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Evaluation of a Brief Marriage Intervention for Internal Behavioral Health Consultants in Military Primary Care

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ClinicalTrials.gov Identifier: NCT02571478
Recruitment Status : Recruiting
First Posted : October 8, 2015
Last Update Posted : October 4, 2018
Sponsor:
Collaborators:
Clark University
Wilford Hall Medical Center
Malcolm Grow Medical Clinics and Surgery Center
359th Medical Operations Squadron
Information provided by (Responsible Party):
Dr. Jeffrey A. Cigrang, Wright State University

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.

Condition or disease Intervention/treatment Phase
Marriage Behavioral: Marriage Checkup Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Brief Marriage Intervention for Internal Behavioral Health Consultants in Military Primary Care
Study Start Date : February 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
Experimental: 7-Month Wait List Group
Couples will be randomly assigned to a wait list group. This group will wait seven months before starting The Marriage Checkup.
Behavioral: Marriage Checkup
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.

Experimental: MC Right Away
Couples will be randomly assigned to receive The Marriage Checkup right away.
Behavioral: Marriage Checkup
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.




Primary Outcome Measures :
  1. The Intimate Safety Questionnaire (ISQ) change from before MC and after MC [ Time Frame: 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 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.

  2. Responsive Attention Scale (RAS) [ Time Frame: 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; 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.

  3. Partner Compassion Scale [ Time Frame: 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 (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.

  4. Communication Skills Test [ Time Frame: 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 (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).

  5. Center for Epidemiological Studies Depression Scale - Short [ Time Frame: 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 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).

  6. Couples Satisfaction Index (CSI) [ Time Frame: 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; 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.

  7. The Intimate Safety Questionnaire (ISQ) [ Time Frame: 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 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).


Secondary Outcome Measures :
  1. Reasons For Seeking Marriage Checkup (RFSMC) [ Time Frame: Participants will complete this measure at study enrollment. ]
    The RFSMC is a 2-item measure asking participants why would like to get a MC and how they hope to benefit from a MC.

  2. Marriage Checkup Evaluation- Couple (MC Eval) change from immediately after MC and one month after MC [ Time Frame: Immediately after completion of the three Marriage Checkup appointments, and at a one-month post-treatment follow-up period. ]
    The MC Eval is an 8-item measure assessing the couple's satisfaction with their Marriage Checkup. Sample items on the MC Eval include: do you feel your Marriage Checkup was helpful, do you feel the Marriage Checkup captured your relationship overall, and would you recommend the Marriage Checkup to other couples. Scores range from 1 (not at all) to 5 (very much) with higher scores indicating greater satisfaction with the Marriage Checkup.

  3. Seeking Marriage Counseling Questionnaire [ Time Frame: Immediately after completion of the three Marriage Checkup appointments, and at a one-month post-treatment follow-up period. ]
    The Seeking Marriage Counseling Questionnaire is a 2-item measure at Baseline and a 2-item measure at Followup designed to assess if the couple has ever seeked marriage counseling and if they sought marriage counseling upon completing the MC. Items on the Seeking Marriage Counseling Questionnaire include: if The Marriage Checkup was not available to you in primary care, would you have sought marriage counseling services from somewhere else, have you ever sought any type of marriage counseling for your current relationship before, and have you sought any type of marriage counseling since completing your Marriage Checkup? Scores range from definitely not to definitely and include qualitative responses.

  4. Home-Work Stress Spillover [ Time Frame: Immediately after completion of the three Marriage Checkup appointments, and at a one-month post-treatment follow-up period. ]
    The Home-Work Stress Spillover is a 12-item measure of the amount to which partners feel their relationship stress impacts their work functioning. Sample items on the Home-Work Stress Spillover include: caused you to feel drained of energy needed for your work, caused you to make mistakes at work, and reduced your overall job performance. Score range from never to several times per week. The spillover scale was developed by Dilworth (2004) for a study of dual-career mothers and fathers. Internal consistency of the items used in the Dolworth (2004) study was good (Cronbach's alpha = .77).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Exclusion criteria will mirror clinical practice for patients normally not seen in primary care behavioral health, i.e., patients greater than mild risk for self-harm, patients with current alcohol dependence, psychotic disorder, significant dissociative disorder, or moderate or severe brain injury. Civilians along with potential participants that cannot understand, speak or read English will be excluded.

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): NCT02571478


Contacts
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Contact: Jeffrey A Cigrang, Ph.D, ABPP 937-775-4334 jeffrey.cigrang@wright.edu
Contact: Capt. Abby D Fields, USAF, BSC 210-292-1159 abby.fields@us.af.mil

Locations
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United States, Ohio
Wright-Patterson Air Force Base Recruiting
Fairborn, Ohio, United States, 45433
Contact: Ray Martorano, Ph.D.         
United States, Texas
Wilford Hall Ambulatory Surgical Center Recruiting
San Antonio, Texas, United States, 78236
Contact: Abby D Fields, PhD    210-554-1159    abby.fields@us.af.mil   
Sponsors and Collaborators
Wright State University
Clark University
Wilford Hall Medical Center
Malcolm Grow Medical Clinics and Surgery Center
359th Medical Operations Squadron
Investigators
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Principal Investigator: Jeffrey A Cigrang, Ph.D. Wright State University

Publications:
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.
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.
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.
Gray, T.D, Hawrilenko, M.J., & Cordova, J.V. (in progress). Distal and Specific Outcomes of the Marriage Checkup.
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.
Kindt, M. (2009). Talking paper on 2008 AF suicide trends. Unpublished manuscript, AF Medical Operations Agency.
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.

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Responsible Party: Dr. Jeffrey A. Cigrang, Wright State University
ClinicalTrials.gov Identifier: NCT02571478     History of Changes
Other Study ID Numbers: FWH20150096H
W81XWH-15-2-0025 ( Other Grant/Funding Number: USA Med Research ACQ Activity )
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018

Keywords provided by Dr. Jeffrey A. Cigrang, Wright State University:
Military Couples
Marriage
Primary Care
Marriage Intervention
Air Force