Positive Affect Treatment for Adolescents With Early Life Adversity

Depression Clinical Trial

— PAT4ELA  

Official title:

Mitigating Depression Among Adversity Exposed Adolescents Using Positive Affect Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06273137
• Other study ID #: 2963
• Status: Recruiting
• Phase: N/A
• Start date: February 3, 2024
• Est. completion date: October 16, 2026

Study information

• Verified date: February 2024
• Source: University of California, Irvine
• Contact: Kate R Kuhlman, Ph.D.
• Phone: 9498245574
• Email: krkuhl[@]uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: October 16, 2026
• Est. primary completion date: February 16, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression

Intervention

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.

Locations

Country	Name	City	State
United States	University of California Irvine	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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