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Family Psychoeducation for Military Veterans: A Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04180293
Recruitment Status : Not yet recruiting
First Posted : November 27, 2019
Last Update Posted : July 15, 2020
Sponsor:
Collaborator:
Mount Saint Vincent University
Information provided by (Responsible Party):
Abraham Rudnick, Nova Scotia Health Authority

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, 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 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.


Condition or disease Intervention/treatment Phase
Veterans Family Military Family Trauma, Psychological Behavioral: Pilot psychoeducation program Other: Program evaluation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Family Psychoeducation for Military Veterans: A Pilot Study
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Arm Intervention/treatment
Military Veterans and their families
This group will participate in both the pilot psychoeducation program and its evaluation.
Behavioral: Pilot psychoeducation program
Canadian Armed Forces veterans and their family members will be recruited to participate in this pilot psychoeducation program and its evaluation. Two six-week sessions will be implemented an OSI Clinic in Atlantic Canada - the first in January/February of 2020 and the second in the spring of 2020. 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 at the OSI clinic 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.).

Other: Program evaluation
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.




Primary Outcome Measures :
  1. Patient and family-perceived efficacy and utility of a pilot psychoeducation program. [ Time Frame: Final Interviews to occur 6 weeks after completion of 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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Canadian Armed Forces (CAF) veterans who wish to participate in this study must be:

    1. Living with a diagnosed Operational Stress Injury (OSI) for at least one year prior to the start of the study.
    2. Receiving care at the OSI Clinic in Dartmouth.
  • Family members who wish to participate may include:

    1. Spouses/partners;
    2. Siblings;
    3. Parents;
    4. Adult children (older than 19 years of age).

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04180293


Contacts
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Contact: Deborah A. Norris, PhD 902-457-6376 Deborah.Norris@msvu.ca
Contact: Abraham Rudnick, MD 902-460-6225 Abraham.Rudnick@nshealth.ca

Sponsors and Collaborators
Nova Scotia Health Authority
Mount Saint Vincent University
Investigators
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Principal Investigator: Deborah A. Norris, PhD Mount Saint Vincent University
Publications:
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
Bronfenbrenner, U. (1977). Toward an experimental ecology of human development. American Psychologist, 32(7), 513-531. doi.10.1037/0003-066X.32.7.51
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
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.
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
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.
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.
Marshall, C., & Rossman, G. B. (2016). Designing qualitative research (Sixth ed.). Los Angeles, California: Sage.
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
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
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
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.
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
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
Strauss, A. L., & Corbin, J. M. (1990). Basics of qualitative research: grounded theory procedures and techniques. Newbury Park, Calif: Sage.
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.
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

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Responsible Party: Abraham Rudnick, Clinical Director, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT04180293    
Other Study ID Numbers: 18200
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abraham Rudnick, Nova Scotia Health Authority:
Military
Veteran
Family
Psychoeducation
Resiliency
Operational stress injuries
Post traumatic stress disorder
Additional relevant MeSH terms:
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Psychological Trauma
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders