NCT02571478

Brief Summary

The psychological health of military members is a critical element of force health protection and readiness. Frequent deployments and high operations tempo at home strain the relationships and families of today's military more than ever before (e.g., Karney \& Crown, 2007). Since 2001 the likelihood of divorce in the Air Force increased with the number of days that Airmen were deployed (Karney \& Crown, 2007). Distressed relationships not only adversely affect members' adjustment and readiness (e.g., Hoge et al., 2006) but also are centrally implicated in suicides (i.e., relationship problems are the precipitating event in 51% of Air Force suicides, Kindt, 2009) and domestic violence (Pan, Neidig, \& O'Leary, 1994). Unfortunately, traditional sources of marriage counseling available to service members are largely underutilized. The MC brings a fresh perspective that helps normalize relationship help-seeking and in turn reach larger numbers of distressed couples early. The partnering of MC and integrated primary care appears to be an ideal combination of behavioral health innovations that has the potential to measurably enhance relationship health for the military services.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
488

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

October 4, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

4.5 years

First QC Date

October 4, 2015

Last Update Submit

August 24, 2021

Conditions

Keywords

Military CouplesMarriagePrimary CareMarriage InterventionAir Force

Outcome Measures

Primary Outcomes (7)

  • The Intimate Safety Questionnaire (ISQ) change from before MC and after MC

    The ISQ (Cordova, Gee \& Warren, 2005) is a 28-item measure of the degree to which partners feel safe being vulnerable with each other across several different domains of the relationship (Emotional Safety, Sexual Safety, Safety Disagreeing, Safety Being Yourself, and Safety in Public). Sample items include: I feel comfortable telling my partner when I'm feeling sad, sex with my partner makes me feel uncomfortable, and when I am with my partner I feel safe and comfortable. Scores range from 0 (never) to 4 (always). Negatively worded items are reversed scored such that higher scores indicate higher levels of intimacy.

    Participants will complete this measure at study enrollment, immediately after completion of the three Marriage Checkup appointments, and at a one-month post-treatment follow-up period.

  • Responsive Attention Scale (RAS)

    Responsive Attention Scale (RAS; Trillingsgaard, 2013) is a 12-item scale measuring partners' responses to various bids for attention. The scale was developed for the Danish application of the Marriage Checkup. Items are rated on a 1(very rarely) to 5(very often) likert scale. Sample items include "I receive a warm welcome from my partner when we meet at the end of the day," "my partner smiles or laughs if I try to show him/her something funny," and "my partner is present and attentive when we eat together." Internal reliability for this measure has been high, with aplhas of .81 for both men and women.

    Participants will complete this measure at study enrollment, immediately after completion of the three Marriage Checkup appointments, and at a one-month post-treatment follow-up period.

  • Partner Compassion Scale

    Partner Compassion Scale (PCS; Gray, Cordova \& Maher, 2015). The PCS is a 9-item scale of compassionate expressions demonstrated by partners. This measure was developed to measure the primary mechanism of compassionate understand within the Marriage Checkup. Items are rated on a 0 (never) to 4 (always) likert scale. Sample items include " when my partner sees that I am hurting, he/she tries to comfort me," "even when he/she is upset or angry, my partner tries to be careful with my feelings," and "even when we disagree, my partner can put him/herself in my shoes." Since this measure was designed for the current study, it has not yet been tested for consistency and reliability.

    Participants will complete this measure at study enrollment, immediately after completion of the three Marriage Checkup appointments, and at a one-month post-treatment follow-up period.

  • Communication Skills Test

    Communication Skills Test (CST; Saiz \& Jenkins, 1995). The CST is a 10-item scale measuring communication skills within intimate relationships. Items are rated on a 1(almost never) to 7 (almost always) likert scale. Sample items include "I interrupt my partner when we are arguing" and "when discussing issues, I summarize what my partner says in order to make sure I understand him/her. Studies support the general reliability and validity of this measure (Stanley et al., 2001; Stanley et al., 2005).

    Participants will complete this measure at study enrollment, immediately after completion of the three Marriage Checkup appointments, and at a one-month post-treatment follow-up period.

  • Center for Epidemiological Studies Depression Scale - Short

    Center for Epidemiologic Studies Depression Scale - Short (CES-D 10; adapted from Radloff 1977). The CES-D 10 is a shortened version of the CESD -20 and has demonstrated consistency and reliability consistent with the CESD-20 (Andresen, 1994). The CESD measures symptoms of depression within the previous week and uses a scale from Rarely or none of the time (less than one day) to All of the time (5-7 days). Sample items include "I felt lonely," "my sleep was restless," and "I felt like I could not 'get going.'" The CES-D has demonstrated good internal reliability and consistence (Cronbach's α = .88) (Thomas et al, 2008).

    Participants will complete this measure at study enrollment, immediately after completion of the three Marriage Checkup appointments, and at a one-month post-treatment follow-up period.

  • Couples Satisfaction Index (CSI)

    Couples Satisfaction Index (CSI; Funk \& Rogge, 2007). The CSI is a self-report questionnaire that assesses relationship satisfaction. Items include "please indicate the degree of happiness, all things considered, of your relationship" which is rated on a scale from 1 (extremely unhappy) to 6 (perfect) and "in general, how satisfied are you with your relationship?" which is rated on a scale from 0 (not at all) to 5 (completely). These four items have been selected from a larger pool of items which together contribute information to the construct of relationship satisfaction with arguably more precision than commonly used measures like the 32-item Dyadic Adjustment Scale (Spanier, 1976). The CSI has demonstrated excellent internal consistency, Cronbach's α equal to .94, and strong convergent validity with existing measures of relationship satisfaction by showing strong correlations with such measures, intercorrelations equal to .87 with the 32-item DAS and .91 with the 4-item DAS.

    Participants will complete this measure at study enrollment, immediately after completion of the three Marriage Checkup appointments, and at a one-month post-treatment follow-up period.

  • The Intimate Safety Questionnaire (ISQ)

    The ISQ (Cordova, Gee \& Warren,, 2005) is a 28-item measure of the degree to which partners feel safe being vulnerable with each other across several different domains of the relationship. Sample items include: I feel comfortable telling my partner when I'm feeling sad, sex with my partner makes me feel uncomfortable, and when I am with my partner I feel safe and comfortable. Scores range from 0 (never) to 4 (always). Negatively worded items are reversed scored such that higher scores indicate higher levels of intimacy. Internal reliability has been found to be adequate with alphas of .84 and .92 for men and women, respectively, and test-retest reliabilities of r = .89 and r = .91 for men and women, respectively. In the most recent MC study, internal reliability was high (Cronbach's α = 0.91) (Cordova et.al, in progress).

    Participants will complete this measure at study enrollment, immediately after completion of the three Marriage Checkup appointments, and at a one-month post-treatment follow-up period.

Secondary Outcomes (4)

  • Reasons For Seeking Marriage Checkup (RFSMC)

    Participants will complete this measure at study enrollment.

  • Marriage Checkup Evaluation- Couple (MC Eval) change from immediately after MC and one month after MC

    Immediately after completion of the three Marriage Checkup appointments, and at a one-month post-treatment follow-up period.

  • Seeking Marriage Counseling Questionnaire

    Immediately after completion of the three Marriage Checkup appointments, and at a one-month post-treatment follow-up period.

  • Home-Work Stress Spillover

    Immediately after completion of the three Marriage Checkup appointments, and at a one-month post-treatment follow-up period.

Study Arms (2)

7-Month Wait List Group

EXPERIMENTAL

Couples will be randomly assigned to a wait list group. This group will wait seven months before starting The Marriage Checkup.

Behavioral: Marriage Checkup

MC Right Away

EXPERIMENTAL

Couples will be randomly assigned to receive The Marriage Checkup right away.

Behavioral: Marriage Checkup

Interventions

The MC adapted for primary care consists of three 30-minute appointments with the IBHC. Session 1 consists of discussing the of the couple's relationship history and each partner's primary strengths. Session 2 focuses on each partner's primary concern about the relationship. Session 3 is dedicated to providing feedback for the couple that identifies strengths, areas for possible improvement, and a menu of possible strategies or resources for the couple to consider pursuing.

7-Month Wait List GroupMC Right Away

Eligibility Criteria

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

You may qualify if:

  • Potential participants will be active duty and/or their active duty or Department of Defense (DoD) beneficiary spouses (adults \>= 18 years old) who present to the IBHC in primary care with relationship concerns or questions following referral from their primary care manager or in response to study advertisements. Potential participants will be eligible for enrollment whether both partners are participating in-person or only one partner. Study participants do not have to be married; enrollment is open to active duty or who are not married but in committed romantic partnerships

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Wright-Patterson Air Force Base

Fairborn, Ohio, 45433, United States

Location

Wilford Hall Ambulatory Surgical Center

San Antonio, Texas, 78236, United States

Location

Related Publications (17)

  • Bush NE, Reger MA, Luxton DD, Skopp NA, Kinn J, Smolenski D, Gahm GA. Suicides and suicide attempts in the U.S. Military, 2008-2010. Suicide Life Threat Behav. 2013 Jun;43(3):262-73. doi: 10.1111/sltb.12012. Epub 2013 Jan 17.

    PMID: 23330611BACKGROUND
  • Cummings EM, Goeke-Morey MC, Papp LM. Children's responses to everyday marital conflict tactics in the home. Child Dev. 2003 Nov-Dec;74(6):1918-29. doi: 10.1046/j.1467-8624.2003.00646.x.

