha Yoga

Interventions

Hatha Yoga BEHAVIORAL

12 weeks of Hatha Yoga

Hatha Yoga

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.
• Adolescents must be aged 13-18.
• 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.
• Adolescents must be able to read and write English sufficient to complete informed consent and engage in interventions.
• 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.
• Able to attend one of the class times.

You may not qualify if:

• QIDS- A-CR may not be higher than a score of 21. This ensures that adolescents are not severely depressed.
• 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).
• 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.
• Adolescents cannot currently be engaged in or yoga classes, as this is the study intervention.
• Adolescents cannot be pregnant as yoga should be modified for pregnancy

Sponsors & Collaborators

• Brown University: lead
• Butler Hospital: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Lisa Uebelacker
• Organization: Butler Hospital

LUebelacker@butler.org

401-455-6200

Study Officials

• Lisa Uebelacker, PhD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

• Shirley Yen, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 5, 2019
• Study Start: March 1, 2019
• Primary Completion: August 14, 2019
• Study Completion: August 29, 2019
• Last Updated: March 23, 2022
• Results First Posted: March 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: One year after study collection.
• Access Criteria: Information available upon request, please send to PIs Lisa Uebelacker or Shirley Yen.

Locations

US (1)