このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Adjunctive Brief Behavioral Treatment of Insomnia (BBTI) for Sleep Intervention (SI)

2017年3月17日 更新者:VA Office of Research and Development

An Adjunctive Behavioral Sleep Intervention to Prevent Veteran Suicides

There is a strong association between sleep disturbance and suicidal thoughts and behaviors. Sleep disturbance is also highly comorbid with other common conditions associated with suicide such as depression and posttraumatic stress disorder. Accordingly, this application focuses on improving sleep as a novel suicide prevention strategy that can be delivered to a broad range of Veterans. This pilot proposal specifically examines how Cognitive Behavioral Therapy for Insomnia, an efficacious treatment for insomnia, may reduce suicidal ideation in Veterans who also suffer from additional conditions. The proposal further suggests that adding this sleep intervention to usual care may further enhance overall care by increasing the utilization of recommended treatments for depression and posttraumatic stress disorder.

調査の概要

詳細な説明

Anticipated Benefit to VA Healthcare The proposed study will establish proof of concept that suicidal ideation can be reduced by adjunctively treating insomnia, a common problem that is both a risk factor for suicide and highly prevalent in common conditions associated with suicide such as depression and PTSD. In addition, to the extent that insomnia is improved, the investigators expect to both enhance Veteran's quality of life and increase their engagement with treatments for co-occurring conditions.

Project Background Suicide is the tenth leading cause of death in the U.S., is a major concern of the Department of Veterans Affairs (VA), and occurs at elevated rates among Veterans. Veterans with common chronic conditions such as PTSD, depression, substance abuse and chronic pain are at increased risk for suicide. Although evidence-based treatments exist for these conditions, a significant number of Veterans do not engage in or complete such treatments. This application focuses on an intervention target that co-occurs in each of the listed conditions at high rates and is itself an independent risk factor for suicidal thoughts and behaviors: the sleep disturbance of insomnia. Therefore, this proposal examines the use of cognitive-behavioral therapy for insomnia (CBT-I), an efficacious intervention that targets insomnia, as a novel way to reduce suicidal ideation in at-risk Veterans. Importantly, CBT-I has been successfully used in patients with PTSD and depression. Preliminary evidence from an uncontrolled trial in civilians suggests that CBT-I may also decrease suicidal ideation, but this has not been tested in Veterans, in the context of treatments for co-occurring conditions, or in a controlled trial.

Project Objectives The ultimate goal of the broader program of research is to reduce suicide among Veterans, while the proposed pilot project will provide data to guide the development of a larger trial. The primary objectives of this pilot project are to test whether using CBT-I as an adjunctive treatment: (1) is feasible to deliver in the context of other ongoing care and acceptable to participants; (2) can reduce the severity of suicidal ideation among Veterans at risk for suicide; and (3) can increase rates of engagement in treatments that address the co-morbid conditions that also put them at risk for suicide. The latter objective will help refine the study methods, design, and intervention in anticipation of a larger trial.

Project Methods In order to achieve these proof-of-concept objectives the investigators will conduct a small randomized clinical trial. Veterans who are either flagged as high risk for suicide or who have depression or PTSD will be recruited from VA sites only. Approximately 56 such Veterans who also endorse current suicidal ideation and current insomnia will be randomized to receive either treatment-as-usual or a 4-session CBT-I treatment in addition to treatment-as-usual. All participants will be encouraged to continue or to seek treatment for co-occurring conditions as recommended by their VA treatment providers. Assessments of suicidal ideation, insomnia, depression, PTSD, and quality of life will be conducted at baseline and following the treatment period. In addition, the investigators will collect provider and participant feedback at an exit interview immediately following the post-treatment assessment. The investigators will use multiple linear and logistic regression models to assess the effect of treatment on outcome measures across the study assessment time points.

研究の種類

介入

入学 (実際)

54

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • New York
      • Syracuse、New York、アメリカ、13210
        • Syracuse VA Medical Center, Syracuse, NY

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~70年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • English speaking male and female Veterans ages 18-70;
  • demonstrate an understanding of the informed consent;
  • seeking or receiving services at the Canandaigua VA Medical Center (VAMC) or Rochester Outpatient Clinic;
  • endorse death/suicidal ideation on the Columbia Suicide Severity Rating Scale
  • either (i) a current diagnosis in their medical record of Major Depressive Disorder, Depression not otherwise specified, PTSD,or (ii) evidence of current depression as indicated by a score of > 10 on the Patient Health Questionnaire (PHQ-9) or current PTSD as indicated by a score of > 38 on the PTSD Symptom Checklist (PCL-5)();
  • have an Insomnia Severity Index score > 10 indicating clinically meaningful insomnia with at least 1 insomnia-related daytime consequence (score of 1 on item #3) and trouble sleeping 3 months

Exclusion Criteria:

  • history of serious mental illness such as schizophrenia, Bipolar I or II disorder, or current psychiatric conditions such as psychosis, mania, dementia, cognitive impairment, OR suicidal ideation with plan and intent, a report of a suicide attempt in the past 6 months in the Computerized Patient Record System (CPRS) or via self-report, or a score of 4 on the Columbia-Suicide Severity Rating Scale
  • currently engaged in inpatient or partial hospitalization programs or ongoing/pending medical procedures that could inhibit sleep
  • recent substance dependence disorder with < 3 months in remission or abstinence;
  • suspicion of or evidence of untreated sleep apnea.
  • Diagnosis of a circadian rhythm disorder
  • Diagnosis of Narcolepsy
  • History of Seizures

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:ヘルスサービス研究
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的:CBT-I + TAU
Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).
Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.
Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.
アクティブコンパレータ:TAU
Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.
Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Columbia Suicide Severity Rating Scale (C-SSRS)
時間枠:post-treatment (~6-8 weeks)
The entire Columbia Suicide Severity Rating Scale (C-SSRS) will be administered, but the investigators will use its' Suicidal Ideation Intensity scale (0-25 score range summed from five items, with higher scores indicating more severe suicidal ideation) as the primary outcome.
post-treatment (~6-8 weeks)

二次結果の測定

結果測定
メジャーの説明
時間枠
Perceived Treatment Beliefs (PTS)
時間枠:post-treatment (~6-8 weeks)
A 21-item measure (with items ranging from 1-7) based on the theory of planned behavior and designed to assess beliefs about treatment and plans to engage in treatment in military populations. This measure will focus on engagement in PTSD and depression treatments. The total score has a range of 21-147 with higher scores indicating higher likelihood of engaging in care.
post-treatment (~6-8 weeks)
Patient Health Questionnaire-9 (PHQ-9)
時間枠:post-treatment (~6-8 weeks)
A well-validated 9-item self-report measure developed to assess depression severity; higher scores are associated with greater severity (range of 0-27 with higher scores indicating more severe depression severity).
post-treatment (~6-8 weeks)
Insomnia Severity Index (ISI)
時間枠:post-treatment (~6-8 weeks)
A well-validated 7-item self-report measure developed to assess insomnia severity; higher scores are associated with greater severity (range of 0-28 with higher scores indicating greater insomnia severity).
post-treatment (~6-8 weeks)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Wilfred R Pigeon, PhD、Syracuse VA Medical Center, Syracuse, NY

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2015年2月1日

一次修了 (実際)

2016年1月1日

研究の完了 (実際)

2016年1月1日

試験登録日

最初に提出

2014年9月22日

QC基準を満たした最初の提出物

2014年9月22日

最初の投稿 (見積もり)

2014年9月25日

学習記録の更新

投稿された最後の更新 (実際)

2017年4月28日

QC基準を満たした最後の更新が送信されました

2017年3月17日

最終確認日

2017年3月1日

詳しくは

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する