Emotion Regulation Therapies for Autism

Recruiting at 1 trial location

Overseen By Madison Bradley

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Acute psychosis, Suicide threat, Intoxication, Mania

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: 16-20 weeks

470 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two programs designed to help autistic individuals manage their emotions better. The Emotion Awareness and Skills Enhancement Program (EASE Program) is specifically created for autistic people, while the Unified Protocol is a general therapy aimed at improving emotional skills. The researchers aim to determine if the autism-specific program is more effective. Participants must have a professional autism diagnosis and experience challenges with emotional regulation. The trial is open to those living in Alabama or Pennsylvania who have someone to support them during the study. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance emotional support for autistic individuals.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both the Emotion Awareness and Skills Enhancement (EASE) Program and the Unified Protocol (UP) are treatments that people generally find easy to handle. EASE, a mindfulness-based program, helps individuals with autism better manage their emotions. Studies have found that it improves emotional control without causing significant negative effects, and participants usually manage it well.

The Unified Protocol, a type of cognitive behavioral therapy (CBT), has been widely used to treat emotional issues in various groups, including autistic individuals. Research indicates that it is generally safe, and participants typically tolerate it without serious problems.

Both treatments have been tested in previous studies and are considered safe options for helping autistic individuals with emotional regulation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for autism because they offer unique approaches to managing emotions. The Emotion Awareness and Skills Enhancement (EASE) program is a mindfulness-based intervention that emphasizes mindfulness practices, distress tolerance, encouraging helpful thoughts, and self-compassion, all aimed at increasing awareness of emotional arousal. This is different from traditional therapies, which may not focus as much on mindfulness and self-compassion. On the other hand, The Unified Protocol (UP) offers a customizable cognitive behavioral therapy approach, allowing it to be tailored to individual needs, which is not always possible with standard therapies. Both treatments provide new strategies for emotional regulation, which could offer fresh hope for individuals with autism seeking to better manage their emotions.

What evidence suggests that this trial's treatments could be effective for emotion regulation in autism?

This trial will compare two therapies for emotion regulation in autism: the Emotion Awareness and Skills Enhancement (EASE) program and the Unified Protocol (UP). Research has shown that the EASE program helps autistic individuals manage their emotions better, with studies finding improvements in behavior through mindfulness and self-kindness. Participants in these studies reported better control over their emotions and improved daily life.

For the Unified Protocol (UP), research indicates it effectively reduces emotional issues, such as anxiety, in various situations. It teaches new ways to handle emotions, with studies showing improvements in both children and adults facing emotional challenges. Both therapies in this trial offer promising options for helping autistic individuals manage their emotions more effectively. ^{1 4 6 7 8}

Who Is on the Research Team?

Carla Mazefsky, PhD

Principal Investigator

University of Pittsburgh

Susan White, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for autistic youth and young adults who have difficulty regulating emotions, as indicated by specific scores on the EDI-Reactivity or Dysphoria scale. Participants must have a professional ASD diagnosis, be able to take part meaningfully, and benefit from the study. They need an adult who can complete assessments and live in Alabama or Pennsylvania with internet access for online activities.

Inclusion Criteria

Communicative ability (verbal or nonverbal)

Clinician judgment that person could meaningfully participate and potentially benefit

Professional diagnosis of ASD

Exclusion Criteria

Intoxication

Acute psychosis

Imminent suicide/homicide threat

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the EASE or UP intervention, each consisting of 16 sessions

16-20 weeks

16 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• The Emotion Awareness and Skills Enhancement Program
• The Unified Protocol

Trial Overview

The trial compares two emotion regulation therapies: The Emotion Awareness and Skills Enhancement Program designed specifically for autistic individuals, versus The Unified Protocol. It aims to determine which intervention is more effective when implemented through community agencies.

How Is the Trial Designed?

