跳至主要内容
临床试验/NCT02571478
NCT02571478已完成不适用

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

Wright State University4 个研究点 分布在 1 个国家目标入组 488 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
488
试验地点
4
主要终点
Responsive Attention Scale (RAS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Responsive Attention Scale (RAS)

时间窗: 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.

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

时间窗: 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.

Couples Satisfaction Index (CSI)

时间窗: 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.

Communication Skills Test

时间窗: 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).

Partner Compassion Scale

时间窗: 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.

Center for Epidemiological Studies Depression Scale - Short

时间窗: 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).

The Intimate Safety Questionnaire (ISQ)

时间窗: 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).

次要结局

  • 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.)
  • Home-Work Stress Spillover(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.)
  • Reasons For Seeking Marriage Checkup (RFSMC)(Participants will complete this measure at study enrollment.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Jeffrey A. Cigrang

Dr. Jeffrey A. Cigrang

Wright State University

研究点 (4)

Loading locations...

相似试验