Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05862467
Status:
RECRUITING
Last Update Posted:
2023-12-13
First Post:
2023-04-25
Brief Title:
A Pilot Participatory Program Evaluation of a Virtual Trauma Support Program for Autistic Adults
Sponsor:
University of Wyoming
Organization:
University of Wyoming
Study Overview
Official Title:
Efficacy of a Posttraumatic Stress Disorder PTSD Intervention for Autistic Adults on Biobehavioral Health
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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
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 eg 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None