Positive Affect Treatment for Adolescents With Early Life Adversity

NCT06273137 | Recruiting

• 1 other identifier: 2963
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• depressive symptoms - anhedonia subscale

  Reynolds Adolescent Depression Scale 2nd Edition - anhedonia subscale score; Scores can range from 7-28 with higher values indicating more severe anhedonia.

  4 months / end of treatment

• reward sensitivity

  Reward motivation will be assessed behaviorally with the Effort Expenditures for Reward Task (EEfRT). The EEfRT assesses reward sensitivity by compelling participants to choose to engage in high and low effort motor tasks for varying potential monetary gains and computes reward sensitivity as the difference in propensity to choose hard choice trials at increasing trial values.

  4 months / end of treatment

• Systemic inflammation - C-reactive protein (CRP)

  C-reactive protein concentrations measured in saliva; assay detection range is approximately 25 pg/mL - 1600 pg/mL with higher values indicating the presence of more systemic inflammation.

  4 months / end of treatment

• 8. Self-reported reward sensitivity

  Self-reported reward sensitivity will be assessed using the 21-item Positive Valence System Scale (PVSS-21) which will be assessed at study enrollment, and then 4-, 8-, and 12-months after study enrollment. For each item, responses can range from 1-8, and the questionnaire is scored using a sum. Total scores can range from 21 - 189 and lower scores reflect a worse outcome.

  4 months / end of treatment

Secondary Outcomes (1)

• Inflammatory gene expression

  4 months / end of treatment

Other Outcomes (2)

• Positive affect

  4-months / end of treatment

• depressive symptoms - total

  4 months / end of treatment

Study Arms (3)

Positive affect treatment

EXPERIMENTAL

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.

Behavioral: Positive affect treatment

Waitlist

NO INTERVENTION

Supportive Psychotherapy (SUP)

ACTIVE COMPARATOR

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.

Behavioral: Supportive psychotherapy (SUP)

Interventions

Supportive psychotherapy (SUP) BEHAVIORAL

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.

Supportive Psychotherapy (SUP)

Positive affect treatment BEHAVIORAL

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.

Also known as: PAT

Positive affect treatment

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California Irvine

Irvine, California, 92617, United States

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Kate R Kuhlman

  UC Irvine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kate R Kuhlman, Ph.D.

CONTACT

9498245574; krkuhl@uci.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomized to either receive PAT or one of two control conditions (waitlist, supportive psychotherapy) upon enrollment.

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: February 3, 2024
• Primary Completion (Estimated): October 31, 2030
• Study Completion (Estimated): October 31, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)