Hybrid Dialectical Behavior Therapy for Veterans to Further Reduce Emotion Regulation Problems and Trauma Symptoms (REFRESH)
2026年6月11日 更新者：Arkin
REfreshment of Dialectical Behaviour Therapy for Veterans to Further Reduce Symptoms and Prevent Relapse of Post-traumatic Stress Disorder and Emotion Regulation Symptoms by Guided Self-Help
Around 10% of post-active veterans experience post-traumatic stress disorder (PTSD) many years post-mission.
PTSD in veterans is frequently associated with challenges in emotion regulation, aggression, suicidality, and financial and psychosocial stress.
In 2018, a 12-week clinical treatment programme, the Veterans Intensive Treatment Unit (VIBU), was developed for veterans experiencing these psychiatric symptoms, for whom conventional treatments had proven ineffective.
The VIBU provides patients with trauma-focused and dialectical behaviour therapy (DBT).
A recent study revealed that the VIBU was effective in reducing psychiatric symptoms.
However, a recurrence of symptoms was observed in patients a few months after discharge.
Consequently, an aftercare programme consisting of hybrid DBT is offered to consolidate and repeat the DBT skills and apply them in daily life.
調査の概要
研究の種類
介入
入学 (推定)
24
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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North Holland
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Amstelveen、North Holland、オランダ、1186 AM
- 募集
- Sinai Center
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コンタクト：
- Kathleen Thomaes, Senior researcher
- 電話番号：020 545 7200
- メール：refreshonderzoek@sinaicentrum.nl
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コンタクト：
- Mariejean Albers, MSc
- メール：mariejean.albers@sinaicentrum.nl
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主任研究者：
- Kathleen Thomaes, Senior researcher
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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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Adult veteran (18 years or older), treated at Sinai Center, with knowledge of DBT
- Primairy diagnosis of PTSD, determined with CAPS-5, resulting from war-related traumas
- Stable for four weeks on their medication (type and doses)
- Able to to do online homework assignments and communicate with their therapist via an eHealth platform
- Dutch speaking
Exclusion Criteria:
- Chronic psychosis (psychotic features as comorbidity from PTSD is allowed) or bipolar disorder type 1
- IQ below 80 or cognitive disorders
- Severe self-harming behaviour, such as auto-mutilation or suicidal ideations as main problem
- Following day treatments or other intensive treatment for residual symptoms
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：単一グループの割り当て
- 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 |
|---|---|
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実験的：Hybrid DBT
All participants will follow the same hybrid DBT program (i.e., group sessions, individual sessions and online homework assignments).
Randomization will determine the length of the waiting period between baseline and start of the intervention (i.e., hybrid DBT).
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Hybrid DBT will be provided to veterans who have followed a 3-month inpatient DBT treatment.
The hybrid DBT will include face-to-face skill groups, online individual sessions and online homework assignements.
他の名前：
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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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PTSD Checklist for the DSM-5 (PCL-5)
時間枠：From the baseline to the end of the follow-up period (between 12-17 months)
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One of the two main outcomes of this study is PTSD symptom score.
The self-report questionnaire contains 20 questions with answer options ranging from '0 = Not at all' to '4 = Extremely', resulting in a score between 0-80.
A higher score indicates more likelyhood of having PTSD.
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From the baseline to the end of the follow-up period (between 12-17 months)
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Difficulties in Emotion Regulation Scale Short Form (DERS-SF)
時間枠：From the baseline to the end of the follow-up period (between 12-17 months)
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One of the two main outcomes of this study is emotion dysregulation severity.
The self-report questionnaire contains 18 questions with answer options from '1 = Almost never' to '5 = Almost always', resulting in a score between 18-90.
A higher score indicates more difficulties with regulation emotions.
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From the baseline to the end of the follow-up period (between 12-17 months)
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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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REFRESH - monitoring
時間枠：From enrollment to (favourably) the end of the follow-up period (between 12-17 months)
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Weekly short questionnaire (i.e., 10 questions) specifically tailored to this population to monitore PTSD, emotion regulation, substance use and DBT skills.
Answer options range from '1 = Totally disagree' to '10 = Totally agree', resulting in a score between 10-100.
A higher score means a worse outcome.
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From enrollment to (favourably) the end of the follow-up period (between 12-17 months)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Outcome Questionnaire (OQ-30.2)
時間枠：From the baseline to the end of the follow-up period (between 12-17 months)
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This self-report questionnaire gives an indication of overall psychiatric symptoms and entails 30 items.
Answers options go from '0 = almost never' to '4 = almost alywas'.
The score ranges between 0-120, with a higher score indicating a worse outcome.
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From the baseline to the end of the follow-up period (between 12-17 months)
|
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Alcohol Use Disorders Identification Test (AUDIT)
時間枠：From the baseline to the end of the follow-up period (between 12-17 months)
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This self-report questionnaire contains 10 items with answer options from '0 = never' to '4 = high usage', resulting in a score between 0-40.
