PTSDNCT05311696
Residential Retreat for Veterans and First-responders
An observational study of PTSD, run by Valhalla Project Niagara at 1 site in Canada.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD
- What is being tested?
- psychoeducation
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 27 Mar 2022to 21 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: These are individuals who are veterans of the military of first-responders, who have also been diagnosed with PTSD.
Who may be able to join
- Diagnosis of PTSD, being a military veteran or first-responder, awareness of treating physician about program attendance
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Valhalla Project Niagara
Niagara-on-the-Lake, Ontario, L0S 1J0
Graham Bettes, 289-2597758, grahambettes@hotmail.com
Pouria Saffaran, Bsc, 647-895-7474, pouria.saffaran@alum.utoronto.ca
About this study
Official title: 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
Read the 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.
- Conditions
- PTSD
- Being tested
- psychoeducation
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychoeducationOther
Also called demonstration of stress management techniques, social cohesion activities
The program consists of psychoeducational material regarding PTSD, demonstration of various stress management techniques, and social cohesion activities
| Study group | Role | What they receive |
|---|---|---|
| Residential Cohort | Those completing the program in a residential context Receives: Other: psychoeducation | |
| Online Cohort | Those completing the program online Receives: Other: psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-month after completion of the program
Drop-out rate in the Residential Program
Determining the extent of treatment drop-out in the Residential Program
Measured: 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.
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.
Measured: 1-month after completion of the program
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.
Measured: 1-month after the completion of the program
Drop-out rate in the Online Program
Determining the extent of treatment drop-out in the Online Program
Measured: at the end of the 2 month online program for the online cohort.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start27 Mar 2022 (estimated)
- Primary completion21 Nov 2022 (estimated)
- Study completion21 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valhalla Project Niagara
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaan Reitav, PhD, C.Psych, Principal investigator, Canadian Memorial Chiropractic College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311696
- Sponsor's protocol ID
- 2650
- Status last verified
- Mar 2022
- First submitted
- 3 Mar 2022
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified data may be available upon request by other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Efficacy and Feasibility of a Residential Retreat Program for PTSD in First-responders and Veterans: A Non-randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05311696
- Acronym / sponsor ID
- 2650
- Conditions
- PTSD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Valhalla Project NiagaraIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2022 (estimated)
- Primary completion
- 21 Nov 2022 (estimated)
- Study completion
- 21 Nov 2023 (estimated)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Residential Cohort | – | Other: psychoeducationThose completing the program in a residential context |
| Online Cohort | – | Other: psychoeducationThose completing the program online |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- These are individuals who are veterans of the military of first-responders, who have also been diagnosed with PTSD.
Key inclusion criteria (1 listed)
- Diagnosis of PTSD, being a military veteran or first-responder, awareness of treating physician about program attendance
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychoeducationAlso: demonstration of stress management techniques, social cohesion activitiesThe program consists of psychoeducational material regarding PTSD, demonstration of various stress management techniques, and social cohesion activities | Other | Online Cohort, Residential Cohort |
Primary outcome
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.
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
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.
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Individual participant dataSharing planned: Undecided. De-identified data may be available upon request by other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaan Reitav, PhD, C.Psych principal investigator
Canadian Memorial Chiropractic College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD, run by Valhalla Project Niagara at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pouria Saffaran, Bsc (647-895-7474, pouria.saffaran@alum.utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Management of PTSD Using the Perceived Medical Condition Self-Management Scale (time frame: 1-month after completion of the program). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.