Clinical trial NCT06273137: Positive Affect Treatment for Adolescents with Early Life Adversity
Official title: Mitigating Depression Among Adversity Exposed Adolescents Using Positive Affect Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomized to either receive PAT or one of two control conditions (waitlist, supportive psychotherapy) upon enrollment.
Primary purpose: PREVENTION

Brief summary: Youth exposed to early life adversity (ELA) are known to be at greater risk for depression and suicidality and account for almost half of the youth suffering from psychiatric diseases today. Youth exposed to ELA consistently report symptoms of anhedonia as well as dysregulated positive affect. The present project will test the efficacy of PAT in a sample of ELA-exposed adolescents in order to determine whether PAT increases positive affect, and subsequently symptoms of depression. For the initial pilot phase of the investigation, the investigators will recruit up to 30 adolescents exposed to two or more childhood adversities (ACEs) who do not currently have major depressive disorder, and randomize them (1:1) to either participate in PAT or a waitlist control condition. For the second phase of the investigation, the investigators will recruit up to 300 adolescents exposed to two or more childhood adversities (ACEs) who do not currently have major depressive disorder, and randomize them (1:1) to either participate in PAT or supportive psychotherapy. For both phases, at study enrollment, then 4-, 8, and 12-months thereafter the investigators will measure positive affect and depressive symptoms (including anhedonia and reward sensitivity). The results of this study will be used to inform whether PAT has the potential to prevent major depressive episodes among adversity-exposed youth.


Eligibility criteria: Inclusion Criteria:

* aged 12-16
* exposed to 2 or more adverse childhood experiences (ACEs)

Exclusion Criteria:

* currently taking an antidepressant or any medications known to influence immune functioning on a daily basis (e.g., steroidal medications to treat asthma or allergies)
* current or past history of manic or psychotic symptoms
* parent-reported diagnosis of intellectual disability or autism spectrum disorder
* chronic medical conditions (e.g., cancer, rheumatoid arthritis, diabetes, multiple sclerosis),
* bleeding disorders such as hemophilia

Primary outcomes:
measure: depressive symptoms - anhedonia subscale
timeFrame: 4 months / end of treatment
measure: reward sensitivity
timeFrame: 4 months / end of treatment
measure: Systemic inflammation - C-reactive protein (CRP)
timeFrame: 4 months / end of treatment
Secondary outcomes:
measure: Inflammatory gene expression
timeFrame: 4 months / end of treatment
Other outcomes:
measure: Positive affect
timeFrame: 4-months / end of treatment
measure: depressive symptoms - total
timeFrame: 4 months / end of treatment
Locations:
city: Irvine
country: United States
facility: University of California Irvine
state: California
Study officials:
affiliation: UC Irvine
name: Kate R Kuhlman
role: PRINCIPAL_INVESTIGATOR
References: