Treatments for Improving Mood in Depressed Teens-3

NCT03831360 | Completed Results DMC

• 2 other identifiers: 1801001977R34AT009886
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 3 is a randomized clinical trial of yoga vs group Cognitive Behavioral Therapy (CBT) for adolescents with depression.

Conditions

Depression

Outcome Measures

Primary Outcomes (6)

• Acceptability

  Acceptability is operationalized by the number of participants who attended 8 or more classes out of possible 12. Target was 70% or greater.

  12 weeks

• 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 each scored on a range of 0-1, and the mean of thise is used in analyses. 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 and the mean of those scores are analyzed, 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)

  Baseline to post intervention (month 3)

Study Arms (2)

Hatha Yoga

EXPERIMENTAL

12 weeks of hatha yoga

Behavioral: Yoga

Group CBT

EXPERIMENTAL

12 weeks of group CBT

Behavioral: Group CBT

Interventions

Yoga BEHAVIORAL

Hatha yoga for depressed adolescents

Hatha Yoga

Group CBT BEHAVIORAL

Group cognitive behavioral therapy for depressed adolescents

Group CBT

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 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.
• 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.
• 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 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).
• Adolescents may not have suicide ideation so severe it will interfere with study participation.
• Adolescents cannot currently be engaged in yoga classes, as this is the study intervention.
• Adolescents cannot be pregnant as yoga should be modified for pregnancy.

Sponsors & Collaborators

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

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Yoga

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Results Point of Contact

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

LUebelacker@butler.org

401-455-6381

Study Officials

• Lisa Uebelacker, PhD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

• Shirley Yen, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 5, 2019
• Study Start: October 21, 2019
• Primary Completion: September 29, 2021
• Study Completion: September 29, 2021
• Last Updated: June 2, 2022
• Results First Posted: June 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: upon study completion
• Access Criteria: PIs will review requests for IPD.

Locations

US (1)