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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 2, 4, 6, 8, 10, 12, 6-month follow-up, 12-month follow-up

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

Do I qualify?Apply below to find out

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

365 Previous Clinical Trials

120,317 Total Patients Enrolled

Online PsychoTherapy ClinicOTHER

8 Previous Clinical Trials

601 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current opportunities for individuals to take part in this research?

"Results from clinicaltrials.gov demonstrate that this project, initially posted on July 1st 2020 and last updated on May 26th 2022 is no longer actively recruiting patients. However, 2210 other trials are currently seeking volunteers."

Answered by AI

To whom do the requirements of this clinical experiment apply?

"Those wishing to participate in this research should have a confirmed diagnosis of an anxiety disorder and be between the ages of 18-55. 100 individuals are needed for full enrollment."

Answered by AI