A higher score indicates having alcohol problems.
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From the baseline to the end of the follow-up period (between 12-17 months)
|
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Drug Use Disorders Identification Test (DUDIT)
時間枠：From the baseline to the end of the follow-up period (between 12-17 months)
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This self-report questionnaire contains 11 items with answer options from '0 = never' to '4 = high usage', resulting in a score between 0-40.
A higher score indicates having drug problems.
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From the baseline to the end of the follow-up period (between 12-17 months)
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Individual Recovery Outcome Counter (i-ROC)
時間枠：From the baseline to the end of the follow-up period (between 12-17 months)
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This questionnaires measures wellbeing outcomes.
This self-report questionnaire of 12 items uses answer options from '1 = Never' to '6 = Always', resulting in a score ranging between 12-72.
A higher score indicates a better outcome.
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From the baseline to the end of the follow-up period (between 12-17 months)
|
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General Self-Efficacy Scale (GSES)
時間枠：From the baseline to the end of the follow-up period (between 12-17 months)
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This questionnaire measures self-efficacy.
This self-report questionnaire of 10 items, with answer options from '1 = Not at all true' to '4 = Exactly true', with scores ranging from 10-40.
A higher score indicates more self-efficacy.
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From the baseline to the end of the follow-up period (between 12-17 months)
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Dialectical behavioral therapy skills (DBT-skills)
時間枠：From the baseline to the end of the follow-up period (between 12-17 months)
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This questionnaire asks participants about their use of DBT skills.
This self-report questionnaire of 17 items has answer options from '1 = never' to '5 = often', giving a score rangen between 17-85.
A higher score indicates a positive outcome.
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From the baseline to the end of the follow-up period (between 12-17 months)
|
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Level of Personality Functioning Scale (LPFS 2.0)
時間枠：From the baseline to the end of the follow-up period (between 12-17 months)
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This questionnaire measures the level of personality functioning.
This self-report questionnaire contains 12 items, with answers ranging from '1 = not often true' to '4 = often true', resulting in a score between 12-48.
A higher score indicates a worse outcome.
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From the baseline to the end of the follow-up period (between 12-17 months)
|
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Inventarisatielijst Sociale Betrokkenheid (ISB)
時間枠：From the baseline to the end of the follow-up period (between 12-17 months)
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This questionnaire is about social wellbeing.
This self-report questions contains 11 items, with results from '1 = almost never' to '4 = almost always', resulting in a score between 11-44.
A higher score indicates a positive outcome.
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From the baseline to the end of the follow-up period (between 12-17 months)
|
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Aggression questionnaire (AGQ)
時間枠：From the baseline to the end of the follow-up period (between 12-17 months)
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This questionnaire measures different forms of aggression.
This self-report questionnaire contains 29 items, with answer from '1 = Extremely uncharacteristic' to '5 = Extremely characteristic', resulting in a score between 29-145.
A higher score indicates a worse outcome.
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From the baseline to the end of the follow-up period (between 12-17 months)
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Suicidal Ideation Attributes Scale (SIDAS)
時間枠：From the baseline to the end of the follow-up period (between 12-17 months)
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This questionnaire measures suicidal ideation.
This self-report questionnaire contains 5 items, with answer from '0 = Not at all' to '10 = Completely', resulting in a score between 0-50.
A higher score indicates a higher level of suicidal ideation.
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From the baseline to the end of the follow-up period (between 12-17 months)
|
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Non-Suicidal Self-Injury Assement Tool screener (NSSI-AT screener)
時間枠：From the baseline to the end of the follow-up period (between 12-17 months)
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This questionnaire measures self-injurious behavior.
This self-report questionnaire contains 7 items asking about the frequency and severity of self-injurious behaviour.
There is no scoring.
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From the baseline to the end of the follow-up period (between 12-17 months)
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Childhood Trauma Questionnaire (CTQ)
時間枠：At baseline
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This questionnaire assess childhood maltreatment.
This self-report questionnaire contains 28 items, with answers from '1 = Never true' to '5 = Very often true', resulting in a score between 28-140.
A higher score indicate a worse outcome.
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At baseline
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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。
スポンサー
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)
2026年6月1日
一次修了 (推定)
2028年9月1日
研究の完了 (推定)
2028年10月1日
試験登録日
最初に提出
2026年2月23日
QC基準を満たした最初の提出物
2026年6月11日
最初の投稿 (実際)
2026年6月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月17日
QC基準を満たした最後の更新が送信されました
2026年6月11日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- REFRESH
- NL-010470 (レジストリ識別子：METC Amsterdam)
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
IPD プランの説明
Very sensitive personal information.
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いいえ
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いいえ
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