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UCSF TARA Study: Training for Awareness, Resilience and Action

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ClinicalTrials.gov Identifier: NCT02480257
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
Edgewood Center for Children and Families
Information provided by (Responsible Party):
Rick Hecht, University of California, San Francisco

Brief Summary:
The investigators aim to refine and pilot test an innovative group treatment model for adolescent depression and anxiety, Training for Awareness, Resilience and Action (TARA) in a sample of 14-18 year olds with depressive or anxious symptoms.

Condition or disease Intervention/treatment Phase
Depression Anxiety Behavioral: TARA Not Applicable

Detailed Description:
The investigators aim to refine and pilot test an innovative group treatment model for adolescent depression and anxiety, Training for Awareness, Resilience and Action (TARA). TARA is based on our current understanding of the neuroscience of adolescent depression and anxiety. It employs specific approaches drawn from mindfulness practices and yoga to promote physiological regulation and attention modulation, emotion regulation, and cognitive control. The investigators will perform three initial (non-randomized) beta tests with 6-12 participants each to refine our intervention manual. The investigators will enroll up to 30 participants total, aged 14-18 with depression and/or anxiety symptoms, to receive the TARA intervention. The investigators hypothesize that TARA will be feasible in terms of recruitment, retention, adherence, and participant receptivity to the intervention as gauged through feedback surveys and a focus group. The primary outcomes are depression symptoms assessed with the Reynolds Adolescent Depression Scale (RADS-2) and anxiety symptoms assessed with the Multidimensional Anxiety Scale for Children (MASC). Secondary outcomes include self-reported emotion regulation and attention/awareness. The investigators hypothesize that participants will show improvements in these measures. In a small subset of participants, the investigators will also test the feasibility of using functional MRI (fMRI) before and after the intervention to measure the underlying neurobiological effects of TARA. The aim is to develop a protocol for possible future use in a larger study to examine effects of the intervention on patterns of amygdala activation linked with adolescent depression.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: University of California San Francisco (UCSF) TARA Study: Training for Awareness, Resilience and Action
Study Start Date : January 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: TARA Intervention group
TARA is comprised of 12 weekly classes delivered in a group format by two trained facilitators with approximately 8-15 participants. The 90 minute sessions are designed to promote skills for autonomic regulation, attention modulation, emotion regulation and cognitive control.
Behavioral: TARA
The intervention consists of four 3-week modules: 1. Autonomic regulation: Learning and practicing the ability to create a calm and safe inner state through breathing exercises and movement/physical activity. 2. Interoceptive awareness: Attention training, targeting external stimuli then sensory stimuli using short body scan exercises and guided meditations. 3.Emotion regulation: Recognizing, labeling, externalizing, and befriending emotions. 4. Metacognition, core-values, and committed action: Understanding social triggers to negative emotions and experiential avoidance strategies and their impact on obtaining desired life-goals. Home practice of TARA skills is encouraged, with breathing instructions and short, guided meditations provided via audio tracks.




Primary Outcome Measures :
  1. Reynolds Adolescent Depression Scale (RADS-2) [ Time Frame: Change from 0 to 3 months ]
    Self report, 30-item measure of 4 dimensions of depression: Dysphoric Mood, Anhedonia/Negative Affect, Negative Self-Evaluation, and Somatic Complaints

  2. Multidimensional Anxiety Scale for Children (MASC) [ Time Frame: Change from 0 to 3 months ]
    Self report measure of anxiety,with 39 items distributed across four major factors, three of which can be parsed into two subfactors each. Main and subfactors include (1) physical symptoms (tense/restless and somatic/autonomic), (2) social anxiety (humiliation/rejection and public performance fears), (3) harm avoidance (perfectionism and anxious coping), and (4) separation anxiety.


Secondary Outcome Measures :
  1. Children's Depression Rating Scale, Revised (CDRS-R) [ Time Frame: 0, 3, and 6mos ]
    Standardized rating scale depression based on semi-structured interview. Seventeen symptom areas are assessed during the interview with a 5 or 7 point rating scale for each of the 17 domains. Each item is rated on a scale of 1 to 7, with 1 being least severe (no difficulties) to 7 indicating severe clinical difficulties. Domains assessed align with Diagnostic and Statistical Manual-IV (DSM-IV) criteria for childhood depression.

  2. Insomnia Severity Index (ISI) [ Time Frame: 0, 3, and 6 mos ]
    Self-report, 7-item assessment scale for sleeping problems.

  3. Affective Reactivity Index (ARI) [ Time Frame: 0, 3, and 6 mos ]
    Self-report, 6-item measure of irritability in children and teenagers.

  4. The Avoidance and Fusion Questionnaire for Youth (AFQ-Y8) [ Time Frame: 0, 3, and 6 mos ]
    8-item self-report measure of psychological inflexibility fostered by: (1) Cognitive fusion (2) Experiential avoidance (3) Inaction or behavioral ineffectiveness in the presence of unwanted internal experiences.

  5. Child and Adolescent Mindfulness Measure (CAMM) [ Time Frame: 0, 3, and 6 mos ]
    10-item self-report measure of acceptance and mindfulness for youth.

  6. Dot-Probe Attention Task [ Time Frame: 0, 3, and 6 mos ]
    Motivated attention task administered via computer to capture attentional bias toward emotional cues.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 14-18 years old, and not yet graduated from high school.
  • Post-pubertal (Tanner Stage , stage 3+).
  • CDRS-R score≥35 or MASC score≥56.
  • Currently under the care of a physician or mental health provider for depression and/or anxiety.

Exclusion Criteria:

  • Current comorbidity of psychosis, severe anorexia nervosa, PTSD, severe self-mutilation, severe suicidal ideation or attempt in past 3 mos.
  • Comorbidity (lifetime) of bipolar disorder, low-functioning autism spectrum disorder, intellectual disability (estimated intelligence quotient < 80).
  • A substance abuse, mental health, or medical condition that, in the opinion of investigators, will make it difficult for the potential participant to participate in the group intervention.
  • Non English speaker.
  • Current mindfulness training (e.g. Mindfulness Based Stress Reduction or Mindfulness Based Cognitive Therapy or Dialectical Behavior Therapy) and/or practice with a typically sitting meditation or yoga of 20 or more minutes two or more times per week for the past two months.
  • Unable to attend study assessments and classes in San Francisco as scheduled.
  • Special exclusion criteria will be applied for fMRI participation for safety reasons (pregnancy, claustrophobia, metallic implants); left-handedness; and for task performance (colorblindness or less than 20/40 correctable vision); not willing to abstain from alcohol and/or drugs for 2 weeks prior to the MRI . These participants can be included in the study but will be excluded from participation in fMRI.

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): NCT02480257


Locations
United States, California
UCSF Osher Center for Integrative Medicine
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Edgewood Center for Children and Families
Investigators
Principal Investigator: Rick M Hecht, MD University of California, San Francisco

Responsible Party: Rick Hecht, Professor of Medicine, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02480257     History of Changes
Other Study ID Numbers: 13-12380
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017

Keywords provided by Rick Hecht, University of California, San Francisco:
intervention
emotion regulation
fMRI
mindfulness
yoga-based movement