CClinicalTrials.gg
CompletedNCT05862467Updated Jul 2, 2026Results posted

A Pilot Participatory Program Evaluation of a Virtual Trauma Support Program for Autistic Adults

An interventional study of Written Exposure Therapy (WET) via telehealth in Autism, Trauma and Posttraumatic Stress Disorder, sponsored by University of Wyoming. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.

Sponsored by University of Wyoming · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Autism
  • Trauma
  • Posttraumatic Stress Disorder
  • Posttraumatic Stress Symptom
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Autistic
  • 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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Written Exposure Therapy

    Behavioral therapy: Written Exposure Therapy via telehealth

    Behavioral: Written Exposure Therapy (WET) via telehealth

Interventions

  • BehavioralWritten Exposure Therapy (WET) via telehealth

    Written Exposure Therapy (WET) via telehealth

05

What researchers measure

Primary outcomes

  1. Change in Posttraumatic Stress Disorder (PTSD) Symptoms on the Posttraumatic Symptom Checklist for DSM-5 (PCL-5) Scale

    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.

    Time frame: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)

Secondary outcomes

  1. Change in Depressive Symptoms on the Patient Health Questionnaire (PHQ) Scale

    The PHQ is a self-report measure of depressive symptoms. Total scores range from 0-27; higher scores reflect greater levels of depressive symptoms.

    Time frame: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)

  2. Change in Anxiety Symptoms on the Anxiety Scale for Autism-Adults (ASA-A)

    The Anxiety Scale for Autism-Adults (ASA-A) is a self-report measure for anxiety symptoms among autistic adults. Total scores range from 0 to 60; higher scores reflect higher anxiety symptoms.

    Time frame: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)

  3. Change in Loneliness Symptoms on the University of California Los Angeles (UCLA) 3-Item Loneliness Scale

    The University of California Los Angeles (UCLA) 3-Item Loneliness Scale is a self-report measure for symptoms of loneliness. Scores range from 3 to 9; higher scores reflect higher levels of loneliness.

    Time frame: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)

  4. Change in Psychological Adjustment Concerns on the Brief Adjustment Scale (BASE-6)

    The Brief Adjustment Scale (BASE-6) is a brief self-report symptom monitoring measure for general psychological adjustment. Scores from from 6 to 42; higher scores reflect greater psychological adjustment concerns.

    Time frame: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)

  5. Change in Experiential Avoidance Symptoms on the Brief Experiential Avoidance Questionnaire

    The Brief Experiential Avoidance Questionnaire is a self-report measure of experiential avoidance. Scores range from 15 to 90; higher scores reflect greater levels of experiential avoidance.

    Time frame: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)

  6. Change in Emotion Regulation Difficulties on the Difficulties in Emotion Regulation Scale (DERS-16)

    The Difficulties in Emotion Regulation Scale (DERS-16) is a self-report measure of emotion regulation difficulties. Scores range from 16 to 80; higher scores reflect greater emotion regulation difficulties.

    Time frame: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)

  7. Change in Stigma Towards Help-seeking on the Ultra-Brief Self-Stigma of Seeking Help (SSOSH-3) Scale

    The Ultra Brief Self-Stigma of Seeking Help (SSOSH-3) Scale is a self-report measure of stigma towards seeking psychological support. Scores range from 3 to 15; higher scores reflect greater stigma.

    Time frame: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)

  8. Change in Camouflaging on the Camouflaging Autistic Traits Questionnaire (CATQ)

    The Camouflaging Autistic Traits Questionnaire (CATQ) is a self-report measure of masking autistic traits. Scores range from 25 to 175; greater scores reflect a higher level of camouflaging.

    Time frame: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)

  9. Change in Sleep Difficulties on the Pittsburgh Sleep Quality Index (PSQI)

    The Pittsburgh Sleep Quality Index (PSQI) is a self-report measure of sleep difficulties. Scores range from 0 to 21; higher scores reflect greater sleep difficulties.

