Augmented Depression Therapy (ADepT) Case Series
2026年7月28日 更新者：Jay Fournier、Ohio State University
This research study plans to examine the use of Augmented Depression Therapy (ADepT) in order to evaluate what patients think about ADepT and how well it works. ADepT is a type of therapy that builds wellbeing and is being provided to you as standard of care.
ADepT treatment consists of 15 therapy sessions (typically provided weekly) with each session lasting around 60 minutes. Following these sessions, you can receive five optional booster sessions over the next 12 months with each of these lasting around 60 minutes. Ultimately, the timing and duration of these sessions will be determined between you and your provider and scheduled accordingly.
As part of this study you will be randomized (randomly assigned) to different research assessment lengths before the start of treatment and then will complete assessments for the 12 months following the end of the weekly portion of ADepT treatment. The length of your participation will be between 70 weeks to 82 weeks.
調査の概要
研究の種類
介入
入学 (推定)
40
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。
研究連絡先
- 名前：Jay Fournier, Ph.D.
- 電話番号：614-814-6485
- メール：Jay.Fournier@osumc.edu
研究場所
-
-
Ohio
-
Columbus、Ohio、アメリカ、43214
- The Ohio State University Wexner Medical Center
-
コンタクト：
- Jay Fournier, PhD
- 電話番号：614-814-6485
- メール：jay.fournier@osumc.edu
-
-
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:
- Aged 18 -65
- Currently experiencing a major depressive episode based on the Quick Structured Clinical Interview for DSM-5 Disorders (QuickSCID-5; First & Williams, 2021)
- Scoring > 10 on the PHQ-9
- Have sufficient knowledge of written and spoken English to provide consent and utilize therapy resources and take assessment measures throughout the protocol without the assistance of a translator.
Exclusion Criteria:
- Diagnosis of a psychotic or bipolar disorder
- History of learning disabilities or organic brain change (e.g., from injury or from neurological disorders)
- Active alcohol or substance use disorder or level of use that would interfere with ability to engage in ADepT treatment
- Current marked risk to self (self-harm or suicidal ideation) that cannot be managed safely within the ADepT treatment frame
- Patients cannot be enrolled while they are currently receiving psychotherapy from a different provider in line with current clinic policy and APA ethical guidelines. The possibility of switching providers/treatments will be addressed following established departmental policies and procedures, transcranial magnetic stimulation, ketamine, esketamine, or electroconvulsive therapy. Patients receiving a stable dose of an antidepressant agent will be considered eligible.
- Presence of another psychiatric disorder judged to be primary
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 |
|---|---|
|
実験的：3 week baseline + ADepT
Baseline assessments will be made weekly for 3 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
|
実験的：4 week baseline + ADepT
Baseline assessments will be made weekly for 4 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
|
実験的：5 week baseline + ADepT
Baseline assessments will be made weekly for 5 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
|
実験的：6 week baseline + ADepT
Baseline assessments will be made weekly for 6 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
|
実験的：7 week baseline + ADepT
Baseline assessments will be made weekly for 7 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
|
実験的：8 week baseline + ADepT
Baseline assessments will be made weekly for 8 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
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 |
|---|---|---|
|
Acceptability
時間枠：From enrollment to the end of treatment at 82 weeks
|
Patient ratings of treatment acceptability
|
From enrollment to the end of treatment at 82 weeks
|
|
Attrition
時間枠：From enrollment to the end of treatment at 82 weeks.
|
Patient attendance records
|
From enrollment to the end of treatment at 82 weeks.
|
|
Adverse Events
時間枠：From enrollment to the end of treatment at 82 weeks.
|
Self-reported adverse events
|
From enrollment to the end of treatment at 82 weeks.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
時間枠：From enrollment to the end of treatment at 82 weeks.
|
The MADRS is a clinician-administered, 10-item assessment tool used to measure the severity of depressive symptoms and monitor changes in depression over time.
Min=0, Max=60, higher scores indicate worse depression.
|
From enrollment to the end of treatment at 82 weeks.
|
|
Patient Health Questionnaire - 9 Item Version (PHQ-9)
時間枠：From enrollment to the end of treatment at 82 weeks.
|
The PHQ-9 is a 9-item self-report measure of depression severity.
Min=0, Max=27, higher scores indicate worse depression.
|
From enrollment to the end of treatment at 82 weeks.
|
|
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
時間枠：From enrollment to the end of treatment at 82 weeks.
|
The WEMWBS is a 14-item self-report questionnaire designed to measure positive mental wellbeing, including emotional, psychological, and social functioning.
Min=14, Max=70, higher scores indicate higher levels of wellbeing.
|
From enrollment to the end of treatment at 82 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。
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 (推定)
2026年8月1日
一次修了 (推定)
2028年8月31日
研究の完了 (推定)
2028年12月31日
試験登録日
最初に提出
2026年7月23日
QC基準を満たした最初の提出物
2026年7月28日
最初の投稿 (実際)
2026年7月29日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月29日
QC基準を満たした最後の更新が送信されました
2026年7月28日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
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?
はい
IPD プランの説明
Only IRB approved personnel will have access to identifiable data.
De-identified data may be shared with other research groups examining similar questions or as a requirement for publication in certain journals.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
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。