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UCSF TARA Study: Training for Awareness, Resilience and Action

Primary Purpose

Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TARA
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring intervention, emotion regulation, fMRI, mindfulness, yoga-based movement

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCSF Osher Center for Integrative Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TARA Intervention group

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Children's Depression Rating Scale, Revised (CDRS-R)
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)
Self-report, 7-item assessment scale for sleeping problems.
Affective Reactivity Index (ARI)
Self-report, 6-item measure of irritability in children and teenagers.
The Avoidance and Fusion Questionnaire for Youth (AFQ-Y8)
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)
10-item self-report measure of acceptance and mindfulness for youth.
Dot-Probe Attention Task
Motivated attention task administered via computer to capture attentional bias toward emotional cues.

Full Information

First Posted
June 10, 2015
Last Updated
March 7, 2022
Sponsor
University of California, San Francisco
Collaborators
Edgewood Center for Children and Families
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1. Study Identification

Unique Protocol Identification Number
NCT02480257
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Edgewood Center for Children and Families

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
intervention, emotion regulation, fMRI, mindfulness, yoga-based movement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TARA Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TARA
Intervention Description
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 Measure Information:
Title
Reynolds Adolescent Depression Scale (RADS-2)
Description
Self report, 30-item measure of 4 dimensions of depression: Dysphoric Mood, Anhedonia/Negative Affect, Negative Self-Evaluation, and Somatic Complaints
Time Frame
Change from 0 to 3 months
Title
Multidimensional Anxiety Scale for Children (MASC)
Description
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.
Time Frame
Change from 0 to 3 months
Secondary Outcome Measure Information:
Title
Children's Depression Rating Scale, Revised (CDRS-R)
Description
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.
Time Frame
0, 3, and 6mos
Title
Insomnia Severity Index (ISI)
Description
Self-report, 7-item assessment scale for sleeping problems.
Time Frame
0, 3, and 6 mos
Title
Affective Reactivity Index (ARI)
Description
Self-report, 6-item measure of irritability in children and teenagers.
Time Frame
0, 3, and 6 mos
Title
The Avoidance and Fusion Questionnaire for Youth (AFQ-Y8)
Description
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.
Time Frame
0, 3, and 6 mos
Title
Child and Adolescent Mindfulness Measure (CAMM)
Description
10-item self-report measure of acceptance and mindfulness for youth.
Time Frame
0, 3, and 6 mos
Title
Dot-Probe Attention Task
Description
Motivated attention task administered via computer to capture attentional bias toward emotional cues.
Time Frame
0, 3, and 6 mos

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rick M Hecht, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Osher Center for Integrative Medicine
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

UCSF TARA Study: Training for Awareness, Resilience and Action

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