Present- Versus Past-focused Therapy for PTSD and Substance Use Disorder
2019年5月2日 更新者:Karen Krinsley、VA Boston Healthcare System
Pilot Study of an Integrated Exposure-Based Model for Posttraumatic Stress Disorder and Substance Use Disorder
This study compares Creating Change, a new past-focused behavioral therapy for posttraumatic stress disorder (PTSD)/substance use disorder (SUD), to Seeking Safety, an evidence-based present-focused behavioral therapy for PTSD/SUD.
調査の概要
詳細な説明
This study evaluates a new behavioral therapy model, Creating Change (CC) for PTSD/SUD.
CC helps clients explore the past as a step in their recovery process.
It has major public health relevance in that it is a low-cost, flexible model designed for all trauma and substance abuse types, both genders, and all clinical settings.
It has particular relevance for VA in that many veterans suffer from PTSD and SUD.
The new model demonstrated positive results in two pilot studies.
研究の種類
介入
入学 (実際)
52
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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Massachusetts
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Boston、Massachusetts、アメリカ、02459
- VA Boston Healthcare System
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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~65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:
- Meet Diagnostic and Statistical Manual (DSM-IV) criteria for current PTSD and current substance use disorder
- Have used a substance in the 60 days prior to intake
- Outpatient
- Plan to stay in Boston for the next 6 months
- If on psychiatric medication, are on a stable regimen for at least 4 weeks prior to participation in the study
- Have a stable mailing address and live nearby enough to come to VA Boston for treatment
- Able to sign informed consent
- Willing to participate in all assessments and urine testing
- Willing to provide a release of information for study staff to contact treaters as needed for clinical concerns
Exclusion Criteria:
- Any current acute medical condition that would either interfere with the patient's ability to attend treatment, or would be of such severity as to affect the patient's psychological functioning
- Current bipolar I disorder, schizophrenia or other psychotic disorders, mental retardation, or organic mental disorder
- Any obvious clinical sign that the patient is not sufficiently stable to participate in the treatment, or notification by the patient's primary providers that participation would be contraindicated
- Dangerousness that would present a threat to staff or patients (e.g., history of assault within the past 6 months)
- The patient is mandated to treatment
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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アクティブコンパレータ:Seeking Safety (SS)
17 sessions of present-focused therapy Seeking Safety
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Seeking Safety is a present-focused, evidence-based cognitive-behavioral therapy for integrated treatment of patients with PTSD/SUD.
It is a cognitive-behavioral therapy comprising 25 topics, each a coping skill relevant to both disorders.
In this study 17 of the 25 topics were conducted, one per weekly, one-hour, individual session.
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実験的:Creating Change (CC)
17 sessions of past-focused Creating Change
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Creating Change is a past-focused, integrated, cognitive-behavioral therapy for PTSD/SUD.
It has 17 topics, which in this study were delivered in weekly one-hour sessions, in individual format.
The treatment explores how PTSD and SUD arose and interacted across the patient's life, including constructing a narrative of its meaning, processing associated emotions and memories, and exploring themes related to these.
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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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Change in PTSD Checklist total score - from baseline through end of treatment and 3-month followup
時間枠:Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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PTSD symptoms assessed via self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in diagnosis of PTSD on the MINI Neuropsychiatric Interview - from baseline through end of treatment and 3-month followup
時間枠:Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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PTSD diagnosis as assessed by a trained interviewer
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in Addiction Severity Index alcohol composite score - from baseline through end of treatment and 3-month followup
時間枠:Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Alcohol use and associated problems as measured by blinded-interviewer measure Composite.
These outcome variables will be measured at baseline, end of treatment and 3-month followup.
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in Addiction Severity Index drug composite score - from baseline through end of treatment and 3-month followup
時間枠:Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Drug use and associated problems as measured by blinded-interviewer measure Composite.
These outcome variables will be measured at baseline, end of treatment and 3-month followup.
Urinanlysis/breathalyzer will be obtained to verify ASI self-report.
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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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 |
---|---|---|
Change in Quality of Life Satisfaction & Enjoyment Scale - from baseline through end of treatment and 3-month followup
時間枠:Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in Brief Symptom Inventory-Global Severity Index - from baseline through end of treatment and 3-month followup
時間枠:Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in Beliefs About Substance Use - from baseline through end of treatment and 3-month followup
時間枠:Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in General Self-Efficacy - from baseline through end of treatment and 3-month followup: Self-report measure
時間枠:Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in Coping Self-Efficacy Scale - from baseline through end of treatment and 3-month followup
時間枠:Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in World Assumptions Scale - from baseline through end of treatment and 3-month followup
時間枠:Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in Trauma Related Guilt Inventory - from baseline through end of treatment and 3-month followup
時間枠:Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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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。
捜査官
- 主任研究者:Karen E. Krinsley, Ph.D.、VA Boston Healthcare System
- 主任研究者:Lisa M Najavits, PhD、VA Boston Healthcare System
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。
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
2011年1月1日
一次修了 (実際)
2015年3月1日
研究の完了 (実際)
2015年3月1日
試験登録日
最初に提出
2011年1月10日
QC基準を満たした最初の提出物
2011年1月10日
最初の投稿 (見積もり)
2011年1月11日
学習記録の更新
投稿された最後の更新 (実際)
2019年5月3日
QC基準を満たした最後の更新が送信されました
2019年5月2日
最終確認日
2019年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- SPLA-CX000308-01 (VA CSRD)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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。
物質使用障害の臨床試験
Seeking Safety (SS)の臨床試験
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University of Massachusetts, WorcesterNational Institute on Alcohol Abuse and Alcoholism (NIAAA)完了
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Treatment InnovationsNational Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)完了
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Asklepios Kliniken Hamburg GmbHUniversity of Kiel完了気道管理 | ラリンジアル マスク エアウェイ | 光ファイバー挿管
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Chang Gung Memorial HospitalChina Medical University, China; China Medical University Hospital; National Science Council,... と他の協力者わからない
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China Medical University HospitalChina Medical University, China; Chang Gung Memorial Hospital; National Research Program for Biopharmaceuticals...わからない
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University of California, Los AngelesPatient-Centered Outcomes Research Institute; Brown University; Duke University; University of Utah と他の協力者募集