Positive Affect Treatment for Adolescents with Early Life Adversity (PAT4ELA)

University of California Irvine (UCI)

Status: Enrolling

Conditions: Depression

Treatments: Behavioral: Supportive psychotherapy (SUP); Behavioral: Positive affect treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06273137

2963

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 12 to 16 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Positive affect treatment

Experimental group

Description:

PAT is a 15-week cognitive-behavioral therapy that focuses on increasing reward motivation and sensitivity at the neural, behavioral, and affective levels of analysis. These observed effects occur through PAT's effects on reward sensitivity and positive affect. Participants will be assigned to a therapist with training in cognitive-behavioral therapy who will meet with them weekly via telehealth.

Treatment:

Behavioral: Positive affect treatment

Waitlist

No Intervention group

Supportive Psychotherapy (SUP)

Active Comparator group

Description:

Participants randomized to SUP will receive 15 weeks of SUP from a doctoral student in clinical psychology. SUP is a flexibly-delivered, manualized evidence-based treatment that focuses on reinforcing a patient's existing coping strategies while fostering a positive therapeutic relationship. Supportive psychotherapy provides a time, attention, and social support control that is similar to a placebo but likely to be perceived as relevant to this population.

Treatment:

Behavioral: Supportive psychotherapy (SUP)