    Time frame: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)

  10. Change in Pain Intensity on the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form Scale.

    The Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form Scale is a self-report measure of pain intensity. Total scores range from 3 to 15; higher scores reflect more intense pain.

    Time frame: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)

  11. Change in Pain Interference on the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Short Form Scale.

    The Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Short Form Scale is a self-report measure of pain interference. Total scores range from 8 to 40; higher scores reflect a greater level of pain interference.

    Time frame: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)

  12. Change in Physical Activity as Assessed on Fitbit.

    Participants Fitbit measurements of number of steps (average past week daily steps) will be assessed via their Fitbit device.

    Time frame: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)

  13. Change in Sleep Duration as Assessed on Fitbit.

    Participants Fitbit measurements of sleep duration in hours (past weekly nightly average in hours) will be assessed via their Fitbit device. A higher sleep duration indicates greater numbers slept.

    Time frame: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)

  14. Change in Resting Heart Rate as Assessed on Fitbit.

    Participants Fitbit measurements of resting heart rate (past week daily average) will be assessed via their Fitbit device.

    Time frame: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)

Other outcomes

  1. Change in Autistic Quality of Life on the Autism Spectrum Quality of Life Scale.

    The Autism Spectrum Quality of Life Scale is a self-report measure of quality of life relating to autism. Total scores range from 9 to 45, and higher scores reflect greater quality of life.

    Time frame: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)

  2. Change in Overall Quality of Life on the World Health Organization Quality of Life Scale

    The World Health Organization Quality of Life Scale (WHO QOL) is a 26-item self-report questionnaire of quality of life. Summed total scores range from 26 to 130, and higher scores reflect greater quality of life.

    Time frame: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)

  3. Change in Positive Autistic Identity on the Autism Spectrum Identity Scale (ASIS)

    The Autism Spectrum Identity Scale (ASIS) is a 22-item self-report of autistic identity. Total scores range from 22 to 110, and higher scores reflect a more positive Autistic identity.

    Time frame: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)

06

Results

Posted Jul 2, 2026
Limitations and caveats
This study was a pilot feasibility study with a single arm pre-post design and a small sample size, with no randomization.

Participant flow

Autistic adults were enrolled in this study from October 2023 to July 2024. Participants were recruited through flyers and advertisements posted to social media, listservs, and clinic emails.

Enrollment to End of Intervention
Participant flow — Enrollment to End of Intervention
MilestoneWritten Exposure Therapy
Started28
Completed23
Not completed5
1 Month Follow Up
Participant flow — 1 Month Follow Up
MilestoneWritten Exposure Therapy
Started23
Completed19
Not completed4
6 Month Follow Up
Participant flow — 6 Month Follow Up
MilestoneWritten Exposure Therapy
Started19
Completed18
Not completed1

Outcome measures

PrimaryChange in Posttraumatic Stress Disorder (PTSD) Symptoms on the Posttraumatic Symptom Checklist for DSM-5 (PCL-5) Scale

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.

Time frame:
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Reported as:
Mean · Score on a Scale
Change in Posttraumatic Stress Disorder (PTSD) Symptoms on the Posttraumatic Symptom Checklist for DSM-5 (PCL-5) Scale
Score on a ScaleWritten Exposure Therapy
Baseline40.64 ± 13.54
End of Intervention22.00 ± 16.01
1 Month Follow-Up19.11 ± 13.73
6 Month Follow-Up17.82 ± 15.96
SecondaryChange in Depressive Symptoms on the Patient Health Questionnaire (PHQ) Scale

The PHQ is a self-report measure of depressive symptoms. Total scores range from 0-27; higher scores reflect greater levels of depressive symptoms.

