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
|Condition or disease||Intervention/treatment||Phase|
|Depression Anxiety||Behavioral: TARA||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- 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
- 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.
- 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.
- Insomnia Severity Index (ISI) [ Time Frame: 0, 3, and 6 mos ]Self-report, 7-item assessment scale for sleeping problems.
- Affective Reactivity Index (ARI) [ Time Frame: 0, 3, and 6 mos ]Self-report, 6-item measure of irritability in children and teenagers.
- 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.
- Child and Adolescent Mindfulness Measure (CAMM) [ Time Frame: 0, 3, and 6 mos ]10-item self-report measure of acceptance and mindfulness for youth.
- Dot-Probe Attention Task [ Time Frame: 0, 3, and 6 mos ]Motivated attention task administered via computer to capture attentional bias toward emotional cues.
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
|United States, California|
|UCSF Osher Center for Integrative Medicine|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Rick M Hecht, MD||University of California, San Francisco|