- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02480257
UCSF TARA Study: Training for Awareness, Resilience and Action
March 7, 2022 updated by: University of California, San Francisco
University of California San Francisco (UCSF) TARA Study: Training for Awareness, Resilience and Action
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.
Study Overview
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
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Francisco, California, United States, 94115
- UCSF Osher Center for Integrative Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reynolds Adolescent Depression Scale (RADS-2)
Time Frame: Change from 0 to 3 months
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Self report, 30-item measure of 4 dimensions of depression: Dysphoric Mood, Anhedonia/Negative Affect, Negative Self-Evaluation, and Somatic Complaints
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Change from 0 to 3 months
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Multidimensional Anxiety Scale for Children (MASC)
Time Frame: Change from 0 to 3 months
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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.
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Change from 0 to 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Children's Depression Rating Scale, Revised (CDRS-R)
Time Frame: 0, 3, and 6mos
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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.
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0, 3, and 6mos
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Insomnia Severity Index (ISI)
Time Frame: 0, 3, and 6 mos
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Self-report, 7-item assessment scale for sleeping problems.
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0, 3, and 6 mos
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Affective Reactivity Index (ARI)
Time Frame: 0, 3, and 6 mos
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Self-report, 6-item measure of irritability in children and teenagers.
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0, 3, and 6 mos
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The Avoidance and Fusion Questionnaire for Youth (AFQ-Y8)
Time Frame: 0, 3, and 6 mos
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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.
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0, 3, and 6 mos
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Child and Adolescent Mindfulness Measure (CAMM)
Time Frame: 0, 3, and 6 mos
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10-item self-report measure of acceptance and mindfulness for youth.
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0, 3, and 6 mos
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Dot-Probe Attention Task
Time Frame: 0, 3, and 6 mos
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Motivated attention task administered via computer to capture attentional bias toward emotional cues.
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0, 3, and 6 mos
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Rick M Hecht, MD, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (ACTUAL)
December 1, 2015
Study Completion (ACTUAL)
December 1, 2015
Study Registration Dates
First Submitted
June 10, 2015
First Submitted That Met QC Criteria
June 19, 2015
First Posted (ESTIMATE)
June 24, 2015
Study Record Updates
Last Update Posted (ACTUAL)
March 22, 2022
Last Update Submitted That Met QC Criteria
March 7, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-12380
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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