Transdiagnostic Group Therapy (GBAT) for Autistic Adults With Personalized Therapeutics

Not Applicable

Completed

• Conditions: GBAT+Engagement Booster; GBAT+Individual; GBAT+Both
• Interventions: Other: Watchful Waiting and Groups - Phase 2; Other: GBAT+I, GBAT+E - Phase I; Other: GBAT+IE

• Registration Number: NCT05512221
• Lead Sponsor: Rutgers, The State University of New Jersey

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-19
• Study First Submitted QC: 2022-08-19
• Study First Posted: 2022-08-23
• Study Start: 2022-09-23
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase 2a	Watchful Waiting and Groups - Phase 2	Watchful Waiting, GBAT+I, and GBAT+E groups
Phase I	GBAT+I, GBAT+E - Phase I	GBAT+I and GBAT+E groups
Phase 2b	GBAT+IE	GBAT+IE groups

Primary Outcome Measures

Name	Time	Method
Change in Clinical Global Impression Severity (CGIS) Scale: Independent Evaluator	Change from pre-treatment to post-treatment (an average of 12 weeks)	The CGI-S score provides a global rating of baseline severity ranging from 1 (not at all ill) to 7 (extremely ill), while the CGI-I provides a global rating of clinical improvement ranging from 1 (Very Much Improved) to 7 (Very Much Worse). The IE will provide a baseline CGI ratings for each patient at pretreatment and posttreatment.

Secondary Outcome Measures

Name	Time	Method
Behavior Rating Inventory of Executive Function - Adult Form	Change from pre-treatment to post-treatment (an average of 12 weeks)	The BRIEF is a standardized measure that captures executive functions or self-regulation in an everyday environment. The BRIEF is composed of 75 items within nine theoretically and empirically derived clinical scales that measure various aspects of executive functioning. These scales form a Behavioral Regulation Index and Metacognition Index, as well as an overall Global Executive Composite Each of the scales and indexes yields standardized scores that allow for comparison with adults of the same age and gender (T-scores with a mean of 50 and a standard deviation of 10). T-scores between 60 and 64 are considered "Mildly Elevated," while scores between 65 and 69 are considered "Potentially Clinically Elevated." T-scores above 70 are considered "Clinically Elevated" and may warrant clinical attention.
Distress Tolerance Test	Change from pre-treatment to post-treatment (an average of 12 weeks)	The DTT is a behavioral task that evaluates an individual's willingness to persist at a task in spite of heightened frustration and distress. It uses the stimulus cards from the Wisconsin Card Sort Test. The DTT provides consistently negative feedback over a small number of trials (thus serving as a more "compact" distress induction) and by including the opportunity to escape after 20 trials, which provides a behavioral measure of distress tolerance.
Change in anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7)	Change from pre-treatment to post-treatment (an average of 12 weeks)	The GAD-7, assessed weekly, is a 7-item questionnaire of anxiety symptoms over the past week with all items on a "0" (not at all) to "3"(nearly every day) scale. Total scores range from 0 to 21; higher scores reflect greater levels of anxiety.
Change in distress on Patient Health Questionnaire (PHQ-9)	Change from pre-treatment to post-treatment (an average of 12 weeks)	The PHQ-9 is a 9-item questionnaire of psychological function over the past week with all items on a "0" (not at all) to "3" (nearly every day) scale. Total scores range from 0 to 27; higher scores reflect greater levels of depressive symptoms.
Anxiety Disorders Interview Schedule for DSM-5	Change in CSR from pre-treatment to post-treatment (an average of 12 weeks)	The ADIS-5 is a semi-structured diagnostic interview that assesses mood and anxiety disorders. The interview focuses on clinical threshold of symptoms to inform current diagnostic presentations. Clinician Severity Rating (CSR) is rated for each diagnosis to quantify the interference of symptoms on a scale from 0 ("not at all") to 8 ("debilitating"). A score of 4 and above denotes a clinical threshold.
Mirror Tracing Persistence Task	Change from pre-treatment to post-treatment (an average of 12 weeks)	The MTPT is a behavioral task that evaluates persistence. The participant is asked to trace the outline of 3 stars (rated easy, medium, and difficult), one at a time. The thickness of each subsequent star's outline gets smaller, making it harder to trace. To increase distress, the cursor is programmed to operate in the opposite direction of the user's input. If the participant goes outside the outline, a buzzer sounds and puts the participant back at the start point. Prior to tracing any stars, the participant's affect is assessed using a 100-point scale (0 = none and 100 = extreme) to assess frustration, anxiety, happiness, irritability, difficulty concentrating, and physical discomfort. The participant traces the "difficult" star again, only this time they are given an option to quit. The participant's time is recorded to measure how long they persist on the final star, referred to as task persistence. Afterwards, they rate affect from 0-100 in order to assess change in affect.

Trial Locations

Locations (1)

Rutgers University; 🇺🇸 Piscataway, New Jersey, United States