Clinical trial NCT02480257: UCSF TARA Study: Training for Awareness, Resilience and Action
Official title: University of California San Francisco (UCSF) TARA Study: Training for Awareness, Resilience and Action
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Keywords: intervention
emotion regulation
fMRI
mindfulness
yoga-based movement
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Edgewood Center for Children and Families
First posted: 2015-06-24
Enrollment: 26
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Reynolds Adolescent Depression Scale (RADS-2)
timeFrame: Change from 0 to 3 months
measure: Multidimensional Anxiety Scale for Children (MASC)
timeFrame: Change from 0 to 3 months
Secondary outcomes:
measure: Children's Depression Rating Scale, Revised (CDRS-R)
timeFrame: 0, 3, and 6mos
measure: Insomnia Severity Index (ISI)
timeFrame: 0, 3, and 6 mos
measure: Affective Reactivity Index (ARI)
timeFrame: 0, 3, and 6 mos
measure: The Avoidance and Fusion Questionnaire for Youth (AFQ-Y8)
timeFrame: 0, 3, and 6 mos
measure: Child and Adolescent Mindfulness Measure (CAMM)
timeFrame: 0, 3, and 6 mos
measure: Dot-Probe Attention Task
timeFrame: 0, 3, and 6 mos
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Osher Center for Integrative Medicine
state: California
Study officials:
affiliation: University of California, San Francisco
name: Rick M Hecht, MD
role: PRINCIPAL_INVESTIGATOR
References: