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Virtual Asynchronous Treatment for Psychological Trauma

N/A
Waitlist Available
Led By Dana C. Ross, MD, MSc
Research Sponsored by Women's College Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged > 18 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial aims to test an online trauma therapy program, Trauma PORTAL, to increase access to mental health services and reduce trauma-related symptoms. It includes 8 modules with an optional weekly virtual group session. Results from a pilot study show good feasibility, acceptability and improvement in PTSD symptoms.

Who is the study for?
This trial is for adults over 18 who experienced childhood interpersonal trauma before age 18 and have PTSD. They must have internet access, attended an orientation at WCH, and be deemed suitable by a TTP therapist. Exclusions include recent substance abuse or psychiatric hospitalization, non-English speakers, and those with mania, psychosis, or active suicidal thoughts.Check my eligibility
What is being tested?
The Trauma PORTAL Project tests a virtual asynchronous treatment program for PTSD from childhood trauma. It's compared to standard therapy in a randomized controlled trial. Participants use online modules at their own pace with optional weekly live sessions to discuss content.See study design
What are the potential side effects?
Since this intervention involves psychological therapy rather than medication, side effects may include emotional discomfort or distress while discussing traumatic experiences but are not the typical physical side effects seen with drug treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am older than 18 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score
Secondary outcome measures
Change in Clinician-Administered Post-Traumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Past Month score (CAPS-5 Past Month) score
Change in Difficulties in Emotion Regulation Scale (DERS-18) score
Change in Short Self-Compassion Scale (Short SCS) score
Other outcome measures
Acceptability of intervention in the target population
Change in Health Service Utilization Questionnaire responses
General Internet Attitude Scale
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Trauma PORTAL InterventionExperimental Treatment1 Intervention
The treatment group will complete the Trauma PORTAL intervention in 9 weeks. The participants will be asked to complete clinical measures at baseline, 8 weeks, and 16 weeks.
Group II: Care-as-UsualActive Control1 Intervention
The control group will receive care-as-usual, remaining on the waitlist for the regular TTP R&R groups. Participants in the CUC group will be asked to complete clinical measures at time points corresponding to the ITC group's baseline (prior to starting week one) and post-intervention (i.e. primary endpoint, end of week 8). Both groups will complete the clinical measures eight weeks later (16-week time point).

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Who is running the clinical trial?

Women's College HospitalLead Sponsor
102 Previous Clinical Trials
38,911 Total Patients Enrolled
Dana C. Ross, MD, MScPrincipal InvestigatorWomen's College Hospital

Media Library

The Trauma PORTAL Clinical Trial Eligibility Overview. Trial Name: NCT05670405 — N/A
Psychological Trauma Research Study Groups: Trauma PORTAL Intervention, Care-as-Usual
Psychological Trauma Clinical Trial 2023: The Trauma PORTAL Highlights & Side Effects. Trial Name: NCT05670405 — N/A
The Trauma PORTAL 2023 Treatment Timeline for Medical Study. Trial Name: NCT05670405 — N/A
~78 spots leftby Jun 2025
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