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Treatments for Improving Mood in Depressed Teens-3 (TeenThrive)

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ClinicalTrials.gov Identifier: NCT03831360
Recruitment Status : Not yet recruiting
First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
Butler Hospital
Information provided by (Responsible Party):
Brown University

Brief Summary:
Phase 3 is a randomized clinical trial of yoga vs group CBT for adolescents with depression.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Yoga Behavioral: Group CBT Not Applicable

Detailed Description:

In Phase 3, Study A, the investigators will conduct a pilot 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.

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adaptation and Pilot Study of Yoga to Reduce Depression in Adolescents
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hatha Yoga
12 weeks of hatha yoga
Behavioral: Yoga
Hatha yoga for depressed adolescents

Experimental: Group CBT
12 weeks of group CBT
Behavioral: Group CBT
Group cognitive behavioral therapy for depressed adolescents




Primary Outcome Measures :
  1. Qualitative interview [ Time Frame: post intervention (month 3) ]
    Acceptability assessed with Qualitative interview

  2. Credibility Expectancy Questionnaire (CEQ) - Credibility Subscale [ Time Frame: Week 1 ]
    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 measured on a 1-9 scale (not at all - very), Higher scores indicate greater credibility.

  3. Credibility Expectancy Questionnaire (CEQ) - Expectancy Subscale [ Time Frame: Week 1 ]
    Patient expectations assessed with the Credibility Expectancy Questionnaire (CEQ), expectancy subscale. The expectancy subscale is a 3 item subscale of the 6 item CEQ. One of the 3 items are measured on a 1-9 scale (not at all - very), 2 are on a 0-10 scale (0-100%). Higher scores indicate greater expectations.

  4. The Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: Post intervention (month 3) ]
    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. Higher scores indicate greater client satisfaction.

  5. Home practice questionnaire [ Time Frame: Post intervention (month 3) ]
    Yoga home practice assessed with a Home practice questionnaire. Duration, frequency, and type of formal and informal home yoga practice between class sessions.

  6. Systematic assessment of treatment-emergent events-general inquiry (SAFTEE) [ Time Frame: Post intervention (month 3) ]
    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.


Secondary Outcome Measures :
  1. Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR) [ Time Frame: Baseline to post intervention (month 3); Baseline to 6 months; Baseline to 9 months ]
    Change in depression symptom severity will be assessed via blind evaluator using the the QIDS. The QIDS is a 17 item measure with scores ranging from 0-30. Higher scores indicate greater depressive symptoms.



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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Please note, inclusion criteria for Phase 3 Study A, and Phase 3 Study B are identical, with the exception that, for Phase 3/ Study B, we will not require elevated depressive symptoms (a) or stable treatment (b).

  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:

Exclusion criteria for Phase 3 Study A, and Phase 3 Study B are identical.

  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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831360


Contacts
Contact: Lisa Uebelacker, PhD 401-455-6381 luebelacker@butler.org
Contact: Shirley Yen, PhD 401-455-1915 shirley_yen_phd@brown.edu

Locations
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Brown University
National Center for Complementary and Integrative Health (NCCIH)
Butler Hospital
Investigators
Principal Investigator: Lisa Uebelacker, PhD Butler Hospital
Principal Investigator: Shirley Yen, PhD Brown University

Responsible Party: Brown University
ClinicalTrials.gov Identifier: NCT03831360     History of Changes
Other Study ID Numbers: THRIVE-3
R34AT009886 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders