UCSF TARA Study: Training for Awareness, Resilience and Action

NCT02480257 | Completed

• 1 other identifier: 13-12380
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety

Keywords

intervention; emotion regulation; fMRI; mindfulness; yoga-based movement

Outcome Measures

Primary Outcomes (2)

• Reynolds Adolescent Depression Scale (RADS-2)

  Self report, 30-item measure of 4 dimensions of depression: Dysphoric Mood, Anhedonia/Negative Affect, Negative Self-Evaluation, and Somatic Complaints

  Change from 0 to 3 months

• Multidimensional Anxiety Scale for Children (MASC)

  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.

  Change from 0 to 3 months

Secondary Outcomes (6)

• Children's Depression Rating Scale, Revised (CDRS-R)

  0, 3, and 6mos

• Insomnia Severity Index (ISI)

  0, 3, and 6 mos

• Affective Reactivity Index (ARI)

  0, 3, and 6 mos

• The Avoidance and Fusion Questionnaire for Youth (AFQ-Y8)

  0, 3, and 6 mos

• Child and Adolescent Mindfulness Measure (CAMM)

  0, 3, and 6 mos

Study Arms (1)

TARA Intervention group

EXPERIMENTAL

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

Interventions

TARA BEHAVIORAL

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.

TARA Intervention group

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Edgewood Center for Children and Families: collaborator

Study Sites (1)

UCSF Osher Center for Integrative Medicine

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Emotional Regulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Self-Control; Social Behavior

Study Officials

• Rick M Hecht, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 24, 2015
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 22, 2022

Record last verified: 2022-03

Locations

US (1)