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临床试验/NCT05207436
NCT05207436已完成2 期

Pilot Test of Intranasal Oxytocin as an Enhancer of Brief Couples Therapy for PTSD

San Diego Veterans Healthcare System1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年1月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Couples Satisfaction Inventory-32

研究概览

简要总结

In 2019 VA mandated that all Veterans seeking mental health care have access to flexible family mental health services in VA (VHA directive 1163.04). This study aims to respond to this mandate by further improving an evidence-based PTSD treatment designed to decrease PTSD symptoms and improve relationship satisfaction for Veterans and their romantic partners. Brief Cognitive-Behavioral Conjoint Therapy (B-CBCT), an 8-session dyadic psychotherapy for PTSD, has been found to significantly reduce PTSD symptoms, but the effects of B-CBCT on relationship satisfaction are less reliable and robust. Pharmacological augmentation of psychotherapy utilizing intranasal oxytocin, a neurohormone that influences mechanisms of trauma recovery and social behavior, may help improve relationship satisfaction outcomes. If successful, the proposed study will advance knowledge of strategies for improving Veterans' quality of life by improving their intimate relationships along with PTSD symptoms.

详细描述

Military Veterans often experience challenges reintegrating into their communities after military service, due in part to mental health problems such as posttraumatic stress disorder (PTSD). PTSD, a psychiatric disorder that develops in response to exposure to traumatic events, disproportionately affects Veterans, leads to poorer physical health, and impairs psychosocial functioning and quality of life. Mitigating the negative effects of PTSD on Veterans' health, functioning, and well-being is therefore a major goal of the VA.

The premise that interpersonal relationships play a key role in resilience, risk, and recovery from trauma is supported by research showing a robust association between PTSD and social support. Treatment approaches that bolster Veterans' internal strengths and enhance the capacity of their social environments to provide support are most likely to have powerful effects on well-being.

Many Service Members and Veterans with PTSD experience impairment and distress within intimate relationships at greater levels than among civilian couples. Consistent with this, Veterans seeking treatment for PTSD often identify relationships as targets of intervention and express the desire to involve close others in treatment. The VA has been responsive to these needs, as shown by the continuum of services available to Veterans and their families through the VA Family Services program. The Veterans' Mental Health and Other Care Improvements Act of 2008 stated that marriage and family counseling were to be available to Veterans to facilitate their treatment and rehabilitation. In 2009, VA began an initiative to select evidence-based family therapies and train mental health providers in these treatments. More recently, Directive 1163.04 indicated that Veterans with a mental health diagnosis should be asked about their interest in having family involved in their care and be offered marital and family counseling. The VA Family Services program supports several treatment approaches to meet the diverse mental health needs of Veterans and their loved ones. One such option for Veterans who want to simultaneously improve their PTSD symptoms and their relationship functioning is Cognitive-Behavioral Conjoint Therapy (CBCT) for PTSD. The VA has been disseminating CBCT since 2013.

CBCT is a PTSD-specific cognitive-behavioral psychotherapy attended by the couple that uses close relationships as the vehicle for recovery. Across 15 75-minute sessions, this manualized therapy addresses the patient's PTSD and relationship functioning simultaneously via its focus on PTSD psychoeducation within relationship contexts, communication skills, behavioral approach exercises, and cognitive interventions. CBCT effectively treats PTSD, exhibiting large within-group effect sizes on clinician-rated PTSD symptoms.

Across studies, however, CBCT has had less robust, more variable effects on relationship satisfaction than on PTSD. This is likely because the factors governing relationship satisfaction are complex and rely on a number of independent, interpersonal factors. The largest published study of CBCT (N = 40 dyads), in which CBCT was compared to a waitlist control group, found a moderate within-group effect (g = 0.64) and between-group effect (g = 0.47) of CBCT on Veterans' relationship satisfaction. This sample, however, was composed of only about 25% Veterans. Given that Veteran couples are known to have lower relationship satisfaction than non-Veteran couples, it is important to further examine CBCT among Veteran couples that are more representative of couples seen in general VA practice to increase generalizability of findings. However, preliminary data from couples treated as part of VA's dissemination of CBCT suggest that effects on relationship satisfaction are noticeably smaller than in previous studies. This may be due, in part, to poor engagement in the intervention. Couples experience many logistical obstacles to engaging in care (e.g., the need to coordinate schedules, lack of childcare). Veterans with PTSD can encounter additional obstacles related to beliefs about mental health and mental health treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • One member of the couple be a Veteran enrolled in the San Diego VA Healthcare System with a Posttraumatic Stress Disorder Checklist-5 score of > 33, indicating a likely PTSD diagnosis.
  • Agree not to receive other individual or conjoint psychotherapy for PTSD during the treatment portion of the study
  • If already on psychoactive medication prior to study referral, Veteran participant must remain on a stable psychoactive medication regimen for at least 45 days.

排除标准

  • Acute suicidality
  • Psychosis
  • Active substance use disorder
  • Severe ongoing medical problems, including heart disease and neuroendocrinological disorders (e.g., diabetes)
  • Uncontrolled hypotension (systolic blood pressure <100 mm Hg) or hypertension (>160/100 mm Hg)
  • Pregnancy, delivery in the past 6 months, or current breastfeeding
  • Severe intimate aggression reported by either partner

研究组 & 干预措施

Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal Oxytocin

Experimental

Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (B-CBCT) weekly. Prior to each session, the Veteran participant will self-administer intranasal oxytocin. The estimated length of treatment participation is 8 to 15 weeks. All procedures take place in the Veterans home via home-based clinical video teleconferencing (CVT).

干预措施: Oxytocin nasal spray (Drug)

Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal Oxytocin

Experimental

Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (B-CBCT) weekly. Prior to each session, the Veteran participant will self-administer intranasal oxytocin. The estimated length of treatment participation is 8 to 15 weeks. All procedures take place in the Veterans home via home-based clinical video teleconferencing (CVT).

干预措施: Brief Cognitive-Behavioral Conjoint Therapy (Behavioral)

结局指标

主要结局

Couples Satisfaction Inventory-32

时间窗: three months post-treatment (approximately 5-months after baseline)

The Couples Satisfaction Index is a 32-item self-report survey assessing several domains of relationship satisfaction. Higher sum scores (range 0 to 161) represent higher relationship satisfaction.

次要结局

  • PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5)(baseline)
  • PTSD Checklist for DSM-5 (PCL-5)(three months post-treatment (approximately 5-months after baseline))
  • Brief Inventory of Psychosocial Functioning(three months post-treatment (approximately 5-months after baseline))

研究者

发起方
San Diego Veterans Healthcare System
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Dr. Leslie Morland

Director of Telemental Health, Staff Clinical Psychologist

San Diego Veterans Healthcare System

研究点 (1)

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