What side effects are associated with this type of intervention?

Common treatments for depression, such as Cognitive Behavioral Therapy (CBT) and mindfulness-based therapies, generally have minimal physical side effects but may cause emotional discomfort as patients confront distressing thoughts and feelings. Antidepressant medications, often used alongside these therapies, can have side effects including nausea, weight gain, sexual dysfunction, insomnia, dry mouth, and increased anxiety. It's important for patients to discuss these potential side effects with their healthcare provider to tailor the treatment plan to their individual needs.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of depression, including selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, serotonin-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine, and atypical antidepressants like bupropion. These medications primarily aim to balance neurotransmitters in the brain to improve mood and reduce depressive symptoms. While these treatments do not specifically target positive affect, they are designed to alleviate overall depressive symptoms, which may indirectly enhance positive affect. Additionally, psychotherapies like Cognitive Behavioral Therapy (CBT) have been shown to be effective, often used in combination with pharmacotherapy to improve outcomes in depression treatment.

What other types of research exist?

Promising novel alternatives to PAT for treating depression in 2024 include: 1) Digital Cognitive Behavioral Therapy (CBT), which has shown efficacy in improving psychological well-being and reducing depressive symptoms through online platforms. 2) Mindfulness-Based Cognitive Therapy (MBCT), which combines mindfulness practices with cognitive therapy to prevent relapse in recurrent depression. 3) Proactive Telephone Counseling, which provides personalized support and has demonstrated improved outcomes in various mental health conditions. 4) Automated Text Messaging Interventions, which offer immediate support and motivational messages to manage depressive symptoms effectively.

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Behavioral Intervention

Positive Affect Treatment for Depression (PAT4ELA Trial)

N/A

Recruiting

Led By Kate R Kuhlman

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 12-16

Be younger than 18 years old

Must not have

Current or past history of manic or psychotic symptoms

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months / end of treatment

Awards & highlights

Summary

This trial tests whether Positive Affect Training (PAT) can help adolescents who have faced early life adversities feel more positive emotions and reduce their risk of depression. The study involves 22 adolescents and measures their mood over several months to see if PAT is effective.

Who is the study for?

This trial is for adolescents who have faced two or more types of childhood adversity but do not currently suffer from major depressive disorder. It aims to help those at risk for depression due to early life challenges.

What is being tested?

The study tests Positive Affect Treatment (PAT) on these youths, comparing a group receiving PAT with a waitlist control group. The goal is to see if PAT can boost positive feelings and reduce symptoms of depression over time.

What are the potential side effects?

Since the intervention involves psychological treatment rather than medication, traditional physical side effects are not expected. Emotional discomfort during therapy sessions could occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 16 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have experienced manic or psychotic symptoms in the past or currently.

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I am currently taking medication for depression or to treat asthma/allergies.

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I have a bleeding disorder like hemophilia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4-months / end of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4-months / end of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-months / end of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Positive affect

Secondary study objectives

Inflammatory gene expression

Systemic inflammation - C-reactive protein (CRP)

depressive symptoms - anhedonia subscale

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Positive affect treatmentExperimental Treatment1 Intervention

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.

Group II: WaitlistActive Control1 Intervention

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for depression include pharmacological and psychotherapeutic approaches. Antidepressants like SSRIs, SNRIs, and tricyclic antidepressants work by increasing neurotransmitter levels in the brain, which helps improve mood and reduce depressive symptoms. Psychotherapies such as Cognitive Behavioral Therapy (CBT) and Positive Affect Training (PAT) focus on changing negative thought patterns and behaviors, and increasing positive emotions and coping strategies. These treatments are essential as they address both the chemical imbalances and cognitive distortions that contribute to depression, offering a more holistic approach to managing the condition.

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Who is running the clinical trial?

University of California, IrvineLead Sponsor

559 Previous Clinical Trials

1,929,986 Total Patients Enrolled

8 Trials studying Depression

6,912 Patients Enrolled for Depression

Kate R KuhlmanPrincipal InvestigatorUC Irvine

~15 spots leftby Feb 2026

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