Clinical trial NCT05512221: Transdiagnostic Group Therapy (GBAT) for Autistic Adults With Personalized Therapeutics
Official title: Optimizing Engagement and Reach of a Transdiagnostic Group Therapy for Autistic Adults Through Technology and Personalized Therapeutics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: GBAT+Individual
GBAT+Engagement Booster
GBAT+Both
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: New Jersey Governor's Council for Medical Research and Treatment of Autism
First posted: 2022-08-23
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to build upon an earlier study that evaluated the use of a 10-week transdiagnostic Group Behavioral Activation Therapy (GBAT), a telehealth delivered intervention, as a cost effective and accessible way to treat symptoms of anxiety and depression in autistic adults. The current study will pilot and compare relative feasibility, acceptability, and preliminary efficacy of three adapted GBAT groups and a Watchful Waiting (WW) group. The three groups include GBAT+Individual (GBAT+I; individual sessions to supplement the 10 group sessions), GBAT+Engagement Booster (GBAT+E; supplemental materials), and GBAT+Both (GBAT+IE individual sessions and supplemental materials).


Eligibility criteria: Inclusion Criteria:

* Live in New Jersey or New York
* Be 18-40 years old
* Have a confirmed diagnosis of Autism Spectrum Disorders (ASD).
* Have access to a device (e.g., computer with a webcam or smartphone) in order to complete online surveys and participate in videoconference sessions
* WRAT Reading Comprehension grade equivalent 6th grade or higher
* Receive a best-estimate diagnosis of an anxiety or mood disorder (Generalized Anxiety Disorder, Social Anxiety Disorder, Specific Phobia, Panic Disorder, Agoraphobia, Major Depressive Disorder, Unspecified Depression, Persistent Depressive Disorder).
* Be interested in participating in an online telehealth treatment group to address their difficulties in the aforementioned areas
* Approximately 60% of our sample will be White, Non-Hispanic; approximately 40% of our sample will be female-identifying and 40% will be male-identifying

Exclusion Criteria:

* Are younger than 18 years old, or older than 40 years old
* Do not have an ASD diagnosis
* Have WRAT Reading Comprehension below 6th grade level
* Are unable to understand English fluently
* Have a principal DSM-5 disorder other than one of the above listed anxiety or depression disorders, have received a diagnosis of Intellectual Disability, schizophrenia, or bipolar disorder or demonstrate suicidal ideation or intent severe enough to require current hospitalization, or who have attempted suicide in the past 3 months.
* Are currently enrolled in another behavioral therapy or psychotherapy targeting depression, anxiety or anger.
* Are experiencing suicidal ideation that requires current hospitalization.
* The PI's best clinical judgment that it would not be in the adult's best interest to be enrolled (e.g., due to factors that may affect their engagement or comfort in the group).

Primary outcomes:
measure: Change in Clinical Global Impression Severity (CGIS) Scale: Independent Evaluator
timeFrame: Change from pre-treatment to post-treatment (an average of 12 weeks)
Secondary outcomes:
measure: Change in distress on Patient Health Questionnaire (PHQ-9)
timeFrame: Change from pre-treatment to post-treatment (an average of 12 weeks)
measure: Change in anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7)
timeFrame: Change from pre-treatment to post-treatment (an average of 12 weeks)
measure: Anxiety Disorders Interview Schedule for DSM-5
timeFrame: Change in CSR from pre-treatment to post-treatment (an average of 12 weeks)
measure: Behavior Rating Inventory of Executive Function - Adult Form
timeFrame: Change from pre-treatment to post-treatment (an average of 12 weeks)
measure: Mirror Tracing Persistence Task
timeFrame: Change from pre-treatment to post-treatment (an average of 12 weeks)
measure: Distress Tolerance Test
timeFrame: Change from pre-treatment to post-treatment (an average of 12 weeks)
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Rutgers University
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Vanessa Bal, PhD
role: PRINCIPAL_INVESTIGATOR
References: