Brief Behavioral Insomnia Treatment Study (BBTI)
2020年1月28日 更新者：VA Office of Research and Development
Telephone-Facilitated Insomnia Treatment in Primary Care for OEF/OIF/OND Veterans
The purpose of this study is to determine whether a brief, behavioral treatment for insomnia is effective in addressing social and occupational functioning and overall health among Veterans with insomnia disorder.
調査の概要
詳細な説明
This study is 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 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.
研究の種類
介入
入学 (実際)
93
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
-
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California
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San Francisco、California、アメリカ、94121
- San Francisco VA Medical Center, San Francisco, CA
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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～75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:
- Veterans between the ages of 18-75 years.
- Meet DSM-5 Criteria for Insomnia Disorder.
- Able attend in-person appointments at the San Francisco VA Medical Center
The investigators will not exclude individuals who are taking insomnia or antidepressant medications, provided they have been stable on these medications for at least one month and still meet criteria for Insomnia Disorder as described above.
- Specifically, individuals receiving benzodiazepine or benzodiazepine receptor agonists, anticonvulsants, atypical antipsychotic medication, or non-SSRI antidepressant medications such as trazodone will not be excluded provided they meet the criteria described above.
The investigators will not exclude Veterans receiving any type of psychotherapy, provided they have received this treatment for at least three months and do not plan to discontinue this treatment during the BBTI trial.
- However, individual who need to start a new type of psychotherapy during the course of the treatment will be excluded, or they will need to wait three months in order to enroll in the trial.
- The investigators will not exclude individuals with TBI.
- The investigators will not exclude individuals with chronic pain.
- The investigators will not exclude individuals based on any other mental health condition, including posttraumatic stress disorder and depression.
Exclusion Criteria:
- Conditions that may be associated with comorbid insomnia, including a lifetime history of any psychiatric disorder with psychotic features or bipolar disorder, and alcohol or drug dependence within the past year.
- Individuals who meet criteria for alcohol or drug abuse will be asked to reduce alcohol to recommended limits during the course of the study and/or refrain from drug use in order to be included.
- Veterans with suicidal or homicidal ideation.
- Veterans who are pregnant, due to the biological impact of pregnancy on sleep.
- Veterans who work night or rotating shifts.
- Veterans with untreated moderate to severe sleep apnea (those receiving treatment will not be excluded from the study).
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Brief Behavioral Treatment for Insomnia
Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI).
BBTI consists of two in-person sessions, with the two other sessions conducted via telephone.
BBTI emphasizes behavioral elements of insomnia treatment.
Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles.
Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
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Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI).
BBTI consists of two in-person sessions, with the two other sessions conducted via telephone.
BBTI emphasizes behavioral elements of insomnia treatment.
Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles.
Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
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アクティブコンパレータ：Progressive Muscle Relaxation
Participants will receive 4 weeks of progressive muscle relaxation training (PMRT).
PMRT consists of two in-person and two phone sessions.
Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises.
Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.
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Participants will receive 4 weeks of progressive muscle relaxation training (PMRT).
PMRT consists of two in-person and two phone sessions.
Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises.
Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.
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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 |
|---|---|---|
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Work and Social Adjustment Scale (WSAS)
時間枠：Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate
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The WSAS assesses functioning at work, home, management, social leisure activities, private leisure activities, and relationships with others.
Scores range from 0-40, with higher scores meaning greater impairment.
The measure was administered at Baseline (week 0), Mid-treatment (week 3) & Post-treatment (week 5).
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Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate
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Work and Social Adjustment Scale (WSAS)
時間枠：Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only
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The WSAS assesses functioning at work, home, management, social leisure activities, private leisure activities, and relationships with others.
Scores range from 0-40, with higher scores meaning greater impairment.
The WSAS was administered at Follow-up (6 months Post-treatment) for participants receiving the experimental treatment only.
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Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Insomnia Severity (ISI)
時間枠：Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate
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The ISI is a specific index of perceived insomnia severity.
Areas assessed include problems with sleep onset, sleep maintenance, and early morning awakening; dissatisfaction with sleep; interference with daily functioning; impact on quality of life; and worry about sleep problems.
Scores range from 0-28, with higher scores meaning greater impairment.
The measure was administered at Baseline (week 0), Mid-treatment (week 3) & Post-treatment (week 5).
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Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate
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Insomnia Severity (ISI)
時間枠：Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only
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Insomnia Severity Index (ISI) is a specific index of perceived insomnia severity.
Areas assessed include problems with sleep onset, sleep maintenance, and early morning awakening; dissatisfaction with sleep; interference with daily functioning; impact on quality of life; and worry about sleep problems.
Scores range from 0-28, with higher scores meaning greater impairment.
The ISI was administered at Follow-up (6 months Post-treatment) for participants receiving the experimental treatment only.
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Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only
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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。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Ranney RM, Gloria R, Metzler TJ, Huggins J, Neylan TC, Maguen S. Brief behavioral treatment for insomnia decreases trauma-related nightmare frequency in veterans. J Clin Sleep Med. 2022 Jul 1;18(7):1831-1839. doi: 10.5664/jcsm.10002.
- Maguen S, Gloria R, Huggins J, Goldstein LA, Kanady JC, Straus LD, Metzler TJ, Lujan C, Neylan TC. Brief behavioral treatment for insomnia improves psychosocial functioning in veterans: results from a randomized controlled trial. Sleep. 2021 Mar 12;44(3):zsaa205. doi: 10.1093/sleep/zsaa205.
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 (実際)
2016年1月6日
一次修了 (実際)
2019年3月31日
研究の完了 (実際)
2019年6月30日
試験登録日
最初に提出
2015年10月2日
QC基準を満たした最初の提出物
2015年10月6日
最初の投稿 (見積もり)
2015年10月8日
学習記録の更新
投稿された最後の更新 (実際)
2020年2月7日
QC基準を満たした最後の更新が送信されました
2020年1月28日
最終確認日
2020年1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。