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Phase 3: iCBT + Treatment As Usual for Post-Traumatic Stress Disorder

N/A
Recruiting
Led By Nazanin Alavi
Research Sponsored by Dr. Nazanin Alavi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 2, 4, 6, 8, 10, 12, 6-month follow-up, 12-month follow-up
Awards & highlights

Study Summary

This trial aims to study the efficacy of using an innovative online platform to deliver cognitive behavioural therapy to correctional workers in order to address mental health problems.

Who is the study for?
This trial is for English-speaking correctional workers or public safety personnel diagnosed with Major Depressive Disorder, Generalized Anxiety Disorder, or PTSD. Participants must have reliable internet access and be able to consent. It excludes those with active suicidal thoughts, severe substance abuse, manic episodes, or psychosis.Check my eligibility
What is being tested?
The study tests the effectiveness of online cognitive behavioural therapy (iCBT) versus in-person CBT for mental health issues among correctional officers. The goal is to see if iCBT can reduce stigma and provide flexible access to treatment due to their irregular work hours.See study design
What are the potential side effects?
While not typical with CBT, potential side effects may include discomfort discussing personal issues, emotional distress from confronting difficult situations during therapy sessions, and temporary increases in anxiety or depression symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 2, 4, 6, 8, 10, 12, 6-month follow-up, 12-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 2, 4, 6, 8, 10, 12, 6-month follow-up, 12-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anxiety
Change in Symptoms (Generalized Anxiety Disorder - GAD 7)
Change in Symptoms (PTSD Checklist - PCL-5)
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Phase 4: iCBT + Treatment as UsualExperimental Treatment1 Intervention
Participants will be randomly assigned to this group and take part in the iCBT module program from phase 3.
Group II: Phase 3: iCBT + Treatment As UsualExperimental Treatment1 Intervention
CWs in the iCBT group, will be assigned to one the six therapy modules, based on their gender and diagnosis (i.e. Female/Male * GAD, MDD or PTSD). Each CW will be assigned a specific clinician (a trained psychiatrist/psychologist/ social worker) who would be their care liaison through the study. Each week, the clinician would send one session of the 12-session curriculum to the CW on a pre-determined day of the week. Each weekly session consists of 20-30 slides followed by a homework assignment. It usually takes 40-60 minutes for a participant to complete one weekly session which they have to complete by a specific day of the week. The clinician will review the CW's assignments and provide feedback on their performance. The clinician feedback is structured and takes approximately 15 minutes to complete. The clinician will then send the content for the next session along with the feedback.
Group III: Phase 4: In-Person CBT + Treatment as UsualActive Control1 Intervention
Participants will be randomly assigned to this group and complete in-person CBT with similar content, homework, and feedback as in the iCBT + TAU group. All in-person CBT will be delivered by a trained professional and each session will take approximately 60-75 minutes.
Group IV: Phase 3: Treatment as UsualActive Control1 Intervention
Participants will complete clincally validated questionnaires to measure symptoms while continuing with their regular daily activities and treatments (if any) (i.e., exercise, diet, medications, etc.)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
iCBT
2014
N/A
~310

Find a Location

Who is running the clinical trial?

Dr. Nazanin AlaviLead Sponsor
12 Previous Clinical Trials
1,016 Total Patients Enrolled
Queen's UniversityLead Sponsor
369 Previous Clinical Trials
121,465 Total Patients Enrolled
Online PsychoTherapy ClinicOTHER
8 Previous Clinical Trials
601 Total Patients Enrolled
~2 spots leftby Jul 2024
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