Time frame:
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Reported as:
Mean · Score on a Scale
Change in Depressive Symptoms on the Patient Health Questionnaire (PHQ) Scale
Score on a ScaleWritten Exposure Therapy
Baseline14.25 ± 4.56
End of Intervention9.83 ± 5.45
1 Month Follow-Up9.79 ± 5.37
6 Month Follow-Up9.44 ± 5.35
SecondaryChange in Anxiety Symptoms on the Anxiety Scale for Autism-Adults (ASA-A)

The Anxiety Scale for Autism-Adults (ASA-A) is a self-report measure for anxiety symptoms among autistic adults. Total scores range from 0 to 60; higher scores reflect higher anxiety symptoms.

Time frame:
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Reported as:
Mean · Score on a Scale
Change in Anxiety Symptoms on the Anxiety Scale for Autism-Adults (ASA-A)
Score on a ScaleWritten Exposure Therapy
Baseline33.79 ± 8.40
End of Intervention28.86 ± 10.43
1 Month Follow-Up26.63 ± 9.95
6 Month Follow-Up23.47 ± 9.73
SecondaryChange in Loneliness Symptoms on the University of California Los Angeles (UCLA) 3-Item Loneliness Scale

The University of California Los Angeles (UCLA) 3-Item Loneliness Scale is a self-report measure for symptoms of loneliness. Scores range from 3 to 9; higher scores reflect higher levels of loneliness.

Time frame:
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Reported as:
Mean · Score on a Scale
Change in Loneliness Symptoms on the University of California Los Angeles (UCLA) 3-Item Loneliness Scale
Score on a ScaleWritten Exposure Therapy
Baseline7.68 ± 1.61
End of Intervention7.24 ± 1.97
1 Month Follow-Up7.16 ± 1.46
6 Month Follow-Up6.65 ± 1.84
SecondaryChange in Psychological Adjustment Concerns on the Brief Adjustment Scale (BASE-6)

The Brief Adjustment Scale (BASE-6) is a brief self-report symptom monitoring measure for general psychological adjustment. Scores from from 6 to 42; higher scores reflect greater psychological adjustment concerns.

Time frame:
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Reported as:
Mean · Score on a Scale
Change in Psychological Adjustment Concerns on the Brief Adjustment Scale (BASE-6)
Score on a ScaleWritten Exposure Therapy
Baseline26.93 ± 5.44
End of Intervention22.70 ± 9.75
1 Month Follow-Up20.95 ± 7.47
6 Month Follow-Up20.06 ± 9.25
SecondaryChange in Experiential Avoidance Symptoms on the Brief Experiential Avoidance Questionnaire

The Brief Experiential Avoidance Questionnaire is a self-report measure of experiential avoidance. Scores range from 15 to 90; higher scores reflect greater levels of experiential avoidance.

Time frame:
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Reported as:
Mean · Score on a Scale
Change in Experiential Avoidance Symptoms on the Brief Experiential Avoidance Questionnaire
Score on a ScaleWritten Exposure Therapy
Baseline57.59 ± 10.36
End of Intervention51.10 ± 12.05
1 Month Follow-Up49.79 ± 12.37
6 Month Follow-Up47.82 ± 12.01
SecondaryChange in Emotion Regulation Difficulties on the Difficulties in Emotion Regulation Scale (DERS-16)

The Difficulties in Emotion Regulation Scale (DERS-16) is a self-report measure of emotion regulation difficulties. Scores range from 16 to 80; higher scores reflect greater emotion regulation difficulties.

Time frame:
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Reported as:
Mean · Score on a Scale
Change in Emotion Regulation Difficulties on the Difficulties in Emotion Regulation Scale (DERS-16)
Score on a ScaleWritten Exposure Therapy
Baseline53.52 ± 11.28
End of Intervention47.80 ± 14.29
1 Month Follow-Up46.74 ± 13.47
6 Month Follow-Up45.41 ± 12.81
SecondaryChange in Stigma Towards Help-seeking on the Ultra-Brief Self-Stigma of Seeking Help (SSOSH-3) Scale

The Ultra Brief Self-Stigma of Seeking Help (SSOSH-3) Scale is a self-report measure of stigma towards seeking psychological support. Scores range from 3 to 15; higher scores reflect greater stigma.

