NCT05726539

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 2, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
12 months until next milestone

Study Start

First participant enrolled

February 5, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

1.8 years

First QC Date

January 2, 2023

Last Update Submit

November 29, 2023

Conditions

Keywords

military spousepeer supportquality of lifesocial support

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Intervention

ACTIVE COMPARATOR

participants receive group-based peer support

Behavioral: Group-based peer support

Waitlist

NO INTERVENTION

participants wait to receive peer support until pre and post assessments are complete with their matched intervention group

Interventions

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

Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Spouses who are separated or divorced from a service member are not eligible to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78701, United States

Location

Related 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.

    PMID: 11142075BACKGROUND
  • 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.

    PMID: 23917126BACKGROUND
  • 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.

    PMID: 30103266BACKGROUND
  • 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.

    PMID: 19055177BACKGROUND
  • 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.

    PMID: 16281998BACKGROUND
  • 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.

    PMID: 15063905BACKGROUND
  • 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.

    PMID: 26213791BACKGROUND
  • 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.

    PMID: 17325405BACKGROUND
  • 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.

    PMID: 11556941BACKGROUND
  • 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.

    PMID: 20410724BACKGROUND
  • 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.

    PMID: 22431674BACKGROUND
  • 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.

    PMID: 30111307BACKGROUND
  • 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.

    PMID: 21353125BACKGROUND
  • 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.

    PMID: 30338551BACKGROUND
  • 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.

    PMID: 18825581BACKGROUND
  • 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.

    PMID: 15222150BACKGROUND
  • 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.

    PMID: 16717171BACKGROUND
  • 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.

    PMID: 29745445BACKGROUND
  • 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.

    PMID: 21896118BACKGROUND

Study Officials

  • Elisa Borah, PhD

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2023

First Posted

February 14, 2023

Study Start

February 5, 2024

Primary Completion

December 5, 2025

Study Completion

December 15, 2025

Last Updated

December 1, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations