Telephone-Facilitated Insomnia Treatment in Primary Care for OEF/OIF/OND Veterans

OEF/OIF/OND 退伍军人初级保健中的电话辅助失眠治疗

• 批准号: 8983263
• 负责人: Shira Maguen
• 金额: --
• 依托单位: VETERANS AFFAIRS MED CTR SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-10-01 至 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8983263
• 关键词: Activities of Daily Living; Address; Afghanistan; Aftercare; Alcohol consumption; Area; Arousal; Attention Concentration; Behavior Therapy; Behavioral; Caring; Categories; Clinic; Code; Cognitive Therapy; Control Groups; Data; Diagnosis; Diagnostic; Diagnostic and Statistical Manual of Mental Disorders; Ensure; Evaluation; Evidence based treatment; Feedback; Generations; Goals; Health; Health behavior; Hour; Hygiene; Intervention; Interview; Iraq; Measurement; Measures; Mental Health; Methods; Military Personnel; Movement; Muscle relaxation phase; Occupational; Outcome; Paper; Participant; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Play; Primary Health Care; Productivity; Psyche structure; Quality of life; Questionnaires; Randomized; Randomized Controlled Trials; Rehabilitation therapy; Relaxation Therapy; Reporting; Research Personnel; Rest; Role; San Francisco; Science; Services; Severities; Short-Term Memory; Sleep; Sleep Wake Cycle; Sleep disturbances; Sleeplessness; Smoking; Stimulus; Suggestion; Target Populations; Telephone; Testing; Time; Training; Universities; Veterans; Visit; active method; base; care seeking; cognitive function; cohort; combat; comparison group; design; diaries; efficacy testing; emotion regulation; evidence base; executive function; follow-up; frontal lobe; functional outcomes; high risk; improved; improved functioning; indexing; meetings; mobile application; preference; primary care setting; primary outcome; psychosocial; public health relevance; secondary outcome; sleep onset; sleep regulation; social; treatment group

 DESCRIPTION (provided by applicant): We propose a randomized, controlled trial of a telephone-based, brief insomnia treatment in primary care in order to accomplish the goal of improving psychosocial functioning in post-deployment Iraq and Afghanistan Veterans who meet criteria for Insomnia Disorder. The primary outcome for the trial will be psychosocial functioning, with insomnia severity serving as the secondary outcome. Additional goals include evaluating durability of treatment gains and obtaining feedback from participants about the utility and feasibility of the proposed insomnia treatment. One hundred Iraq and Afghanistan Veterans with Insomnia Disorder will be randomly assigned to either Brief Behavioral Treatment for Insomnia (BBTI; one 60-minute and one 30-minute in-person encounter, and two 20-minute phone-based encounters) or a Progressive Muscle Relaxation Training control group (manualized relaxation training delivered by two in-person and two phone sessions, matched to the BBTI condition for therapist time). Prior to randomization, participants will complete clinician-administered, mental health diagnostic interviews at baseline (and post-treatment). Psychosocial functioning, insomnia severity, and other related self-report measures will be completed at baseline (pre-treatment), mid-treatment, post-treatment, and at 6-month follow-up (active treatment group only). Sleep parameters (e.g., sleep diaries, rest activity) will be completed with a sleep diary mobile application and the Basis wristband (Basis Science Inc., San Francisco) and associated mobile application that tracks sleep cycles and sleep and waking movement, which will be provided for each participant. One week of sleep parameters data will be collected at baseline as well as post-treatment (and at 6-month follow-up for active treatment group only). Both groups will also collect sleep parameters data during the four-week intervention period. We will conduct post-treatment evaluations with the experimental group to help determine the utility of BBTI as well as how the intervention may be improved for Iraq and Afghanistan Veterans. Veterans who received BBTI will complete a feedback questionnaire that will inquire about various aspects of the treatment. The goal is that 75% of Veterans will report that the treatment is feasible and acceptable in various domains, as measured by a rating of three or higher on a five-point Likert scale. Veterans who complete BBTI also will be asked to participate in a 30-minute feedback interview reviewing ratings of each of the domains, as well as most and least helpful aspects of the treatment, data which will be audio recorded and coded. These post- treatment interviews with Veterans will yield suggestions on how the treatment can best be improved for Iraq and Afghanistan Veterans and be implemented in primary care settings. Trained coders will be asked to categorize areas identified by Veterans as helpful and areas noted as needing improvement until no new categories are identified (e.g., thematic saturation). These suggestions will be systematized and used to prepare the treatment for implementation with Iraq and Afghanistan Veterans in primary care. This trial will provide useful information regarding rehabilitative outcomes, and it will yield specific information that will allow us to modify BBTI, ensuring a tailored product based on Veteran feedback.

 描述（由申请人提供）： 我们提出了一项基于电话的，简短的失眠治疗的随机对照试验，以实现改善伊拉克后伊拉克和阿富汗退伍军人的社会心理功能的目标，这些退伍军人符合失眠症标准。该试验的主要结果将是社会心理功能，失眠的严重程度作为次要结果。其他目标包括评估治疗的耐用性，并从参与者那里获得有关拟议失眠治疗的效用和可行性的反馈。 One hundred Iraq and Afghanistan Veterans with Insomnia Disorder will be randomly assigned to either Brief Behavioral Treatment for Insomnia (BBTI; one 60-minute and one 30-minute in-person encounter, and two 20-minute phone-based encounters) or a Progressive Muscle Relaxation Training control group (manualized relaxation training delivered by two in-person and Two phone sessions, matched to the BBTI condition for therapist 时间）。在随机化之前，参与者将在基线（和治疗后）完成临床管理的心理健康诊断访谈。在基线（治疗前），治疗，治疗后和6个月的随访（仅活跃治疗组）时，将完成社会心理功能，失眠严重程度和其他相关的自我报告措施。睡眠参数（例如，睡眠日记，休息活动）将通过睡眠日记移动应用程序和基础腕带（基础科学公司，旧金山）和相关的移动应用程序完成，该应用程序跟踪睡眠周期，睡眠和醒来运动，这将为每个参与提供。一周的睡眠参数数据将在基线和治疗后（仅在有效治疗组的6个月后续工作中收集）。两组还将在四周的干预期内收集睡眠参数数据。我们将与实验组进行治疗后评估，以帮助确定BBTI的效用以及如何改善伊拉克和阿富汗退伍军人的干预措施。接受BBTI的退伍军人将完成一份反馈问卷，这将需要有关治疗的各个方面。目的是，75％的退伍军人将报告该处理在各个领域都是可行的，并且可以接受，这是通过在五点李克特量表上的三个或更高的评级来衡量的。完成BBTI的退伍军人还将被要求参加30分钟的反馈访谈审查每个领域的评分，以及治疗的大多数和最大帮助的方面，这些数据将记录和编码。这些对退伍军人的治疗后访谈将提出有关如何最好地改善伊拉克和阿富汗退伍军人的治疗方法，并在初级保健环境中实施。训练有素的编码人员将被要求将退伍军人确定为有益的领域，并在没有确定新类别（例如主题满意度）之前被指出需要改进的领域。这些建议将被系统化，并用于准备与伊拉克和阿富汗退伍军人在初级保健中实施的治疗方法。该试验将提供有关康复结果的有用信息，它将产生特定的信息，使我们能够修改BBTI，并确保基于资深反馈的量身定制产品。