Time frame:
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Reported as:
Mean · Score on a Scale
Change in Stigma Towards Help-seeking on the Ultra-Brief Self-Stigma of Seeking Help (SSOSH-3) Scale
Score on a ScaleWritten Exposure Therapy
Baseline5.25 ± 3.13
End of Intervention4.50 ± 2.70
1 Month Follow-Up4.63 ± 2.45
6 Month Follow-Up4.47 ± 1.94
SecondaryChange in Camouflaging on the Camouflaging Autistic Traits Questionnaire (CATQ)

The Camouflaging Autistic Traits Questionnaire (CATQ) is a self-report measure of masking autistic traits. Scores range from 25 to 175; greater scores reflect a higher level of camouflaging.

Time frame:
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Reported as:
Mean · Score on a Scale
Change in Camouflaging on the Camouflaging Autistic Traits Questionnaire (CATQ)
Score on a ScaleWritten Exposure Therapy
Baseline137.07 ± 19.46
End of Intervention128.33 ± 25.19
1 Month Follow-Up128.44 ± 22.59
6 Month Follow-Up126.24 ± 18.05
SecondaryChange in Sleep Difficulties on the Pittsburgh Sleep Quality Index (PSQI)

The Pittsburgh Sleep Quality Index (PSQI) is a self-report measure of sleep difficulties. Scores range from 0 to 21; higher scores reflect greater sleep difficulties.

Time frame:
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Reported as:
Mean · Score on a Scale
Change in Sleep Difficulties on the Pittsburgh Sleep Quality Index (PSQI)
Score on a ScaleWritten Exposure Therapy
Baseline10.64 ± 3.87
End of Intervention9.42 ± 2.81
1 Month Follow-Up9.86 ± 4.20
6 Month Follow-Up10.14 ± 4.04
SecondaryChange in Pain Intensity on the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form Scale.

The Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form Scale is a self-report measure of pain intensity. Total scores range from 3 to 15; higher scores reflect more intense pain.

Time frame:
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Reported as:
Mean · Score on a Scale
Change in Pain Intensity on the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form Scale.
Score on a ScaleWritten Exposure Therapy
Baseline11.15 ± 4.36
End of Intervention10.55 ± 4.93
1 Month Follow-Up9.89 ± 5.51
6 Month Follow-Up10.20 ± 5.02
SecondaryChange in Pain Interference on the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Short Form Scale.

The Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Short Form Scale is a self-report measure of pain interference. Total scores range from 8 to 40; higher scores reflect a greater level of pain interference.

Time frame:
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Reported as:
Mean · Score on a Scale
Change in Pain Interference on the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Short Form Scale.
Score on a ScaleWritten Exposure Therapy
Baseline19.61 ± 9.41
End of Intervention18.85 ± 9.88
1 Month Follow-Up18.05 ± 10.39
6 Month Follow-Up16.53 ± 8.55
SecondaryChange in Physical Activity as Assessed on Fitbit.

Participants Fitbit measurements of number of steps (average past week daily steps) will be assessed via their Fitbit device.

Time frame:
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Reported as:
Mean · Number of steps
Change in Physical Activity as Assessed on Fitbit.
Number of stepsWritten Exposure Therapy
Baseline6967.60 ± 3689.05
End of Intervention6846.04 ± 4339.02
1 Month Follow-Up6381.08 ± 3244.95
6 Month Follow-Up4658.71 ± 1549.74
SecondaryChange in Sleep Duration as Assessed on Fitbit.

Participants Fitbit measurements of sleep duration in hours (past weekly nightly average in hours) will be assessed via their Fitbit device. A higher sleep duration indicates greater numbers slept.

Time frame:
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Reported as:
Mean · Hours
Change in Sleep Duration as Assessed on Fitbit.
HoursWritten Exposure Therapy
Baseline7.13 ± 1.18
End of Intervention7.13 ± 1.89
1 Month Follow-Up7.02 ± 1.05
6 Month Follow-Up7.05 ± 1.20
SecondaryChange in Resting Heart Rate as Assessed on Fitbit.

