Efficacy of a Posttraumatic Stress Disorder (PTSD) Intervention for Autistic Adults on Biobehavioral Health

University of Wyoming1 site in 1 country28 target enrollmentOctober 26, 2023

ConditionsAutism Trauma Posttraumatic Stress Disorder Posttraumatic Stress Symptom

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Autism
Sponsor: University of Wyoming
Enrollment: 28
Locations: 1
Primary Endpoint: Change in posttraumatic stress disorder (PTSD) symptoms on the Posttraumatic Symptom Checklist for DSM-5 (PCL-5) Scale
Status: Completed
Last Updated: 12 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this single-group clinical trial is to learn about the initial efficacy and feasibility of telehealth-delivered Written Exposure Therapy (WET) for autistic adults with traumatic stress symptoms. The main questions the investigators aim to answer are:

Do symptoms of posttraumatic stress disorder (PTSD) and co-occurring mental health concerns decrease after receiving WET?
Do biobehavioral health outcomes, including objective (Fitbit indicators of activity, sleep, and heart rate) and subjectively-reported health variables (e.g., sleep, pain, health-related quality of life), improve after receiving WET?
How do autistic adults experience WET, and how can this program be modified and enhance in the future in collaboration with autistic adults?

Participants will complete the following as part of the study, which is completed entirely over telehealth.

Participants will first complete an initial assessment, involving brief measures of cognition and autistic traits, as well as interviews and questionnaires about PTSD, mental health, and physical health. If eligible, participants will proceed to the following steps:
Eligible participants will then start wearing a Fitbit, to be used for the duration of the study.
Participants will then participate in 5 weekly virtual visits involving the WET protocol, including weekly brief assessment of PTSD and mental and physical health.
Then, participants will complete a sixth virtual visit the following week where PTSD, mental and physical health, and treatment feedback are assessed.
Lastly, participants will complete virtual visits 1 and 6 months later involving re-assessment of PTSD and mental and physical health.

Therefore, this is a pre-post single group design, where all participants will receive WET to establish initial efficacy and feasibility. Investigators will also consult with an autistic advisory board throughout the project, and make adaptations as recommended in consultation with autistic adults. The goal is to better understand the initial efficacy and feasibility of WET for supporting autistic adults who have experienced trauma.

Registry

clinicaltrials.gov

Start Date

October 26, 2023

End Date

February 12, 2025

Last Updated

12 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Wyoming

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18 years or over
•Has experienced trauma and reports clinically significant symptoms of traumatic stress (clinically elevated score on either Posttraumatic Symptom Checklist (PCL-5) or Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID-5), and/or other self-report/interview evidence of significant traumatic stress symptoms for which participant wants support/program
•Comfortable speaking and writing in English
•Full Scale Intelligence Quotient (FSIQ) score \>= 65 (given written nature of Written Exposure Therapy) on the Wechsler Abbreviated Scale of Intelligence-Second Edition (WASI-2)
•Access to device with internet access for telehealth visits

Exclusion Criteria

•Participant is not Autistic
•Participant is unable to understand English
•Participant is currently receiving trauma-focused therapeutic services
•Participant does not have access to internet connected device for telehealth visits
•Participant receives Full Scale Intelligence Quotient (FSIQ) score \< 65 on the Wechsler Abbreviated Scale of Intelligence-Second Edition (WASI-2)
•If there are significant safety concerns for any participant (e.g., imminent risk of harm to self or other) the Principal Investigator may determine whether it is not in the adult's best interest to be enrolled given that this study does not provide care/services relating to active risk.

Outcomes

Primary Outcomes

Change in posttraumatic stress disorder (PTSD) symptoms on the Posttraumatic Symptom Checklist for DSM-5 (PCL-5) Scale

Time Frame: Change across baseline to follow-up (an average of 6 months)

The Posttraumatic Symptom Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 is a self-report questionnaire of posttraumatic stress disorder symptoms. Total scores range from 0-80; higher scores indicate higher levels of posttraumatic stress disorder symptoms.

Secondary Outcomes

Change in depressive symptoms on the Patient Health Questionnaire (PHQ) Scale(Change across baseline to follow-up (an average of 6 months))
Change in anxiety symptoms on the Anxiety Scale for Autism-Adults (ASA-A)(Change across baseline to follow-up (an average of 6 months))
Change in camouflaging on the Camouflaging Autistic Traits Questionnaire (CATQ)(Change across baseline to follow-up (an average of 6 months))
Change in pain intensity on the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form Scale.(Change across baseline to follow-up (an average of 6 months))
Change in emotion regulation difficulties on the Difficulties in Emotion Regulation Scale (DERS-16)(Change across baseline to follow-up (an average of 6 months))
Change in pain interference on the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Short Form Scale.(Change across baseline to follow-up (an average of 6 months))
Change in sleep quality as assessed on Fitbit.(Change across baseline to follow-up (an average of 6 months))
Change in psychological adjustment concerns on the Brief Adjustment Scale (BASE-6)(Change across baseline to follow-up (an average of 6 months))
Change in experiential avoidance symptoms on the Brief Experiential Avoidance Questionnaire(Change across baseline to follow-up (an average of 6 months))
Change in PTSD symptoms on the clinician-administered Structured Clinical Interview for DSM-5(Change across baseline to follow-up (an average of 6 months))
Change in sleep duration as assessed on Fitbit.(Change across baseline to follow-up (an average of 6 months))
Change in resting heart rate as assessed on Fitbit.(Change across baseline to follow-up (an average of 6 months))
Change in loneliness symptoms on the University of California Los Angeles (UCLA) 3-Item Loneliness Scale(Change across baseline to follow-up (an average of 6 months))
Change in physical activity as assessed on Fitbit.(Change across baseline to follow-up (an average of 6 months))
Change in stigma towards help-seeking on the Ultra-Brief Self-Stigma of Seeking Help (SSOSH-3) Scale(Change across baseline to follow-up (an average of 6 months))
Change in sleep difficulties on the Pittsburgh Sleep Quality Index (PSQI)(Change across baseline to follow-up (an average of 6 months))
Change in health-related quality of life on the Centers for Disease Control Health-Related Quality of Life Scale (CDC HRQOL)(Change across baseline to follow-up (an average of 6 months))