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

Mitigating Depression Among Adversity Exposed Adolescents Using Positive Affect Therapy

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 this pilot, the investigators will recruit 22 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. At study enrollment, then 4-, 8, and 12-months thereafter the investigators will measure positive affect and depressive symptoms (including anhedonia). The results of this study will be used to inform whether PAT has the potential to prevent major depressive episodes among adversity-exposed youth.

Study Overview

• Status: Recruiting
• Conditions: Depression
• Intervention / Treatment: Behavioral: Positive affect treatment

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kate R Kuhlman, Ph.D.; Phone Number: 9498245574; Email: krkuhl@uci.edu

Study Locations

• United States
  • California
    • Irvine, California, United States, 92617
      • Recruiting
      • University of California Irvine
      • Contact: Kate R Kuhlman; Phone Number: 949-824-5574; Email: krkuhl@uci.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waitlist
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.	Behavioral: 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.; Other Names: PAT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive affect	Positive and negative affect Schedule (PANAS) - positive affect subscale score; scores can range from 10 to 50 with higher values indicating more positive affect.	4-months / end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
depressive symptoms - total	Reynolds Adolescent Depression Scale 2nd Edition (RADS-2) - Total Score; Scores can range from 30-120 with higher values indicating more depressive symptoms.	4 months / end of treatment
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
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
Inflammatory gene expression	Degree of expression of 19 pro-inflammatory genes as measured via genome-wide transcriptional profiling of RNA from peripheral blood mononuclear cells. Values are expressed as z-scores, and higher values indicate greater average expression of pro-inflammatory genes.	4 months / end of treatment

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Investigators: Principal Investigator: Kate R Kuhlman, UC Irvine

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2024
• Primary Completion (Estimated): February 16, 2026
• Study Completion (Estimated): October 16, 2026

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 22, 2024

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 25, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 2963

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No