What side effects are associated with this type of intervention?

Common treatments for emotional regulation, such as cognitive-behavioral therapy (CBT) and dialectical behavior therapy (DBT), generally have minimal physical side effects but can sometimes lead to emotional discomfort as individuals confront and process difficult emotions. Patients may experience temporary increases in anxiety or distress, particularly during the initial stages of therapy. Additionally, the time commitment and emotional effort required for these therapies can be challenging for some individuals. Overall, these treatments are considered safe and effective for improving emotional regulation.

What prior FDA approvals exist?

FDA-approved treatments for conditions involving emotional regulation include selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine and sertraline, which are commonly used for depression and anxiety disorders. Cognitive-behavioral therapy (CBT) is also a widely recognized and effective treatment for these conditions. While specific FDA approvals for emotion regulation skills training are not mentioned, these treatments are relevant as they address underlying emotional regulation issues.

What other types of research exist?

Promising novel alternatives to Emotion Regulation Skills Training for emotional regulation patients in 2024 include: 1) Mindfulness-Based Cognitive Therapy (MBCT), which integrates mindfulness practices with cognitive therapy techniques to improve emotional regulation and reduce negative emotions. 2) Digital and online interventions, such as app-based cognitive-behavioral therapy (CBT) programs, which offer accessible and scalable options for emotional regulation. 3) Biofeedback and neurofeedback therapies, which use real-time monitoring of physiological signals to help patients gain control over their emotional responses. 4) Acceptance and Commitment Therapy (ACT), which focuses on accepting negative emotions and committing to personal values to enhance emotional well-being.

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Emotion Regulation Strategies for Emotional Regulation Issues

N/A

Recruiting

Led By Matthew W Southward, Ph.D.

Research Sponsored by Matthew Southward

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up once every 2 weeks for 6 weeks (4 times total)

Awards & highlights

Summary

This trial tests if personalized or standardized emotion regulation helps reduce negative emotion intensity, with the hope of developing evidence-based, personalized interventions.

Who is the study for?

This trial is for individuals with conditions like PTSD, OCD, depression, eating disorders, and anxiety who struggle with regulating their emotions. Participants must be proficient in English and have access to a smartphone. It's not suitable for those needing more than outpatient care.Check my eligibility

What is being tested?

The study tests whether personalized or standardized emotion regulation skills can reduce negative emotions daily. It will also try matching participants to the best skill training based on initial data to see if this approach is effective and practical.See study design

What are the potential side effects?

Since the interventions involve psychological techniques such as 'Checking the Facts', 'Opposite to Emotion Action', and mindfulness exercises, side effects may include emotional discomfort or increased self-awareness during the process.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ once every 2 weeks for 6 weeks (4 times total)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~once every 2 weeks for 6 weeks (4 times total)

This trial's timeline: 3 weeks for screening, Varies for treatment, and once every 2 weeks for 6 weeks (4 times total) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in Positive and Negative Affect Schedule-Short Form

Secondary outcome measures

Changes in Breath-Counting Task

Changes in Five-Factor Model Score Sheet

Changes in Hamilton Anxiety Rating Scale

+4 more

Trial Design

2Treatment groups

Active Control

Group I: Personalized ConditionActive Control3 Interventions

Participants will learn one of three emotion regulation skills (i.e., cognitive restructuring, opposite to emotion action, mindfulness) that is their personal strength, based on pre-Baseline emotion regulation capacities. They will watch an interactive video, created for the current study, in which they are taught the skill that is their personal strength. They will also be asked to complete a survey during the video in which they will input their own examples to practice the skill and to ensure attention to and comprehension of the material.

Group II: Standardized ConditionActive Control3 Interventions

Participants will learn all three ER skills: cognitive restructuring, opposite to emotion action, and mindfulness. Participants will be asked to watch three interactive videos that cover each skill to provide an analogue to clinical practice in which clinicians must choose whether to provide greater breadth or depth of skill coverage. These videos will be presented in a randomized order and will include the same surveys for attention and comprehension used in the Personalized Condition.

Do I qualify?Apply below to find out

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

The most common treatments for emotional regulation include cognitive-behavioral therapy (CBT) and dialectical behavior therapy (DBT). CBT focuses on identifying and changing negative thought patterns and behaviors, thereby improving emotional responses. DBT, a variation of CBT, emphasizes mindfulness, distress tolerance, and emotional regulation skills to manage intense emotions and reduce self-destructive behaviors. Understanding these mechanisms is crucial for patients as it helps them recognize how these therapies can alter their emotional responses and improve their overall emotional functioning. Personalized approaches, as studied in the trial, may further enhance these benefits by tailoring techniques to individual needs, potentially leading to more effective and sustainable emotional regulation.

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Who is running the clinical trial?

Matthew SouthwardLead Sponsor

National Institute of Mental Health (NIMH)NIH

2,820 Previous Clinical Trials

2,692,429 Total Patients Enrolled

1 Trials studying Emotional Regulation

838 Patients Enrolled for Emotional Regulation

Matthew W Southward, Ph.D.Principal InvestigatorUniversity of Kentucky

Media Library

Checking the Facts Clinical Trial Eligibility Overview. Trial Name: NCT05651295 — N/A

Emotional Regulation Research Study Groups: Personalized Condition, Standardized Condition

Emotional Regulation Clinical Trial 2023: Checking the Facts Highlights & Side Effects. Trial Name: NCT05651295 — N/A

Checking the Facts 2023 Treatment Timeline for Medical Study. Trial Name: NCT05651295 — N/A

Emotional Regulation Patient Testimony for trial: Trial Name: NCT05651295 — N/A

~246 spots leftby Dec 2025

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