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Treatment of Insomnia and Depression in Elders (TIDE) (TIDE)

2015年11月30日 更新者:University of Alabama, Tuscaloosa

Insomnia and depression are two of the most prevalent mental health disorders and often co-occur.

Health disparities in rural America and among African-Americans are well documented. The investigators propose an R34 exploratory project to test the feasibility of delivering high-fidelity insomnia and depression psychological services to an underserved population. Treatment of Insomnia and Depression in Elders (TIDE) is a pilot study that will treat rural, predominantly African-American older adults who present to their primary care physician with co-occurring insomnia/depression. Stage 1 will be an uncontrolled case study series (n = 10) focusing on treatment development/refinement and patient acceptability. In stage 2, feasibility will be experimentally tested with 46 participants randomized to integrated cognitive-behavior therapy (CBT) + usual care or to usual care only in an effectiveness pilot study. The treatment will combine/integrate compact CBT for insomnia (including relaxation, sleep restriction, and stimulus control) and for depression (including cognitive therapy and behavioral activation). The experimental intervention comprises delivering CBT services by videoconferencing to patients in primary care settings who live in rural areas. Treatment will be evaluated by pre, post, and follow-up self report instruments on insomnia, depression, and quality of life. In addition, the stage 1 pilot will use investigator designed quantitative and qualitative measures to evaluate critical process variables including patient acceptability of the video format, patient acceptability of the treatments, and obstacles to adherence. Depending on stage 1 data, these measures may be incorporated into stage 2 as well. Several innovative features of this exploratory project include: intervening with CBT on both disorders hoping to gain a synergy by their combined presentation; use of telehealth to deliver treatment to distant locations; translation of efficacy findings to an effectiveness trial; treatment will be delivered in the primary care setting, the preferred locale of rural, older adults; the study will extend knowledge of the range of CBT applications by enrolling under-represented groups with respect to ethnicity, literacy, and financial resources.

The primary aims of this project are (1) to determine the feasibility and maximal therapy characteristics of integrated CBT for co-occurring insomnia/depression in both the case study series (stage 1) and the experimental investigation (stage 2), (2) collect pilot data on whether participants receiving integrated CBT + usual care show comparable or greater reductions in insomnia symptoms compared to participants receiving usual care at posttreatment and follow-up, and (3) collect pilot data on whether participants receiving integrated CBT + usual care show comparable or greater reductions in depression symptoms compared to participants receiving usual care at posttreatment and follow-up.

調査の概要

研究の種類

介入

入学 (予想される)

46

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

    • Alabama
      • Tuscaloosa、Alabama、アメリカ、35487
        • UATuscaloosa

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

50年~100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:

  • 50 years of age or older,
  • resident of the Black Belt or adjacent counties and receiving services from one of our primary care collaborators
  • absence of significant cognitive impairment as indicated by a score of 24 or higher (17 or higher for those with only an eighth grade education) on the Mini-Mental Status Examination (MMSE; Folstein, Folstein, & McHugh, 1975
  • not currently receiving psychological treatment,
  • absence of serious suicidality
  • concurrent psychiatric/medical disorders are not automatic disqualifiers unless they prevent participants from attending CBT therapy sessions or impede data collection,
  • a referral from their primary care physician indicating presence of both insomnia and depression symptoms of sufficient significance to warrant initiation or continuance of primary care treatment for newly emergent or residual symptoms. Persons who are currently receiving pharmacotherapy for insomnia and/or depression must evidence residual symptoms of both disorders of sufficient magnitude to be evaluated as clinically significant and warranting further treatment by their primary care physician.

Exclusion Criteria:

  • age is below 50
  • not receiving services from one of our primary care collaborators
  • significant cognitive impairment is present as indicated by a score of 23 or lower (16 or lower for those with only an eighth grade education) on the MMSE
  • currently receiving psychological treatment
  • presence of serious suicidality
  • intrusive and unstable concurrent psychiatric/medical disorders
  • primary care physician declines to refer

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:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:CBT
Cognitive behavior therapy for both insomnia and depression featuring stimulus control and cognitive therapy.
CBT treatment is an abbreviated protocol based on manualized, evidence-based treatments for geriatric insomnia (Lichstein & Morin, 2000) and geriatric depression (Thompson, Gallagher-Thompson, & Dick, 1995).
アクティブコンパレータ:Treatment as Usual
No additional treatment besides regular care.
Standard Care - Treatment as usual

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
Insomnia Severity Index
時間枠:3-month follow-up (23weeks post-treatment)
Insomnia Measure
3-month follow-up (23weeks post-treatment)
Hamilton Depression Scale
時間枠:10 weeks Post-treatment
Depression measure
10 weeks Post-treatment
Hamilton Depression Scale
時間枠:3 Month follow-up (23 weeks post treatment)
Depression Measure
3 Month follow-up (23 weeks post treatment)
Insomnia Severity Index
時間枠:10 weeks Post-treatment
Insomnia Measure
10 weeks Post-treatment

二次結果の測定

結果測定
メジャーの説明
時間枠
GDS
時間枠:Pre-Treatment (Baseline/Week 0)
Self-reported Geriatric Depression Scale
Pre-Treatment (Baseline/Week 0)
SOL
時間枠:Pre-Treatment (Baseline/Week 0)
self-reported Sleep Onset Latency
Pre-Treatment (Baseline/Week 0)
WASO
時間枠:Pre-Treatment (Baseline/Week 0)
Wake-time After Sleep Onset
Pre-Treatment (Baseline/Week 0)
SOL
時間枠:10 weeks Post-treatment
Self-reported Sleep onset latency
10 weeks Post-treatment
SOL
時間枠:3-month follow-up (23weeks post-treatment)
Self-reported Sleep onset latency
3-month follow-up (23weeks post-treatment)
GDS
時間枠:10 weeks Post-treatment
Self Reported Geriatric Depression Scale
10 weeks Post-treatment
GDS
時間枠:3-month follow-up (23weeks post-treatment)
Self-reported Geriatric Depression Scale
3-month follow-up (23weeks post-treatment)
WASO
時間枠:10 weeks Post-treatment
Wake-time After Sleep Onset
10 weeks Post-treatment
WASO
時間枠:3-month follow-up (23weeks post-treatment)
Wake-time After Sleep Onset
3-month follow-up (23weeks post-treatment)

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:Kenneth L. Lichstein, Ph.D.、University of Alabama, Tuscaloosa
  • 主任研究者:Forrest Scogin, Ph.D.、University of Alabama, Tuscaloosa

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

2012年6月1日

一次修了 (実際)

2015年3月1日

試験登録日

最初に提出

2012年6月26日

QC基準を満たした最初の提出物

2012年7月19日

最初の投稿 (見積もり)

2012年7月24日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年12月2日

QC基準を満たした最後の更新が送信されました

2015年11月30日

最終確認日

2015年11月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 10-0309
  • 1R34MH086643-01A2 (米国 NIH グラント/契約)

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。

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