    PMID: 14669904BACKGROUND
  • Gottman, J. M. & Gottman, J.S. (1999). The marriage survival kit. In R. Berger & M.T. Hannah (Eds.), Preventative approaches in couples therapy (pp 304-330). Philadelphia, PA: Brunner/Mazel.

    BACKGROUND
  • Cordova, J. V., Scott, R. L., Dorian, M., Mirgain, S., Yaeger, D., & Groot, A. (2005). The marriage checkup: A motivational interviewing approach to the promotion of marital health with couples at-risk for relationship deterioration. Behavior Therapy, 36, 301-310.

    BACKGROUND
  • Cordova JV, Fleming CJ, Morrill MI, Hawrilenko M, Sollenberger JW, Harp AG, Gray TD, Darling EV, Blair JM, Meade AE, Wachs K. The Marriage Checkup: a randomized controlled trial of annual relationship health checkups. J Consult Clin Psychol. 2014 Aug;82(4):592-604. doi: 10.1037/a0037097. Epub 2014 Jun 16.

    PMID: 24932565BACKGROUND
  • Gee CB, Scott RL, Castellani AM, Cordova JV. Predicting 2-year marital satisfaction from partners' discussion of their marriage checkup. J Marital Fam Ther. 2002 Oct;28(4):399-407. doi: 10.1111/j.1752-0606.2002.tb00365.x.

    PMID: 12382549BACKGROUND
  • Morrill MI, Eubanks-Fleming C, Harp AG, Sollenberger JW, Darling EV, Cordova JV. The marriage checkup: increasing access to marital health care. Fam Process. 2011 Dec;50(4):471-85. doi: 10.1111/j.1545-5300.2011.01372.x.

    PMID: 22145720BACKGROUND
  • Maguen, S., Cohen, G., Cohen, B. E., Lawhon, G. D., Marmar, C. R., & Seal, K. H. (2010). The role of psychologists in the care of Iraq and Afghanistan veterans in primary care settings. Professional Psychology: Research and Practice, 41, 135-142.

    BACKGROUND
  • Gray, T.D, Hawrilenko, M.J., & Cordova, J.V. (in progress). Distal and Specific Outcomes of the Marriage Checkup.

    BACKGROUND
  • Karney, B. R., & Crown, J. S. (2007). Families under stress: An assessment of data, theory, and research on marriage and divorce in the military. Santa Monica, CA: RAND Corporation.

    BACKGROUND
  • Hoge CW, Auchterlonie JL, Milliken CS. Mental health problems, use of mental health services, and attrition from military service after returning from deployment to Iraq or Afghanistan. JAMA. 2006 Mar 1;295(9):1023-32. doi: 10.1001/jama.295.9.1023.

    PMID: 16507803BACKGROUND
  • Kindt, M. (2009). Talking paper on 2008 AF suicide trends. Unpublished manuscript, AF Medical Operations Agency.

    BACKGROUND
  • Pan HS, Neidig PH, O'Leary KD. Predicting mild and severe husband-to-wife physical aggression. J Consult Clin Psychol. 1994 Oct;62(5):975-81. doi: 10.1037//0022-006x.62.5.975.

    PMID: 7806729BACKGROUND
  • Whisman MA, Uebelacker LA. Impairment and distress associated with relationship discord in a national sample of married or cohabiting adults. J Fam Psychol. 2006 Sep;20(3):369-77. doi: 10.1037/0893-3200.20.3.369.

    PMID: 16937993BACKGROUND
  • Wilson, P. G. (2003). The Air Force experience: Integrating behavioral health providers into primary care. In R. G. Frank, S. H. McDaniel, J. H. Bray, & M. Heldring (Eds.), Primary care psychology, Washington DC: American Psychological Association.

    BACKGROUND
  • Seal KH, Cohen G, Bertenthal D, Cohen BE, Maguen S, Daley A. Reducing barriers to mental health and social services for Iraq and Afghanistan veterans: outcomes of an integrated primary care clinic. J Gen Intern Med. 2011 Oct;26(10):1160-7. doi: 10.1007/s11606-011-1746-1. Epub 2011 Jun 7.

    PMID: 21647750BACKGROUND
  • Cigrang JA, Cordova JV, Gray TD, Fedynich AL, Maher E, Diehl AN, Hawrilenko M. Marriage checkup in integrated primary care: A randomized controlled trial with active-duty military couples. J Consult Clin Psychol. 2022 May;90(5):381-391. doi: 10.1037/ccp0000734.

Study Officials

  • Jeffrey A Cigrang, Ph.D.

    Wright State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Jeffrey A. Cigrang

Study Record Dates

First Submitted

October 4, 2015

First Posted

October 8, 2015

Study Start

February 1, 2016

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

August 30, 2021

Record last verified: 2021-08

Locations