Internet Supported Group Cognitive Behavior Therapy (CBT) for Hoarding Disorder (HD)
2017年8月15日 更新者：Christian Rück、Karolinska Institutet
Internet Supported Group Cognitive Behavior Therapy for Hoarding Disorder - A Pilot Study
The primary aim is to develop, and test the feasibility and efficacy of, a manual based, cognitive behaviour therapy (CBT) treatment for Hoarding Disorder (HD) delivered in a group format combined with an Internet support system. The investigators' secondary aim is to investigate the neurocognitive profile of the participants before and after treatment in order to explore if the treatment might have an impact on neurocognitive functioning and if certain neurocognitive profiles predict outcome.
For the primary aim, the investigators hypothesize that the treatment will be acceptable to participants and decrease symptoms of hoarding. Regarding the secondary aim, the investigators hypothesize that deficiencies in executive functioning, as measured with a neurocognitive battery, will reduce upon completion of treatment and that baseline executive function will be associated with treatment outcome.
調査の概要
研究の種類
介入
入学 (実際)
20
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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Stockholm、スウェーデン
- Psykiatri Nordväst, Stockholms Läns Sjukvårdsområde (SLSO), Stockholms Läns Landsting
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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年歳以上 (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:
- Outpatients
- Male or female
- ≥ 18 years of age
- Currently living in Stockholm county
- Primary diagnosis of Hoarding Disorder according to DSM-5
- Signed informed consent
- Regular access to a computer with Internet and ability to use Internet
- Access to a mobile phone
- Able to participate in group sessions
Exclusion criteria:
- Current substance dependence or misuse
- Life time bipolar disorder or psychosis
- Severe self-rated depressive symptoms (score ≥ 35 on MADRS-S)
- Suicidal ideation (score > 4 on item 9 in MADRS-S)
- Psychotropic medication changes within two months prior to the treatment
- Other current psychological treatment that could affect hoarding symptoms
- Has received more than 10 CBT sessions for Hoarding Disorder
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：なし
- 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：CBT with Internet support
16 sessions of Cognitive behavior therapy in group with Internet support between group sessions
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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 |
|---|---|---|
|
Saving Inventory - Revised (SI-R)
時間枠：Change from baseline to treatment week 8,16, 3- and 12-month follow-up
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The SI-R is a 23-item self-report questionnaire.
It assesses hoarding symptoms in 3 sub-scales: difficulty discarding, clutter and excessive acquisition.
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Change from baseline to treatment week 8,16, 3- and 12-month follow-up
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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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Hoarding Rating Scale - Self Report (HRS-SR)
時間枠：Weekly change during treatment, weeks 1-15
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A 5-item self-report questionnaire assessing hoarding symptoms.
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Weekly change during treatment, weeks 1-15
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Saving Cognitions Inventory (SCI)
時間枠：Change from baseline to treatment week 8,16, 3- and 12-month follow-up
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The questionnaire is a 24-item self-report questionnaire assessing beliefs and attitudes participants experience when trying to discard items.
It is divided in 4 subscales:emotional attachment to objects, beliefs about objects as memory aids, responsibility for not wasting possessions, and the need for control over possessions.
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Change from baseline to treatment week 8,16, 3- and 12-month follow-up
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Clutter Image Rating (CIR)
時間枠：Change from baseline to treatment week 8,16, 3- and 12-month follow-up
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This scale consists of three sets of photographs each containing nine photos of a single room with varying levels of clutter.
Study participants will select the photograph that best resembles his or her own home.
The study investigators will also conduct blinded ratings of the same photos.
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Change from baseline to treatment week 8,16, 3- and 12-month follow-up
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Global Assessment of Functioning (GAF)
時間枠：Change from baseline to treatment week 8,16, 3- and 12-month follow-up
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A scale used to rate the social, occupational, and psychological functioning of the study participants.
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Change from baseline to treatment week 8,16, 3- and 12-month follow-up
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Clinical global impression (CGI)
時間枠：Change from baseline to treatment week 8,16, 3- and 12-month follow-up
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A 7 point scale to rate how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
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Change from baseline to treatment week 8,16, 3- and 12-month follow-up
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EuroQol- 5 Dimension (EQ-5D)
時間枠：Change from baseline to treatment week 8,16, 3- and 12-month follow-up
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A self-rating scale assessing quality of life i 5 dimensions.
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Change from baseline to treatment week 8,16, 3- and 12-month follow-up
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Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
時間枠：Change from baseline to treatment week 8,16, 3- and 12-month follow-up
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In this questionnaire, study participants register their monthly health care consumption (e.g.
GP visits) as well as time spent in informal health enhancing activities (e.g.
self-help groups and informal care from friends).
Additionally, work loss and work cutback both at work and in the domestic realm is measured.
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Change from baseline to treatment week 8,16, 3- and 12-month follow-up
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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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Hoarding disorder diagnosis
時間枠：Change from baseline to treatment week 8,16, 3- and 12-month follow-up
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Presence of Hoarding Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
Assessed by the investigators using the Structured Interview for Hoarding Disorder.
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Change from baseline to treatment week 8,16, 3- and 12-month follow-up
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Comorbid psychiatric diagnoses
時間枠：Change from baseline to treatment week 8,16, 3- and 12-month follow-up
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Presence of psychiatric diagnoses other than Hoarding Disorder.
Assessed by the investigators using the M.I.N.I.
International Neuropsychiatric Interview (M.I.N.I. 6.0).
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Change from baseline to treatment week 8,16, 3- and 12-month follow-up
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Neuropsychological Test Battery (CANTAB)
時間枠：Change from baseline to treatment week 16
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Cambridge Automated Neuropsychological Test Battery (CANTAB) will be used to test the study participants in 3 aspects of executive function: shifting and flexibility of attention, visuospatial working memory and response inhibition
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Change from baseline to treatment week 16
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Client Satisfaction Questionnaire - 8 (CSQ-8)
時間枠：At treatment week 16
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An 8-item questionnaire measuring treatment satisfaction and acceptability.
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At treatment week 16
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Homework adherence
時間枠：Weekly change during treatment, weeks 1-15
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Self-reported time spent on homework each week.
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Weekly change during treatment, weeks 1-15
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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
捜査官
- 主任研究者：Christian Rück, Assoc Prof、Karolinska Institutet
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)
2015年10月1日
一次修了 (実際)
2017年6月1日
研究の完了 (実際)
2017年6月1日
試験登録日
最初に提出
2015年10月13日
QC基準を満たした最初の提出物
2015年10月21日
最初の投稿 (見積もり)
2015年10月23日
学習記録の更新
投稿された最後の更新 (実際)
2017年8月18日
QC基準を満たした最後の更新が送信されました
2017年8月15日
最終確認日
2017年8月1日
詳しくは
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