Recruiting

Positive Affect Treatment

Sponsor:

UCLA

Code:

NCT06273137

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 12 - 16

Healthy Volunteers: Accepted

Interventions

Positive affect treatment

Supportive psychotherapy (SUP)

Study Details

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.

Conditions

Depression

Study ID

NCT06273137

Start date

Feb 3, 2024

Status verified date

Apr, 2026

Completion date

Oct 31, 2030

Anticipated

Primary completion date

Oct 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 16

Healthy Volunteers: Accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Positive affect treatment

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.

no intervention: Waitlist

active comparator: Supportive Psychotherapy (SUP)

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.

Interventions

Positive affect treatment

PAT includes 15 weekly, 1-hour sessions. The treatment is composed of three modules targeting behaviors (Sessions 1-7), cognitions (Sessions 8 -10), and compassion (Sessions 11-14), with skills being reinforced in a cumulative manner in subsequent sessions. The final session in the original treatment (Session 15) addressed relapse prevention, which will be adapted to focus on further reinforcing and generalizing learned skills. The treatment includes guided activities that target different aspects of positive affectivity such as reward approach-motivation, reward learning, and reward attainment.

Supportive psychotherapy (SUP)

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.

Primary outcome measure

  • depressive symptoms - anhedonia subscale [ Time Frame: 4 months / end of treatment ]
  • reward sensitivity [ Time Frame: 4 months / end of treatment ]
  • Systemic inflammation - C-reactive protein (CRP) [ Time Frame: 4 months / end of treatment ]
  • 8. Self-reported reward sensitivity [ Time Frame: 4 months / end of treatment ]

Central Contacts and Locations

Central contacts

Kate R Kuhlman, Ph.D.

9498245574krkuhl@uci.edu

Locations

University of California Irvine

Recruiting

Irvine, California, United States, 92617

Contacts

Kate R Kuhlman

9498245574krkuhl@uci.edu

More Information

Sponsor

University of California, Irvine

Last update posted

May 6, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-05-06.