DepressionNCT02480257
UCSF TARA Study: Training for Awareness, Resilience and Action
A study testing TARA in people with Depression and Anxiety, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- TARA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Osher Center for Integrative Medicine
San Francisco, California, 94115
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression, Anxiety
- Being tested
- TARA
- Keywords
- intervention, emotion regulation, fMRI, mindfulness, yoga-based movement
- Medical subject headings
- Depression, Anxiety Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TARABehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: TARA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Change from 0 to 3 months
Secondary outcomes (6)
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.
Measured: 0, 3, and 6mos
Insomnia Severity Index (ISI)
Self-report, 7-item assessment scale for sleeping problems.
Measured: 0, 3, and 6 mos
Affective Reactivity Index (ARI)
Self-report, 6-item measure of irritability in children and teenagers.
Measured: 0, 3, and 6 mos
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.
Measured: 0, 3, and 6 mos
Child and Adolescent Mindfulness Measure (CAMM)
10-item self-report measure of acceptance and mindfulness for youth.
Measured: 0, 3, and 6 mos
Dot-Probe Attention Task
Motivated attention task administered via computer to capture attentional bias toward emotional cues.
Measured: 0, 3, and 6 mos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Edgewood Center for Children and Families
- Responsible party
- Sponsor
- Investigators
- Rick M Hecht, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480257
- Sponsor's protocol ID
- 13-12380
- Status last verified
- Mar 2022
- First submitted
- 10 Jun 2015
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of California San Francisco (UCSF) TARA Study: Training for Awareness, Resilience and Action
- ClinicalTrials.gov ID
- NCT02480257
- Acronym / sponsor ID
- 13-12380
- Conditions
- Depression, Anxiety
- Keywords
- intervention, emotion regulation, fMRI, mindfulness, yoga-based movement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Edgewood Center for Children and Families
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TARA Intervention group | Experimental | Behavioral: TARATARA 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. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TARAThe 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. | Behavioural | TARA Intervention group |
Primary outcome
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.
6 secondary outcomes
Children's Depression Rating Scale, Revised (CDRS-R)
Time frame: 0, 3, and 6mos
Insomnia Severity Index (ISI)
Time frame: 0, 3, and 6 mos
Affective Reactivity Index (ARI)
Time frame: 0, 3, and 6 mos
The Avoidance and Fusion Questionnaire for Youth (AFQ-Y8)
Time frame: 0, 3, and 6 mos
Child and Adolescent Mindfulness Measure (CAMM)
Time frame: 0, 3, and 6 mos
Dot-Probe Attention Task
Time frame: 0, 3, and 6 mos
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rick M Hecht, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TARA in people with Depression and Anxiety, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reynolds Adolescent Depression Scale (RADS-2) (time frame: Change from 0 to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.