Emotion Regulation Therapies for Autism

Recruiting at 1 trial location

Overseen By Anna-Lisa Pflaum

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

Trial Summary

What is the purpose of this trial?

Too few clinicians are able and willing to help autistic patients. A recent review identified challenges to mental health service delivery in autism, including a lack of interventions designed for community implementation and limited workforce capacity. It has been argued that improving impairment in emotion regulation has the potential to improve a range of mental health difficulties in autistic people. In this clinical trial, the investigators are comparing two evidence-based interventions for emotion regulation, to determine if one created specifically for autistic people is clinically superior. The interventions will be implemented in the community, through partnering agencies.

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.

What data supports the effectiveness of the treatment The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders?

Research shows that the Unified Protocol (UP) is effective in reducing symptoms of emotional disorders like anxiety and depression, and it improves emotional regulation and quality of life. It works well in both group and virtual formats, making it a flexible option for treating various emotional issues. ^{1 2 3 4 5}

Is the Unified Protocol safe for humans?

The Unified Protocol (UP) has been studied in various formats and settings, including group and virtual formats, and has shown to be effective for treating emotional disorders without any reported safety concerns in humans. ^{1 2 3 4 6}

How is the Emotion Awareness and Skills Enhancement Program (EASE) different from other treatments for autism?

The Emotion Awareness and Skills Enhancement Program (EASE), part of the Unified Protocol, is unique because it is a flexible cognitive-behavioral therapy designed to address a range of emotional disorders by focusing on emotional awareness and regulation. Unlike treatments targeting specific disorders, EASE can be personalized to fit individual needs, making it adaptable for various emotional challenges associated with autism. ^{1 2 3 4 6}

Research Team

Carla Mazefsky, PhD

Principal Investigator

University of Pittsburgh

Susan White, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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) 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 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]

References

1. Spain pubmed.ncbi.nlm.nih.gov

Unified Protocol in a Group Format for Improving Specific Symptoms of Emotional Disorders in the Spanish Public Health System. [2022]

2. England 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. [2019]

3. Canada pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a brief, online transdiagnostic psychotherapy for young adults. [2023]

4. Argentina 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 [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The Development of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders: A Case Study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Isolating the Unique Effects of the Unified Protocol Treatment Modules Using Single Case Experimental Design. [2018]