Participants Fitbit measurements of resting heart rate (past week daily average) will be assessed via their Fitbit device.

Time frame:
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Reported as:
Mean · Beats per minute/day
Change in Resting Heart Rate as Assessed on Fitbit.
Beats per minute/dayWritten Exposure Therapy
Baseline68.17 ± 7.69
End of Intervention68.25 ± 7.24
1 Month Follow-Up68.35 ± 8.35
6 Month Follow-Up70.53 ± 8.21
Other pre-specifiedChange in Autistic Quality of Life on the Autism Spectrum Quality of Life Scale.

The Autism Spectrum Quality of Life Scale is a self-report measure of quality of life relating to autism. Total scores range from 9 to 45, and higher scores reflect greater quality of life.

Time frame:
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Reported as:
Mean · Score on a Scale
Change in Autistic Quality of Life on the Autism Spectrum Quality of Life Scale.
Score on a ScaleWritten Exposure Therapy
Baseline27.79 ± 5.01
End of Intervention28.57 ± 5.52
1 Month Follow-Up28 ± 4.88
6 Month Follow-Up28.94 ± 3.67
Other pre-specifiedChange in Overall Quality of Life on the World Health Organization Quality of Life Scale

The World Health Organization Quality of Life Scale (WHO QOL) is a 26-item self-report questionnaire of quality of life. Summed total scores range from 26 to 130, and higher scores reflect greater quality of life.

Time frame:
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Reported as:
Mean · Score on a Scale
Change in Overall Quality of Life on the World Health Organization Quality of Life Scale
Score on a ScaleWritten Exposure Therapy
Baseline77.07 ± 16.02
End of Intervention78.24 ± 16.43
1 Month Follow-Up80.89 ± 16.22
6 Month Follow-Up80.41 ± 16.81
Other pre-specifiedChange in Positive Autistic Identity on the Autism Spectrum Identity Scale (ASIS)

The Autism Spectrum Identity Scale (ASIS) is a 22-item self-report of autistic identity. Total scores range from 22 to 110, and higher scores reflect a more positive Autistic identity.

Time frame:
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Reported as:
Mean · Score on a Scale
Change in Positive Autistic Identity on the Autism Spectrum Identity Scale (ASIS)
Score on a ScaleWritten Exposure Therapy
Baseline61.82 ± 9.79
End of Intervention61.75 ± 10.03
1 Month Follow-Up61.94 ± 12.58
6 Month Follow-Up58.00 ± 11.95

Adverse events

Collected over From enrollment until end of follow-up, up to 6 months after intervention completion. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Written Exposure Therapy0/28 (0%)0/28 (0%)0/28 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Written Exposure Therapy
Mean37.25 ± 11.60
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Written Exposure Therapy
Sex/Gender — Female20
Sex/Gender — Male3
Sex/Gender — Unknown/Not Reported5
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Written Exposure Therapy
American Indian or Alaska Native1
Asian2
Native Hawaiian or Other Pacific Islander0
Black or African American1
White21
More than one race2
Unknown or Not Reported1
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Written Exposure Therapy
Hispanic or Latino2
Not Hispanic or Latino26
Unknown or Not Reported0
Posttraumatic Symptom Checklist for DSM-5 (PCL-5) Scale
Posttraumatic Symptom Checklist for DSM-5 (PCL-5) Scale(Score on scale)Written Exposure Therapy
Mean40.64 ± 13.54
07

Study locations

1 site
  • University of Wyoming
    Laramie, Wyoming 82071, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 30, 2026

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT05862467
Lead sponsor
University of Wyoming
Responsible party
Sponsor
First posted
May 17, 2023
Start date
Oct 26, 2023
Primary completion
Feb 12, 2025
Completion
Feb 12, 2025
Results posted
Jul 2, 2026
Last update
Jul 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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