Positive Affect Treatment for Adolescents With Early Life Adversity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Positive affect treatment, Supportive psychotherapy (SUP).
- Who it may be relevant to
- Registry conditions: Depression. Basic parameters: 12 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Mitigating Depression Among Adversity Exposed Adolescents Using Positive Affect Therapy
Overview
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.
Interventions
- 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 aspec - Behavioral 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 measures
- 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]
Secondary outcome measures (1)
- Inflammatory gene expression [Time frame: 4 months / end of treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of California Irvine — Irvine
Identifiers
NCT: NCT06273137 · 2963