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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05726539
Other study ID # STUDY00003159
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 5, 2024
Est. completion date December 15, 2025

Study information

Verified date November 2023
Source University of Texas at Austin
Contact Elisa V Borah, PhD
Phone 5126398989
Email elisa.borah@austin.utexas.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will adapt and test an established peer support program for military spouses that offers them significant weekly group-based support on an array of topics that affect their lives. The curriculum will be able to be used in-person through group meetings or virtually by using a web-based meeting platform. The near-term impact of this study is that scientific knowledge will be developed about how well a curriculum-based, weekly, in-person support group for military spouses is effective in improving spouses' quality of life, mental health, social support and knowledge of health conditions impacting service members. This study will assess whether offering military spouses support for coping with their mental health and social support needs to achieve a greater quality of life, a greater sense of social support and knowledge about and access to resources to address a range of issues they may be facing throughout their spouses' military careers. By educating them about the health conditions their service members may experience and how to support their recovery and access to treatment, service members will also benefit by having more familial support for seeking treatment. Educating family members about the injuries that SMs face will help to maintain stronger family relationships and reduce family relationship stress.


Description:

This study will examine the impact of structured, evidence-based peer support group adapted to address the specific concerns of military spouses designed to increase social support, reduce depression and increase knowledge of SM health needs. Research Plan: This study will address Specific Aim 1:To adapt an existing veteran spouse peer support curriculum for active-duty spouses based on data collected from focus groups and interviews with military spouses, and Specific Aim 2: Conduct a randomized controlled trial (N = 150) to evaluate how military spouses' participation in a peer support group influences their mental health, quality of life and social support outcomes as well as improves their knowledge about psychological health problems faced by SMs and their confidence in supporting SM access to treatment. Hypothesis 1: Military spouses and significant others who participate in the Military Spouse Resiliency Group (M-SRG) program will show improved quality of life, sense of social support, self-care practices and depression symptoms.Hypothesis 2: After completing M-SRG participants will possess greater knowledge of common SM psychological health problems and greater confidence in how to support SMs' access to care.Impact: The near-term impact of this study and its products are that scientific knowledge will be developed about how well a curriculum-based, weekly, in-person support group for military spouses is effective in improving spouses' quality of life, mental health, social support and knowledge of health conditions impacting service members. The long-term impact of this study will be to offer ongoing, necessary health and social support to spouses through peer support groups. Equipping spouses with skills to address the mental health and healthcare needs of SMs will provide spouses necessary supports for their unique experiences as part of military life.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date December 15, 2025
Est. primary completion date December 5, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Participants must be married to or in a committed relationship with a service member stationed at Fort Hood; - Participants must have a reasonable expectation of remaining at Fort Hood for at least 4 months. - Participants must be willing to attend up to 10 sessions of a military spouse peer support group in person at Fort Hood. Exclusion Criteria: - Spouses who are separated or divorced from a service member are not eligible to participate.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Group-based peer support
Receipt of semi-structured curriculum based group peer support that addresses common concerns of military spouses

Locations

Country Name City State
United States University of Texas at Austin Austin Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

References & Publications (19)

Barlow JH, Turner AP, Wright CC. A randomized controlled study of the Arthritis Self-Management Programme in the UK. Health Educ Res. 2000 Dec;15(6):665-80. doi: 10.1093/her/15.6.665. — View Citation

Campbell SB, Renshaw KD. PTSD symptoms, disclosure, and relationship distress: explorations of mediation and associations over time. J Anxiety Disord. 2013 Jun;27(5):494-502. doi: 10.1016/j.janxdis.2013.06.007. Epub 2013 Jul 9. — View Citation

Donoho CJ, LeardMann C, O'Malley CA, Walter KH, Riviere LA, Curry JF, Adler AB. Depression among military spouses: Demographic, military, and service member psychological health risk factors. Depress Anxiety. 2018 Dec;35(12):1137-1144. doi: 10.1002/da.22820. Epub 2018 Aug 13. — View Citation

Eaton KM, Hoge CW, Messer SC, Whitt AA, Cabrera OA, McGurk D, Cox A, Castro CA. Prevalence of mental health problems, treatment need, and barriers to care among primary care-seeking spouses of military service members involved in Iraq and Afghanistan deployments. Mil Med. 2008 Nov;173(11):1051-6. doi: 10.7205/milmed.173.11.1051. — View Citation

Griffiths C, Motlib J, Azad A, Ramsay J, Eldridge S, Feder G, Khanam R, Munni R, Garrett M, Turner A, Barlow J. Randomised controlled trial of a lay-led self-management programme for Bangladeshi patients with chronic disease. Br J Gen Pract. 2005 Nov;55(520):831-7. — View Citation

Humphreys K, Wing S, McCarty D, Chappel J, Gallant L, Haberle B, Horvath AT, Kaskutas LA, Kirk T, Kivlahan D, Laudet A, McCrady BS, McLellan AT, Morgenstern J, Townsend M, Weiss R. Self-help organizations for alcohol and drug problems: toward evidence-based practice and policy. J Subst Abuse Treat. 2004 Apr;26(3):151-8; discussion 159-65. doi: 10.1016/S0740-5472(03)00212-5. — View Citation

Kees M, Rosenblum K. Evaluation of a psychological health and resilience intervention for military spouses: A pilot study. Psychol Serv. 2015 Aug;12(3):222-30. doi: 10.1037/ser0000035. — View Citation

Kennedy A, Reeves D, Bower P, Lee V, Middleton E, Richardson G, Gardner C, Gately C, Rogers A. The effectiveness and cost effectiveness of a national lay-led self care support programme for patients with long-term conditions: a pragmatic randomised controlled trial. J Epidemiol Community Health. 2007 Mar;61(3):254-61. doi: 10.1136/jech.2006.053538. — View Citation

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. — View Citation

Lester P, Peterson K, Reeves J, Knauss L, Glover D, Mogil C, Duan N, Saltzman W, Pynoos R, Wilt K, Beardslee W. The long war and parental combat deployment: effects on military children and at-home spouses. J Am Acad Child Adolesc Psychiatry. 2010 Apr;49(4):310-20. Erratum In: J Am Acad Child Adolesc Psychiatry. 2012 Mar;51(3):337. — View Citation

Long JA, Jahnle EC, Richardson DM, Loewenstein G, Volpp KG. Peer mentoring and financial incentives to improve glucose control in African American veterans: a randomized trial. Ann Intern Med. 2012 Mar 20;156(6):416-24. doi: 10.7326/0003-4819-156-6-201203200-00004. — View Citation

Mailey EL, Mershon C, Joyce J, Irwin BC. "Everything else comes first": a mixed-methods analysis of barriers to health behaviors among military spouses. BMC Public Health. 2018 Aug 15;18(1):1013. doi: 10.1186/s12889-018-5938-z. — View Citation

Pfeiffer PN, Heisler M, Piette JD, Rogers MA, Valenstein M. Efficacy of peer support interventions for depression: a meta-analysis. Gen Hosp Psychiatry. 2011 Jan-Feb;33(1):29-36. doi: 10.1016/j.genhosppsych.2010.10.002. Epub 2010 Nov 13. — View Citation

Pflieger JC, LeardMann CA, McMaster HS, Donoho CJ, Riviere LA; Millennium Cohort Family Study Team. The Impact of Military and Nonmilitary Experiences on Marriage: Examining the Military Spouse's Perspective. J Trauma Stress. 2018 Oct;31(5):719-729. doi: 10.1002/jts.22321. Epub 2018 Oct 19. Erratum In: J Trauma Stress. 2018 Dec;31(6):943-945. — View Citation

Schulz U, Pischke CR, Weidner G, Daubenmier J, Elliot-Eller M, Scherwitz L, Bullinger M, Ornish D. Social support group attendance is related to blood pressure, health behaviours, and quality of life in the Multicenter Lifestyle Demonstration Project. Psychol Health Med. 2008 Aug;13(4):423-37. doi: 10.1080/13548500701660442. — View Citation

Solomon P. Peer support/peer provided services underlying processes, benefits, and critical ingredients. Psychiatr Rehabil J. 2004 Spring;27(4):392-401. doi: 10.2975/27.2004.392.401. — View Citation

Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. — View Citation

Steenkamp MM, Corry NH, Qian M, Li M, McMaster HS, Fairbank JA, Stander VA, Hollahan L, Marmar CR. Prevalence of psychiatric morbidity in United States military spouses: The Millennium Cohort Family Study. Depress Anxiety. 2018 Sep;35(9):815-829. doi: 10.1002/da.22768. Epub 2018 May 10. — View Citation

Stevanovic D. Quality of Life Enjoyment and Satisfaction Questionnaire-short form for quality of life assessments in clinical practice: a psychometric study. J Psychiatr Ment Health Nurs. 2011 Oct;18(8):744-50. doi: 10.1111/j.1365-2850.2011.01735.x. Epub 2011 May 5. — View Citation

* Note: There are 19 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of Life Enjoyment and Satisfaction Questionnaire (Short Form) (Q-LES-Q-SF) The Quality of Life Enjoyment and Satisfaction Questionnaire measures satisfaction and enjoyment in different areas of daily functioning. Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Short Form) (Q-LES-Q-SF) from baseline, 2-weeks, 3 months
Primary Patient Health Questionnaire-9 The Patient Health Questionnaire-9 measures symptoms of depression. Change in Patient Health Questionnaire-9 from baseline, 2-weeks, and 3-months
Primary Military Spouse Self-Care Inventory (MSSCI) The Military Spouse Self-Care Inventory assesses five domains of self-care that military spouses regularly practice. Change in Military Spouse Self-Care Inventory from baseline, 2-weeks, and 3-months
Primary Interpersonal Support Evaluation List-12 (ISEL-12) The Interpersonal Support Evaluation List-12 is used to measure perceived social support. It has been widely used (Donoho et al., 2017) as a short-form measure of the traditional ISEL, which measures perceived social support (Cohen et al., 1985). Change in Interpersonal Support Evaluation List-12 from baseline, 2-weeks, and 3-months
Primary Psychological Health Knowledge Assessment Investigator-developed assessment of common psychological health concerns and available treatments commonly affecting service members Change in Psychological Health Knowledge Assessment from baseline, 2-weeks, and 3-months
Primary General Anxiety Disorder-7 (GAD-7) General Anxiety Disorder-7 is a valid and reliable instrument to measure generalized anxiety (Spitzer et al., 2006). Minimum is 0 and maximum is 21 and higher scores indicate more severe anxiety. Change in General Anxiety Disorder-7 from baseline, 2-weeks, and 3-months
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