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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05311696
Other study ID # 2650
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 27, 2022
Est. completion date November 21, 2023

Study information

Verified date March 2022
Source Valhalla Project Niagara
Contact Pouria Saffaran, Bsc
Phone 647-895-7474
Email pouria.saffaran@alum.utoronto.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date November 21, 2023
Est. primary completion date November 21, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of PTSD, being a military veteran or first-responder, awareness of treating physician about program attendance Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Other:
psychoeducation
The program consists of psychoeducational material regarding PTSD, demonstration of various stress management techniques, and social cohesion activities

Locations

Country Name City State
Canada Valhalla Project Niagara Niagara-on-the-lake Ontario

Sponsors (1)

Lead Sponsor Collaborator
Valhalla Project Niagara

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Symptom Management of PTSD Using the Perceived Medical Condition Self-Management Scale 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
Primary Drop-out rate in the Residential Program Determining the extent of treatment drop-out in the Residential Program at the end of the 5-day residential program for the residential cohort
Primary Symptoms of PTSD Indicated by the PTSD Checklist for DSM-5 scale. 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
Primary Interpersonal and Intrapersonal Functioning Using the Brief Inventory of Psychosocial Functioning (B-IPF) 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
Primary Drop-out rate in the Online Program Determining the extent of treatment drop-out in the Online Program at the end of the 2 month online program for the online cohort.
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