Clinical trial NCT04105868: Adolescent Attention to Emotion Study
Official title: Visuocortical Dynamics of Affect-Biased Attention in the Development of Adolescent Depression
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-09-26
Enrollment: 70
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: Change from baseline in affect-biased attention subsequently following neurofeedback (~1 hour)
timeFrame: Baseline and following neurofeedback (~1 hour)
Secondary outcomes:
measure: Change from baseline in sadness after laboratory stressor, which follows neurofeedback
timeFrame: Baseline and following laboratory stressor (~30 minutes)
measure: Change from baseline in anxiety after laboratory stressor, which follows neurofeedback
timeFrame: Baseline and following laboratory stressor (~30 minutes)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute and Clinic
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Mary Woody, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huang X, Mak J, Wears A, Price RB, Akcakaya M, Ostadabbas S, Woody ML. Using Neurofeedback from Steady-State Visual Evoked Potentials to Target Affect-Biased Attention in Augmented Reality. Annu Int Conf IEEE Eng Med Biol Soc. 2022 Jul;2022:2314-2318. doi: 10.1109/EMBC48229.2022.9871982.