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临床试验/NCT06670794
NCT06670794尚未招募不适用

Using Ecological Momentary Data to Inform a Web Intervention for Romantic Partners Concerned About Their Loved Ones' Drinking

University of Florida0 个研究点目标入组 160 人开始时间: 2026年9月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
160
主要终点
CP Depression Symptoms Questionnaire

研究概览

简要总结

Aim 1. Couples (N=50 dyads) with a Concerned Partner (CP) and a Drinking Partner (DP) will independently complete baseline and follow-up surveys and a 21-day EMA with three daily reports on their communication and DP's drinking. Aim 2. Iteratively develop a four-session web based intervention and evaluate the WBI's feasibility and acceptability with 15 CPs. Aim 3. Perform a pilot randomized controlled trial (RCT) comparing WBI to psychoeducation control in 110 couples.

详细描述

Alcohol misuse negatively affects relationships and is significantly correlated with higher rates of relationship conflict, distress, and dissolution as well as other serious negative interpersonal consequences (e.g., domestic violence, sexual assaults). Encouragement from concerned partners (CPs) is a common motivator for those who misuse alcohol to pursue care and often the most helpful mechanism in supporting change. The goals of this proposal are to: Identify how specific CP behaviors influence their partner's alcohol craving, motives, drinking, and problems on a daily basis using dyadic ecological momentary assessment techniques (Aim 1); use the knowledge from EMA analysis to iteratively develop a CP-focused web-based intervention (WBI) that provides psychoeducation about communication patterns that influence DP drinking and by integrating personalized feedback about CPs' own communication behaviors that may be working against their goals (Aim 2); and pilot the WBI's efficacy on CP outcomes (depression, anxiety, social support), their partner's drinking behavior (alcohol consumption, motives, related consequences), and both partners' relationship distress and conflict (Aim 3). The investigators expect the WBI will yield significant improvements in all outcomes. This project is significant because intervening with CPs has strong potential to change relationship dynamics that may reduce problems and prevent future problems associated with alcohol misuse. It also develops a new prevention model that does not rely on the drinking partner attending a clinical facility to access care. The proposed study is innovative because it uses dyadic and ecological momentary assessment designs to test dynamic questions about interdependence in relationship interactions and alcohol use between partners and employs the generated knowledge to inform intervention adaptation. Teaching CPs to effectively communicate their concerns may be a necessary catalyst for decreasing their partner's alcohol use and preventing alcohol use disorders. The potential reach of this intervention is large such that it can be easily implemented over the web to those who may need help but would not otherwise seek care.

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
Single (Participant)

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

  • CP Inclusion Criteria:
  • be at least 18 years old
  • be in a romantic relationship with their partner
  • be living with their partner,
  • have a computer, tablet, or mobile phone with Internet access
  • have no plans to separate from their partner in the next 60 days
  • indicate no concerns they would be physically hurt by their partner on the Intimate Partner Screen

排除标准

  • drinking scores at or above the threshold for DP participation
  • DP Inclusion Criteria:
  • be at least 18 years old
  • misuses alcohol as defined by their scores (4+ for women/non-gender confirming, 5+ for men) on the consumption portion of the Alcohol Use Disorder Identification Test (AUDIT-C) (Dawson et al., 2005)
  • has a computer, tablet, or mobile phone with Internet access
  • indicates no concerns they would be physically hurt by their partner
  • DP Exclusion Criteria:
  • current alcohol treatment
  • currently concerned about their partner's drinking

研究组 & 干预措施

Experimental web-based intervention

Experimental

CPs in the experimental web-based intervention condition will complete web-based sessions including personalized feedback and information about how communication and self-care affect their own well-being and their partner's alcohol use behaviors.

干预措施: Web-based intervention for concerned partners (Behavioral)

Psychoeducation control

Other

Psychoeducation control CPs will be routed to visit self-help resources on NIAAA's website ("Alcohol's Effects on Health") and asked to spend the same amount of time (20-30 minutes) reviewing site content.

干预措施: Psychoeducation control (Behavioral)

结局指标

主要结局

CP Depression Symptoms Questionnaire

时间窗: 1 month post-intervention.

Patient Health Questionnaire. 8 items. Scores range from 0-32. Higher scores indicate more depressive symptoms.

CP Anxiety Symptoms Questionnaire

时间窗: 1 month post-intervention.

Generalized Anxiety Disorder scale. 7 items. Higher scores indicate more anxiety symptoms.

CP Anger expression questionnaire

时间窗: 1 month post-intervention.

Dimensions of Anger Reactions - 5 item (DAR-5). Scores range 1-5 with higher scores indicating greater anger.

CP Loneliness Questionnaire

时间窗: 1 month post-intervention.

Measure: UCLA 3-item Loneliness Scale (Hughes, M. E., Waite, L. J., Hawkley, L. C., \& Cacioppo, J. T. (2004). A Short Scale for Measuring Loneliness in Large Surveys. Research on Aging, 26(6), 655-672. https://doi.org/10.1177/0164027504268574) Scores are 1-9. Higher scores indicate more loneliness.

CP Partner Social Support Questionnaire

时间窗: 1 month post-intervention.

Marital Perceived Social Support (Cohen et al., 1985). Scored 0-3. Higher scores mean more social support.

CP-DP Relationship Functioning Questionnaire

时间窗: 1 month post-intervention.

Quality of Marriage Index (Norton, 1983). Higher scores indicate greater relationship satisfaction.

DP AUDIT Questionnaire

时间窗: 1 month post-intervention.

Drinking Partner's AUDIT score. 10 items. Items are summed. Greater scores indicate greater alcohol use.

CP General Social Support Questionnaire

时间窗: 1 month post-intervention.

MOS Social Support Survey (Sherbourne \& Stewart, 1991). Scored 1-5. Higher scores indicate more social support. Sherbourne, C. D., \& Stewart, A. L. (1991). The MOS social support survey. Social science \& medicine, 32(6), 705-714.

DP Alcohol Use Questionnaire

时间窗: 1 month post-intervention.

Drinking Partner's: Alcohol consumption via the Quantity/Frequency/Peak Alcohol Use Index (Dimeff et al., 1991). Six items measure the drinking partner's alcohol consumption. The items are not scored together but evaluated individually (e.g., frequency, typical quantity, peak quantity, etc.). Higher scores denote greater consumption.

DP Drinking Motives Questionnaire

时间窗: 1 month post-intervention.

Drinking Partner's Drinking Motives using the Drinking Motives Questionnaire (Cooper et al., 1992). Subscales for coping, enhancement, social, and conformity. Items are averaged. Higher scores indicate greater endorsement of that motive.

DP Alcohol-related Consequences Questionnaire

时间窗: 1 month post-intervention.

Drinking Partner's Alcohol-related Consequences assess via the Brief Young Adult Alcohol Related Consequences measure. 24 items. Scores are created by summing the items. Higher scores denote greater consequences endorsed.

次要结局

  • CP-DP Communication Questionnaire(1 month post-intervention.)
  • CP-DP Perceived Partner Responsiveness Questionnaire(1 month post-intervention.)
  • CP Communication about Drinking Questionnaire(1 month post-intervention.)
  • CP-DP Communication: Number of conflicts(1 month post-intervention.)

研究者

申办方类型
Other
责任方
Sponsor

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