Group I: The Emotion Awareness and Skills Enhancement Experimental Treatment 1 Intervention

EASE is a 16-session mindfulness-based intervention (MBI). It emphasizes a small set of core concepts (i.e., mindfulness practices, distress tolerance, encouraging helpful thoughts, self-compassion) that are repeated with consistent language throughout. Emphasis is placed on increasing awareness of gradients of emotional arousal.

Group II: The Unified Protocol Active Control 1 Intervention

UP is a 12-21 session cognitive behavioral therapy (CBT) based treatment. In this study, there will be 16 sessions. UP is focused on identifying emotions and building new coping strategies. It is customizable to meet the needs of the individual.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

University of Alabama, Tuscaloosa

Collaborator

Trials

49

Recruited

17,900+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

The Unified Protocol (UP) for treating emotional disorders was found to be effective in improving specific symptoms such as depression and obsessive-compulsive disorder in a study of 243 participants over six months.

Participants receiving the group UP showed greater improvements in depressive symptoms and quality of life compared to those receiving individual Treatment as Usual (TAU), highlighting the UP's efficacy in a public health setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unified Protocol in a Group Format for Improving Specific Symptoms of Emotional Disorders in the Spanish Public Health System. Osma, J., Navarro Haro, MV., Peris Baquero, Ó., et al.[2022]

The Unified Protocol (UP) for treating emotional disorders shows that individual treatment modules can lead to significant improvements in specific skills, even when delivered separately, as evidenced by reliable changes in five out of eight patients.

Preliminary results suggest that the emotional awareness and cognitive flexibility modules are particularly effective in promoting their targeted skills, while psychoeducation and countering emotional behaviors may lead to broader changes across multiple skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isolating the Unique Effects of the Unified Protocol Treatment Modules Using Single Case Experimental Design. Sauer-Zavala, S., Cassiello-Robbins, C., Conklin, LR., et al.[2018]

The Unified Protocol (UP) is an emotion-focused cognitive-behavioral treatment that is being tested in an ongoing randomized controlled trial, showcasing its potential as a transdiagnostic approach for various emotional disorders.

The case example demonstrates how the UP's modular structure allows for tailored treatment, applying specific principles to address the individual needs of the patient, which may enhance its effectiveness across different diagnoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders: A Case Study. Boisseau, CL., Farchione, TJ., Fairholme, CP., et al.[2022]

The Unified Protocol (UP) for treating emotional disorders has shown promising results in a virtual group format, with significant improvements in depression, emotional regulation, and quality of life in a previous pilot study of 7 subjects.

After three months, the positive effects of the UP were maintained, indicating its potential for long-term efficacy in teletherapy settings, although more extensive research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unified Protocol for the transdiagnostic treatment of emotional disorders in virtual and group format in Argentina: three months follow-up of a pilot study Celleri, M., Cremades, CF., Rojas, L., et al.[2023]

The Unified Protocol (UP) for treating emotional disorders was found to be as effective as established single disorder protocols (SDPs) in reducing symptoms of co-occurring emotional disorders among 179 adults, with significant improvements observed from baseline to post-treatment and at 12-month follow-up.

Both treatment approaches led to large reductions in symptoms of generalized anxiety, social anxiety, and depression, indicating that the UP is a viable and potentially more cost-effective option for treating multiple emotional disorders simultaneously.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the Unified Protocol for transdiagnostic treatment of comorbid psychopathology accompanying emotional disorders compared to treatments targeting single disorders. Steele, SJ., Farchione, TJ., Cassiello-Robbins, C., et al.[2019]

A brief online version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders was tested with 19 young adults, showing that 72% attended at least four out of five sessions, indicating good feasibility for this format.

Participants reported that key concepts from the therapy, like understanding emotions and mindfulness, were useful in their daily lives, and there was a significant reduction in anxiety-related life impairment at the 12-week follow-up compared to baseline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a brief, online transdiagnostic psychotherapy for young adults. Dimitropoulos, G., Lindenbach, D., Rowbotham, M., et al.[2023]

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