Clinical trial NCT02571478: Evaluation of a Brief Marriage Intervention for Internal Behavioral Health Consultants in Military Primary Care
Official title: Evaluation of a Brief Marriage Intervention for Internal Behavioral Health Consultants in Military Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Marriage
Keywords: Military Couples
Marriage
Primary Care
Marriage Intervention
Air Force
Lead sponsor: Wright State University
Sponsor class: OTHER
Collaborators: name: Clark University
name: 59th Medical Wing
name: Malcolm Grow Medical Clinics and Surgery Center
name: 359th Medical Operations Squadron
First posted: 2015-10-08
Enrollment: 488
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The most challenging community problems faced by senior military leaders are closely linked to the quality of marriage relationships. These include family violence, spouse maltreatment, and suicide. Half (51%) of the service members who either completed or attempted suicide from 2008 to 2010 had a history of a failed intimate relationship, and for nearly one-third (30%) this failure had occurred within 30 days of the self-harm event. Relationship distress not only affects marriages but is also associated with depression, substance abuse, work role impairment and lowered children's health. Despite the potential high costs of chronic marital distress, very few couples seek therapy. In a recent Air Force study, only 6% of Airmen in distressed relationships reported making use of couple counseling after returning from deployment. Indeed, distressed couples wait an average of 6 years before seeking help, at which point their relationship likely has deteriorated dramatically.

Thus, there is a substantial need in the military for early detection and preventative care for deteriorating couples before serious and irreversible relationship damage has occurred. There are currently no widely available means to fill this need. Mild-to-moderately distressed couples may view therapy as reserved for only the most severely distressed couples, and thus delay seeking treatment until its efficacy is seriously diminished by the chronicity and severity of the accumulated relationship dysfunction.

The Marriage Checkup (MC) addresses this issue by providing a less-threatening option for couples to seek early preventative care before they have begun to identify as distressed. Intended to be the relationship health equivalent of the annual physical or dental checkup, the MC is a 4 to 5 hour assessment and feedback intervention. This brief intervention includes assessment of the couple's relationship history, strengths, and concerns and provides individualized feedback to the couple with a list of options addressing the couple's primary concerns. Studies conducted with civilian samples have shown that couples receiving MC demonstrate significant and lasting improvement across a range of marital health variables. In addition, MC has been shown to attract couples across the distress continuum and be perceived by couples as more accessible than traditional therapy.

In recognition of the limited reach and potential stigma of tertiary mental health treatment, the military services and the Department of Veterans Affairs have implemented collaborative care models in primary care. In a collaborative care model, mental health providers are embedded into the primary care setting and serve as integrated behavioral health consultants (IBHCs) to the medical providers. The IBHC provides brief, focused assessments and interventions for patients referred by their primary care provider. Marital problems are a common reason for primary care providers to refer patients to IBHCs, yet there has been no effort toward development of marital interventions suitable for primary care. MC's design as a brief "check-up" model for marriage help appeared particularly well-suited to primary care. Therefore, the investigators conducted a pilot study to adapt MC for use with military couples in Air Force primary care clinics (FWR20120054H).

In our pilot study the original MC was adapted for military couples and fit into the fast-paced environment of primary care. Military specific content for the assessment tools in the Marriage Checkup were developed. In addition, the team developed and piloted a protocol to use when only one member of the couple is available to come in for a Marriage Checkup, given the likelihood that some partners seeking an MC may have a partner who is currently deployed or otherwise unable/unwilling to participate in an in-person checkup. Finally, the Marriage Checkup was streamlined to fit within a Primary Care setting. More specifically, it was re-formatted into three 30-minute sessions. Session 1 consisted of the couple's relationship history and each partner's primary strengths, Session 2 focused on each partner's primary concern, and Session 3 is dedicated to feedback for the couple. IBHCs working in primary care were then trained to offer the intervention within a quasi-experimental research design in which pre-post changes were evaluated within subjects.

To date, twenty-two couples and one individual (N = 45; at least one partner in each couple was active duty) at two primary care sites have completed the MC. A multilevel modeling analysis indicated statistically significant pre-post changes for all study variables at both two weeks and two months, with effect sizes in the moderate range. Relationship satisfaction (B = .54, p = .003, B = .55, p = .004), distress (B = .75, p \< .001, B = .58, p = .003) and intimacy (B = .43, p \< .017, B = .47, p = .014) were significantly improved. In addition, couples completed a questionnaire measuring their level of satisfaction with the MC intervention itself. The scale ranged from 1(not at all) to 5 (very much), and across the questions the average response was 4.33 immediately post checkup and 4.05 at the one-month follow-up, indicating that couples were satisfied with their Marriage Checkup experience. The results of the pilot study provide preliminary evidence suggesting that the MC can be effectively adapted to a military population, and successfully used by behavioral health consultants (BHCs) working in an integrated primary care clinic.

The overall purpose of the proposed study is to build on pilot study findings by conducting a randomized trial of the military-adapted Marriage Checkup (MC) delivered in primary care by Integrated Behavioral Health Consultants (IBHCs). The primary outcomes of interest are marriage health (e.g., greater satisfaction, deeper intimacy) and community reach (e.g., attracts couples at-risk for marital deterioration who otherwise would not be seeking treatment). There are three specific objectives of the study, the first being to conduct a randomized trial comparing MC for use in military primary care clinics to a wait list control condition. Second, examine the effects of MC participation on relationship health at one month and six months post-treatment follow-up. Lastly, to determine whether the MC is successful at reaching couples at risk for marital deterioration who would otherwise be unlikely to seek traditional couple counseling.

This study will investigate two research hypotheses. The first hypothesis being that Military couples who participate in the Marriage Checkup (MC) for primary care will demonstrate positive relationship health trajectories for intimacy, acceptance, and relationship satisfaction over the course of six months when compared to couples in a wait-list control condition. A randomized control trial with 215 civilian couples demonstrated significant increases in relationship satisfaction, intimacy, and acceptance both in the short term and at two-year follow-up for treatment couples compared to no-treatment control couples. Emerging evidence further suggests that the primary mediator of improvements in marital health is the effect of the MC on increasing the level of intimate connection between spouses. In addition, the MC worked to affect both distal (i.e., depression) and specific (i.e., time together, sexual satisfaction and communication) outcomes. The second hypothesis is that the MC will attract military couples at-risk for marital deterioration who are otherwise not seeking relationship treatment. The MC is designed to significantly lower the barriers to couple help seeking. The MC is very brief and is advertised as an informational marital health service rather than therapy, intended for all couples who are interested in learning more about their strengths and areas of concern. The MC has been shown to attract a broad range of couples across the range of satisfaction from relationally satisfied to severely distressed and has been shown to successfully attract couples who would not otherwise seek any kind of relationship intervention.

The randomized trial will be conducted at four military primary care clinics. Three sites will be Wilford Hall Ambulatory Services Center (WHASC) in San Antonio, Texas, 359th Medical Operations Squadron (359 MDOS) in San Antonio, Texas, and Malcolm Grow Medical Clinics and Surgery Center (MGMCSC), Joint Base Andrews, in Maryland. The remaining site will be recommended by the Air Force Chief of Behavioral Health Optimization (co-investigator Maj Liz Najera).

Individuals and couples who express an interest in participating in the study will be scheduled by the on-site study coordinator with the IBHC to receive a more thorough explanation of the study purpose and requirements of participation. Potential participants will have the opportunity to ask questions about the study prior to making a decision to participate. Potential participants will be told that the MC involves three appointments with the IBHC within a four week period and completion of take-home relationship questionnaires to aid the BHC in assessing their relationship. At the third IBHC appointment the participants will receive feedback on the clinical questionnaires and interview results and be given a list of possible strategies for improving their relationship that has been tailored to their unique situation. For the purposes of the research, potential participants will be informed that they will be contacted approximately one month and six months later and asked to log onto a study website to re-complete surveys about their relationship. They will also complete surveys that ask their opinion of the MC including what they thought was most helpful and how it could be improved further.

This first contact will also include the standard brief clinical screening conducted by the IBHC for all referrals. During this screening the IBHC will also assess for the presence of any study exclusion factors. If at the conclusion of this first IBHC contact the potential participant expresses interest in participating and meets the inclusion and exclusion criteria, they will then meet with the Research Assistant to review and complete the informed consent documents for study participation and the baseline questionnaires.

The study will use a randomized two-group research design in which participants are randomly assigned after signing the informed consent document to either receive the MC right away or be placed on a 7-month wait list condition. All participants will complete study measures at baseline, eight weeks (1 month post-treatment for those assigned first to the MC condition) and 28 weeks (six months post-treatment for those assigned first to the MC condition). Participants assigned to the 7-month wait-list condition will be offered the MC at the completion of the 6-month follow-up measures.

Eligibility 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.

Primary outcomes:
measure: The Intimate Safety Questionnaire (ISQ) change from before MC and after MC
timeFrame: 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.
measure: Responsive Attention Scale (RAS)
timeFrame: 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.
measure: Partner Compassion Scale
timeFrame: 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.
measure: Communication Skills Test
timeFrame: 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.
measure: Center for Epidemiological Studies Depression Scale - Short
timeFrame: 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.
measure: Couples Satisfaction Index (CSI)
timeFrame: 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.
measure: The Intimate Safety Questionnaire (ISQ)
timeFrame: 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:
measure: Reasons For Seeking Marriage Checkup (RFSMC)
timeFrame: Participants will complete this measure at study enrollment.
measure: Marriage Checkup Evaluation- Couple (MC Eval) change from immediately after MC and one month after MC
timeFrame: Immediately after completion of the three Marriage Checkup appointments, and at a one-month post-treatment follow-up period.
measure: Seeking Marriage Counseling Questionnaire
timeFrame: Immediately after completion of the three Marriage Checkup appointments, and at a one-month post-treatment follow-up period.
measure: Home-Work Stress Spillover
timeFrame: Immediately after completion of the three Marriage Checkup appointments, and at a one-month post-treatment follow-up period.
Other outcomes:
Locations:
city: Fairborn
country: United States
facility: Wright-Patterson Air Force Base
state: Ohio
city: San Antonio
country: United States
facility: Wilford Hall Ambulatory Surgical Center
state: Texas
Study officials:
affiliation: Wright State University
name: Jeffrey A Cigrang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.