NCT04180293

Brief Summary

Operational Stress Injuries (OSIs), including post traumatic stress disorder (PTSD), are prevalent among veterans deployed in recent combat missions, the effects of which are experienced within their families. The development of evidence-based programs for veterans with OSIs and their families is critical because family functioning both affects and is affected by OSIs. Few programs have been implemented, however, particularly in Canada, and those that have are not evaluated. Research suggests that brief, systems-focused family psychoeducation programs are useful in the treatment of OSIs, specifically PTSD, leading to increases in targeted PTSD knowledge and skills and enhancing resilience. The purpose of this pilot study is to: (1) develop a systems-focused, virtual psychoeducational program designed to enhance resilience in veterans with OSIs receiving clinical care at an OSI clinic in Atlantic Canada and their families; (2) to implement the virtual program with veterans and their families at the OSI clinic; (3) to evaluate the efficacy of the program; and (4) to compare resilience-building family psychoeducation to the standard information-providing services currently available to families at the OSI clinic. Results will be shared within the network of OSI clinics in Canada and will inform the development of a proposal for a mixed-method study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 27, 2019

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 18, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2021

Enrollment Period

4 months

First QC Date

November 13, 2019

Last Update Submit

July 30, 2021

Conditions

Keywords

MilitaryVeteranFamilyPsychoeducationResiliencyOperational stress injuriesPost traumatic stress disorder

Outcome Measures

Primary Outcomes (1)

  • Patient and family-perceived efficacy and utility of a pilot psychoeducation program.

    Research suggests that brief, systems-focused family psychoeducation programs are useful in the treatment of Operational Stress Injuries (OSIs), specifically traumatic stress disorder (PTSD), leading to increases in targeted PTSD knowledge and skills and enhancing resilience. The purpose of this pilot study is to evaluate the perceived efficacy and utility of a pilot family psychoeducation program developed and implemented in collaboration with researchers at the Nova Scotia Health Authority (NSHA) and Mount St. Vincent University (MSVU). Using an ecological family systems theoretical framework, researchers will conduct individual semi-structured interviews with participants (based on a de novo interview guide) before, upon completion of the program, and 6 weeks after program completion to qualitatively analyze the data.

    Final Interviews to occur 6 weeks after completion of psychoeducation program.

Study Arms (1)

Military Veterans and their families

OTHER

This group will participate in both the pilot psychoeducation program and its evaluation.

Behavioral: Pilot psychoeducation programOther: Program evaluation

Interventions

Canadian Armed Forces veterans and their family members will be recruited to participate in this pilot virtual psychoeducation program and its evaluation. Two six-week sessions will be implemented over a virtual care platform (Zoom for healthcare) based out of OSI Clinic in Atlantic Canada - the first in January/February of 2021 and the second in the spring of 2021. A maximum of 10-15 participants (including both veterans and their family members) will be recruited for each group. Family members are defined as spouses/partners, siblings, parents, and adult children. Each of the weekly sessions will take place virtually and will be led by at least two trained facilitators (one from the research team, and one member of the OSI clinical staff team). Each of these sessions will focus on providing education of different topics relevant to those accessing services at the clinic (e.g., types of treatments available, tools to support families, self care, etc.).

Military Veterans and their families

At the end of each six-week session, program outcomes will be assessed qualitatively by a member of the research team. Participants will take part in semi-structured interviews guided by questions informed by the ecological family systems theory.

Military Veterans and their families

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Canadian Armed Forces (CAF) veterans who wish to participate in this study must be:
  • Living with a diagnosed Operational Stress Injury (OSI) for at least one year prior to the start of the study.
  • Receiving care at the OSI Clinic in Dartmouth.
  • Family members who wish to participate may include:
  • Spouses/partners;
  • Siblings;
  • Parents;
  • Adult children (older than 19 years of age).

You may not qualify if:

  • Active serving members of the CAF.
  • Active and former members of the Royal Canadian Mounted Police.
  • Children (younger than 19 years of age).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Scotia OSI Clinic

Dartmouth, Nova Scotia, B3B 1Y6, Canada

Location

Related Publications (21)

  • Armour C, Contractor A, Elhai JD, Stringer M, Lyle G, Forbes D, Richardson JD. Identifying latent profiles of posttraumatic stress and major depression symptoms in Canadian veterans: Exploring differences across profiles in health related functioning. Psychiatry Res. 2015 Jul 30;228(1):1-7. doi: 10.1016/j.psychres.2015.03.011. Epub 2015 Apr 22.

    PMID: 25936834BACKGROUND
  • Bowen, G. L., & Martin, J. A. (2011). The resiliency model of role performance for service members, veterans, and their families: A focus on social connections and individual assets. Journal of Human Behavior in the Social Environment, 21(2), 162-178. doi:101080/10911359.2011.546198

    BACKGROUND
  • Bronfenbrenner, U. (1977). Toward an experimental ecology of human development. American Psychologist, 32(7), 513-531. doi.10.1037/0003-066X.32.7.51

    BACKGROUND
  • Bronfenbrenner, U., & Morris, P. A. (1998). The ecology of developmental processes. In W. Damon & R. M. Lerner (Eds.), Handbook of child psychology: Theoretical models of human development (pp. 993-1028). Hoboken, NJ: John Wiley & Sons Inc

    BACKGROUND
  • Cramm, H., Norris, D., Smith-Evans, K., Hill, S., & Mahar, A. (2018). Military families and resiliency: Final report. Ottawa, ON: Canadian Forces Morale and Welfare Services.

    BACKGROUND
  • Fischer, E.P., Sherman, M.D., Han, X, & Owen, R.R. (2013). Outcomes of participation in the REACH multifamily group program for veterans with PTSD and their families. Professional Psychology, 44(3), 127-134. doi:10.1037/a0032024

    BACKGROUND
  • Karney, B., & Crown, J. (2007). Families under stress: An assessment of data, theory, and research on marriage and divorce in the military. Washington, DC: National Defense Research Institute.

    BACKGROUND
  • Lepore, S. J., & Revenson, T. A. (2006). Resilience and posttraumatic growth: Recovery, resistance, and reconfiguration. In L. G. Calhoun & R. G. Tedeschi (Eds.), Handbook of posttraumatic growth: Research and practice (pp. 24-46). New York: Psychology Press.

    BACKGROUND
  • Marshall, C., & Rossman, G. B. (2016). Designing qualitative research (Sixth ed.). Los Angeles, California: Sage.

    BACKGROUND
  • Masten AS. Global perspectives on resilience in children and youth. Child Dev. 2014 Jan-Feb;85(1):6-20. doi: 10.1111/cdev.12205. Epub 2013 Dec 16.

    PMID: 24341286BACKGROUND
  • Monk, J.K., Ruhlman, L.M., Nelson Goff, B.S., & Ogolsky, B.G. (2018). Brief-systemic programs for promoting mental health and relationship functioning in military couples and families. Journal of Family Theory and Review, 10(3), 566-586. doi:10.1111/jftr.12280

    BACKGROUND
  • National Defense and The Canadian Armed Forces Ombudsman (2013). On the homefront: assessing the wellbeing of Canada's military families in the new millennium. Available from: http://www.ombudsman. forces.gc.ca/en/ombudsman-reports-stats-investigations-military-families/military-families-index.page

    BACKGROUND
  • Norris, D., Cramm, H., Eichler, M., Tam-Seto, L., & Smith-Evans, K. (2015). Operational stress injury: The impact on family mental health and well-being: A report to Veterans Affairs Canada. Retrieved from https://cimvhr.ca/documents/Appendix%20B.pdf?cimlang=e

    BACKGROUND
  • Norris, D., Cramm, H., Schwartz, K. D., Tam-Seto, L., Mahar, A. L., Eichler, M., Blackburn, D. (2018). Qualitative study on the health and well-being of families of Canadian Armed Forces veterans with mental health problems: A report to Veteran's Affairs Canada. Charlottetown, Prince Edward Island: Veterans Affairs Canada.

    BACKGROUND
  • Richardson JD, Contractor AA, Armour C, St Cyr K, Elhai JD, Sareen J. Predictors of long-term treatment outcome in combat and peacekeeping veterans with military-related PTSD. J Clin Psychiatry. 2014 Nov;75(11):e1299-305. doi: 10.4088/JCP.13m08796.

    PMID: 25470095BACKGROUND
  • Richardson JD, St Cyr KC, McIntyre-Smith AM, Haslam D, Elhai JD, Sareen J. Examining the association between psychiatric illness and suicidal ideation in a sample of treatment-seeking Canadian peacekeeping and combat veterans with posttraumatic stress disorder PTSD. Can J Psychiatry. 2012 Aug;57(8):496-504. doi: 10.1177/070674371205700808.

    PMID: 22854032BACKGROUND
  • Rosa, E. M. & Tudge, J. (2013). Urie Bronfenbrenner's theory of human development: Its evolution from ecology to bioecology. Journal of Family Theory and Review, 5, 243-258. doi:10.1111/jftr.12022

    BACKGROUND
  • Rutter, M. (1999). Resilience concepts and findings: Implications for family therapy. Journal of Family Therapy, 21(2), 119-144. doi:10.1111/1467-6427.00108

    BACKGROUND
  • Strauss, A. L., & Corbin, J. M. (1990). Basics of qualitative research: grounded theory procedures and techniques. Newbury Park, Calif: Sage.

    BACKGROUND
  • Thompson, J. M., Van Til, L. D., Poirier, A., Sweet, J., McKinnon, K., Sudom, K., & Pedlar, D. (2014). Health and well-being of Canadian Armed Forces Veterans: Findings from the 2013 life after service survey. Charlottetown, Prince Edward Island: Veterans Affairs Canada.

    BACKGROUND
  • Walsh, F. (2002). A family resilience framework: Innovative practice applications. Family Relations, 51(2), 30-137. doi:10.1111/j.1741-3729.2002.00130.x

    BACKGROUND

MeSH Terms

Conditions

Psychological TraumaStress Disorders, Post-Traumatic

Interventions

Program Evaluation

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Evaluation Studies as TopicInvestigative TechniquesQuality of Health CareHealth Services AdministrationHealth Care Evaluation MechanismsHealth Care Quality, Access, and Evaluation

Study Officials

  • Deborah A. Norris, PhD

    Mount Saint Vincent University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Director

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 27, 2019

Study Start

January 18, 2021

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

August 2, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations