- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT02584764
Internet Supported Group Cognitive Behavior Therapy (CBT) for Hoarding Disorder (HD)
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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Stockholm, Швеция
- Psykiatri Nordväst, Stockholms Läns Sjukvårdsområde (SLSO), Stockholms Läns Landsting
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: CBT with Internet support
16 sessions of Cognitive behavior therapy in group with Internet support between group sessions
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Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Saving Inventory - Revised (SI-R)
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Hoarding Rating Scale - Self Report (HRS-SR)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Hoarding disorder diagnosis
Временное ограничение: Change from baseline to treatment week 8,16, 3- and 12-month follow-up
|
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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Christian Rück, Assoc Prof, Karolinska Institutet
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- Hoarding Pilot
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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