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Internet Supported Group Cognitive Behavior Therapy (CBT) for Hoarding Disorder (HD)

15 de agosto de 2017 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

20

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Suecia
      • Stockholm, Suecia
        • Psykiatri Nordväst, Stockholms Läns Sjukvårdsområde (SLSO), Stockholms Läns Landsting

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

  • 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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: CBT with Internet support
16 sessions of Cognitive behavior therapy in group with Internet support between group sessions
Conductual: Terapia de comportamiento cognitivo
Otros nombres:
  • TCC
Conductual: Internet support

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Saving Inventory - Revised (SI-R)
Periodo de tiempo: Change from baseline to treatment week 8,16, 3- and 12-month follow-up
The SI-R is a 23-item self-report questionnaire. It assesses hoarding symptoms in 3 sub-scales: difficulty discarding, clutter and excessive acquisition.
Change from baseline to treatment week 8,16, 3- and 12-month follow-up

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Hoarding Rating Scale - Self Report (HRS-SR)
Periodo de tiempo: Weekly change during treatment, weeks 1-15
A 5-item self-report questionnaire assessing hoarding symptoms.
Weekly change during treatment, weeks 1-15
Saving Cognitions Inventory (SCI)
Periodo de tiempo: Change from baseline to treatment week 8,16, 3- and 12-month follow-up
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.
Change from baseline to treatment week 8,16, 3- and 12-month follow-up
Clutter Image Rating (CIR)
Periodo de tiempo: Change from baseline to treatment week 8,16, 3- and 12-month follow-up
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.
Change from baseline to treatment week 8,16, 3- and 12-month follow-up
Global Assessment of Functioning (GAF)
Periodo de tiempo: Change from baseline to treatment week 8,16, 3- and 12-month follow-up
A scale used to rate the social, occupational, and psychological functioning of the study participants.
Change from baseline to treatment week 8,16, 3- and 12-month follow-up
Clinical global impression (CGI)
Periodo de tiempo: Change from baseline to treatment week 8,16, 3- and 12-month follow-up
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.
Change from baseline to treatment week 8,16, 3- and 12-month follow-up
EuroQol- 5 Dimension (EQ-5D)
Periodo de tiempo: Change from baseline to treatment week 8,16, 3- and 12-month follow-up
A self-rating scale assessing quality of life i 5 dimensions.
Change from baseline to treatment week 8,16, 3- and 12-month follow-up
Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
Periodo de tiempo: Change from baseline to treatment week 8,16, 3- and 12-month follow-up
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.
Change from baseline to treatment week 8,16, 3- and 12-month follow-up

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Hoarding disorder diagnosis
Periodo de tiempo: 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.
Change from baseline to treatment week 8,16, 3- and 12-month follow-up
Comorbid psychiatric diagnoses
Periodo de tiempo: Change from baseline to treatment week 8,16, 3- and 12-month follow-up
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).
Change from baseline to treatment week 8,16, 3- and 12-month follow-up
Neuropsychological Test Battery (CANTAB)
Periodo de tiempo: Change from baseline to treatment week 16
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
Change from baseline to treatment week 16
Client Satisfaction Questionnaire - 8 (CSQ-8)
Periodo de tiempo: At treatment week 16
An 8-item questionnaire measuring treatment satisfaction and acceptability.
At treatment week 16
Homework adherence
Periodo de tiempo: Weekly change during treatment, weeks 1-15
Self-reported time spent on homework each week.
Weekly change during treatment, weeks 1-15

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Karolinska Institutet

Investigadores

  • Investigador principal: Christian Rück, Assoc Prof, Karolinska Institutet

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de octubre de 2015

Finalización primaria (Actual)

1 de junio de 2017

Finalización del estudio (Actual)

1 de junio de 2017

Fechas de registro del estudio

Enviado por primera vez

13 de octubre de 2015

Primero enviado que cumplió con los criterios de control de calidad

21 de octubre de 2015

Publicado por primera vez (Estimar)

23 de octubre de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de agosto de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

15 de agosto de 2017

Última verificación

1 de agosto de 2017

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • Hoarding Pilot

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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