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Group Behavioral Activation Therapy for Autism ((GBAT+) Trial)

N/A
Recruiting
Led By Vanessa Bal, PhD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from pre-treatment to post-treatment (an average of 12 weeks)
Awards & highlights

(GBAT+) Trial Summary

This trial will compare the feasibility, acceptability, and preliminary efficacy of three adapted versions of Group Behavioral Activation Therapy (GBAT) delivered via telehealth, compared to a Watchful Waiting (WW) group, in autistic adults with anxiety and depression.

Who is the study for?
This trial is for autistic adults aged 18-40 living in New Jersey or New York, who can participate in online sessions and have at least a 6th-grade reading level. They should be diagnosed with an anxiety or mood disorder but not currently receiving other behavioral therapies for these conditions. Individuals with severe suicidal ideation, intellectual disabilities, schizophrenia, bipolar disorder, or those unable to understand English fluently are excluded.Check my eligibility
What is being tested?
The study tests Group Behavioral Activation Therapy (GBAT) delivered via telehealth to treat anxiety and depression symptoms in autistic adults. It compares three GBAT adaptations: individual supplement sessions (GBAT+I), engagement boosters (GBAT+E), both combined (GBAT+IE), against a Watchful Waiting group over ten weeks.See study design
What are the potential side effects?
As this is a psychological therapy trial rather than medication-based, side effects may include emotional discomfort during discussions of personal issues or increased awareness of one's mental health condition. No physical side effects are expected from the interventions.

(GBAT+) Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from pre-treatment to post-treatment (an average of 12 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from pre-treatment to post-treatment (an average of 12 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Clinical Global Impression Severity (CGIS) Scale: Independent Evaluator
Secondary outcome measures
Anxiety Disorders
Behavior Rating Inventory of Executive Function - Adult Form
Anxiety Disorders
+3 more

(GBAT+) Trial Design

3Treatment groups
Experimental Treatment
Group I: Phase IExperimental Treatment1 Intervention
GBAT+I and GBAT+E groups
Group II: Phase 2bExperimental Treatment1 Intervention
GBAT+IE groups
Group III: Phase 2aExperimental Treatment1 Intervention
Watchful Waiting, GBAT+I, and GBAT+E groups

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,202 Total Patients Enrolled
New Jersey Governor's Council for Medical Research and Treatment of AutismUNKNOWN
1 Previous Clinical Trials
6 Total Patients Enrolled
Vanessa Bal, PhDPrincipal InvestigatorRutgers, The State University of New Jersey
1 Previous Clinical Trials
15 Total Patients Enrolled

Media Library

Transdiagnostic Group Therapy (GBAT) Clinical Trial Eligibility Overview. Trial Name: NCT05512221 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals over the age of 40 being invited to participate in this medical trial?

"This trial is only open to patients aged 18-40. For those under the age of 18, there are 162 other trials available, and 28 for seniors above 65 years old."

Answered by AI

Are there any current vacancies for participants in this evaluation?

"According to clinicaltrials.gov, this investigation is currently accepting applicants and was initially posted on September 23rd 2022 before being recently modified on October 25th 2022."

Answered by AI

What criteria must individuals meet in order to qualify for this research program?

"This clinical investigation seeks 30 individuals with autism aged 18 to 40. Applicants must bear the following credentials: Be between 18 and 40 years old, Have a verified diagnosis of Autism Spectrum Disorder (ASD), Possess access to an electronic device such as a computer or smartphone in order to complete questionnaires and join virtual meetings, Achieve WRAT Reading Comprehension grade equivalent 6th grade or higher, Reside within New york or New jersey state limits, Express interest in joining a telehealth treatment group that focuses on areas of difficulty mentioned above., Approximately 60% should be White Non-Hispanic; female applicants ought to account for around 40%,"

Answered by AI

How many participants are currently receiving treatment in this experiment?

"Affirmative. Per the information located on clinicaltrials.gov, this study is still enrolling participants and was originally published on September 23rd 2022. The trial requires 30 patients to be recruited from one site with the most recent update occurring October 25th 2022."

Answered by AI

Who else is applying?

What state do they live in?
New York
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Rutgers University
What portion of applicants met pre-screening criteria?
Met criteria
~1 spots leftby Jun 2024