- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05311696
Residential Retreat for Veterans and First-responders
April 4, 2022 updated by: Valhalla Project Niagara
Examining the Efficacy and Feasibility of a Residential Retreat Program for PTSD in First-responders and Veterans: A Non-randomized Controlled Study
The purpose of this study is to determine the potential efficacy and feasibility of a residential retreat program to address PTSD symptoms in Veterans and First-responders
Study Overview
Detailed Description
After obtaining written consent, participants will complete their program as they had previously intended.
Each wave of the residential retreat program will last 5 days.
During the program, participants will complete the study questionnaires.
They will complete these questionnaires again 1 month after the completion of the program.
As a control, individuals completing the program in the online format will also be asked to provide written consent and will complete the questionnaires during the program and 1-month after its completion.
Study Type
Observational
Enrollment (Anticipated)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Pouria Saffaran, Bsc
- Phone Number: 647-895-7474
- Email: pouria.saffaran@alum.utoronto.ca
Study Locations
-
-
Ontario
-
Niagara-on-the-lake, Ontario, Canada, L0S 1J0
- Recruiting
- Valhalla Project Niagara
-
Contact:
- Pouria Saffaran, Bsc
- Phone Number: 647-895-7474
- Email: pouria.saffaran@alum.utoronto.ca
-
Contact:
- Graham Bettes
- Phone Number: 289-2597758
- Email: grahambettes@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
These are individuals who are veterans of the military of first-responders, who have also been diagnosed with PTSD.
Description
Inclusion Criteria:
- Diagnosis of PTSD, being a military veteran or first-responder, awareness of treating physician about program attendance
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Residential Cohort
Those completing the program in a residential context
|
The program consists of psychoeducational material regarding PTSD, demonstration of various stress management techniques, and social cohesion activities
Other Names:
|
|
Online Cohort
Those completing the program online
|
The program consists of psychoeducational material regarding PTSD, demonstration of various stress management techniques, and social cohesion activities
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symptom Management of PTSD Using the Perceived Medical Condition Self-Management Scale
Time Frame: 1-month after completion of the program
|
determining the potential efficacy of the residential program for improving symptom management.
The scale is adapted to reflect participants management of their PTSD symptoms.
Score ranges from 8 to 40.
Higher scores indicate better management.
|
1-month after completion of the program
|
|
Drop-out rate in the Residential Program
Time Frame: at the end of the 5-day residential program for the residential cohort
|
Determining the extent of treatment drop-out in the Residential Program
|
at the end of the 5-day residential program for the residential cohort
|
|
Symptoms of PTSD Indicated by the PTSD Checklist for DSM-5 scale.
Time Frame: 1-month after completion of the program
|
determining the potential efficacy of the residential program for improving PTSD symptoms.
Scores range from 0 to 80. Higher scores indicate more symptoms of PTSD.
|
1-month after completion of the program
|
|
Interpersonal and Intrapersonal Functioning Using the Brief Inventory of Psychosocial Functioning (B-IPF)
Time Frame: 1-month after the completion of the program
|
determining the potential efficacy of the residential program for improving interpersonal and intrapersonal functioning (e.g., relationship with family, ability to manage daily tasks, etc.).
Scores range from 0 to 42.
Higher scores indicate more problems and lower functioning.
|
1-month after the completion of the program
|
|
Drop-out rate in the Online Program
Time Frame: at the end of the 2 month online program for the online cohort.
|
Determining the extent of treatment drop-out in the Online Program
|
at the end of the 2 month online program for the online cohort.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jaan Reitav, PhD, C.Psych, Canadian Memorial Chiropractic College
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 27, 2022
Primary Completion (Anticipated)
November 21, 2022
Study Completion (Anticipated)
November 21, 2023
Study Registration Dates
First Submitted
March 3, 2022
First Submitted That Met QC Criteria
April 4, 2022
First Posted (Actual)
April 5, 2022
Study Record Updates
Last Update Posted (Actual)
April 5, 2022
Last Update Submitted That Met QC Criteria
April 4, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 2650
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
De-identified data may be available upon request by other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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