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Adolescent Attention to Emotion Study

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ClinicalTrials.gov Identifier: NCT04105868
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : December 10, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Mary Woody, University of Pittsburgh

Brief Summary:
Rates of depression increase rapidly during adolescence, especially for girls, and, thus, research is needed to spur the development of novel interventions to prevent adolescent depression. This project seeks to determine if a novel visuocortical probe of affect-biased attention (i.e., steady-state visual evoked potentials derived from EEG) can 1) be used to prospectively predict depression using a multi-wave repeated measures design and 2) modify affect-biased attention and buffer subsequent mood reactivity using real time neurofeedback. This work could ultimately lead to improved identification of adolescents who are at high risk for depression and directly inform the development of mechanistic treatment targets to be used in personalized intervention prescriptions for high-risk youth.

Condition or disease Intervention/treatment Phase
Depression Other: Neurofeedback Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Visuocortical Dynamics of Affect-Biased Attention in the Development of Adolescent Depression
Actual Study Start Date : October 16, 2019
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Neurofeedback
Participants will receive feedback about their attention to negative distractors during each trial using activity from their brain waves, which will help them reduce their attention to distractors.
Other: Neurofeedback
Participants will receive feedback during a computerized task that is based on their own visuocortical activity evoked by attention to negative distractors and task-relevant stimuli on the computer screen.




Primary Outcome Measures :
  1. Change from baseline in affect-biased attention subsequently following neurofeedback (~1 hour) [ Time Frame: Baseline and following neurofeedback (~1 hour) ]
    To measure affect-biased attention, steady-state visual evoked potentials (SSVEPs) will be derived from EEG and will be used to index the amount of stimulus-driven attention to the negative distractors relative to goal-directed attention toward task-relevant stimuli. Larger SSVEPs indicate more attention to that stimulus. Affect-biased attention will be measured both before and after the real time SSVEP neurofeedback training to assess changes in affect-biased attention pre- to post-intervention.


Secondary Outcome Measures :
  1. Change from baseline in sadness after laboratory stressor, which follows neurofeedback [ Time Frame: Baseline and following laboratory stressor (~30 minutes) ]
    Participants will complete a laboratory stressor following real time SSVEP neurofeedback training to assess how well it buffers sadness reactivity. To assess sadness reactivity, girls will report state sadness before and after the stressor using Visual Analog Scales. Participants will mark how they are feeling between neutral to very sad on a scale measuring 100 millimeters, with higher scores indicating greater state sadness.

  2. Change from baseline in anxiety after laboratory stressor, which follows neurofeedback [ Time Frame: Baseline and following laboratory stressor (~30 minutes) ]
    Participants will complete a laboratory stressor following real time SSVEP neurofeedback training to assess how well it buffers anxiety reactivity. To assess anxiety reactivity, girls will report state anxiety before and after the stressor using Visual Analog Scales.Participants will mark how they are feeling between neutral to very anxious on a scale measuring 100 millimeters, with higher scores indicating greater state anxiety.



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Ages Eligible for Study:   13 Years to 15 Years   (Child)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants will include 90 female adolescents ages 13 years 0 months through 15 years 11 months at study entry.

Exclusion Criteria:

  1. Lifetime history of any DSM 5 depressive disorder
  2. Lifetime history of taking antidepressants (e.g., SSRIs)
  3. Lifetime history of a DSM 5 psychotic, bipolar, or autistic spectrum disorder.
  4. Presence of EEG contraindications (e.g., personal lifetime history of seizures or family history of hereditary epilepsy).
  5. Being pre-pubertal
  6. Lifetime history of a neurological or serious medical condition.
  7. Lifetime history of head injury or congenital neurological anomalies (based on parent report).
  8. IQ less than 80, as assessed using the Wechsler Abbreviated Scale of Intelligence (WASI).
  9. Uncorrected visual disturbance
  10. Being acutely suicidal or at risk for harm to self or others.

Information from the National Library of Medicine

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): NCT04105868


Contacts
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Contact: Mary Woody, PhD 412-648-6560 woodyml@upmc.edu
Contact: Anna Wears, BS 412-648-6541 wearsa@upmc.edu

Locations
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United States, Pennsylvania
Western Psychiatric Institute and Clinic Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Mary Woody, Phd    412-648-6560      
Sponsors and Collaborators
University of Pittsburgh
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Mary Woody, PhD University of Pittsburgh

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Responsible Party: Mary Woody, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04105868    
Other Study ID Numbers: STUDY19010063
K23MH119225 ( U.S. NIH Grant/Contract )
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will comply with all NIMH guidelines regarding data repository/sharing.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders