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: 9379807
• 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/9379807
• 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; DSM-V; Data; Diagnosis; Diagnostic; Ensure; Evaluation; Evidence based treatment; Feedback; Generations; Goals; Health; Health behavior; Healthcare; 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; Phonation; 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 disturbances; Sleeplessness; Smoking; Stimulus; Suggestion; Suicide; 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; mobile application; preference; primary care setting; primary outcome; psychosocial; public health relevance; secondary outcome; sleep onset; 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）： 我们提出了一个随机对照试验，以电话为基础，在初级保健短暂的失眠治疗，以实现改善部署后的伊拉克和阿富汗退伍军人谁符合失眠症的标准的心理社会功能的目标。该试验的主要结局将是心理社会功能，失眠严重程度作为次要结局。其他目标包括评估治疗收益的持久性，并从参与者那里获得有关拟议失眠治疗的实用性和可行性的反馈。 100名患有肌肉紧张症的伊拉克和阿富汗退伍军人将被随机分配到肌肉紧张症的简短行为治疗（BBTI;一次60分钟和一次30分钟的面对面接触，以及两次20分钟的电话接触）或渐进式肌肉放松训练对照组（通过两次面对面和两次电话会议进行手动放松训练，与BBTI条件相匹配治疗时间）。在随机化之前，受试者将在基线（和治疗后）完成临床医生管理的心理健康诊断访谈。将在基线（治疗前）、治疗中期、治疗后和6个月随访时（仅活性治疗组）完成心理社会功能、失眠严重程度和其他相关自我报告指标。睡眠参数（例如，睡眠日记，休息活动）将用睡眠日记移动的应用和Basis腕带（BasisScienceInc.，San弗朗西斯科）和相关的移动的应用程序，该应用程序跟踪睡眠周期以及睡眠和清醒运动，这将为每个参与者提供。将在基线和治疗后（仅活性治疗组在6个月随访时）收集一周的睡眠参数数据。两组还将在为期四周的干预期间收集睡眠参数数据。 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。接受BBTI的退伍军人将完成一份反馈问卷，询问治疗的各个方面。我们的目标是75%的退伍军人将报告说，治疗是可行的，并在各个领域可接受的，作为衡量的评级为三个或更高的五点李克特量表。完成BBTI的退伍军人还将被要求参加一个30分钟的反馈面试，审查每个领域的评分，以及治疗的最大和最小帮助方面，数据将被录音和编码。这些对退伍军人的治疗后采访将产生关于如何最好地改善伊拉克和阿富汗退伍军人的治疗并在初级保健环境中实施的建议。受过培训的编码员将被要求对退伍军人确定为有帮助的领域和需要改进的领域进行分类，直到没有新的类别被确定为止（例如，主题饱和度）。这些建议将被系统化，并用于准备在初级保健中实施伊拉克和阿富汗退伍军人的治疗。这项试验将提供有关康复结果的有用信息，并将产生具体的信息，使我们能够修改BBTI，确保根据退伍军人的反馈量身定制的产品。