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

15. august 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CBT with Internet support
16 sessions of Cognitive behavior therapy in group with Internet support between group sessions
Adfærdsmæssigt: Kognitiv adfærdsterapi
Andre navne:
  • CBT
Adfærdsmæssigt: Internet support

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Saving Inventory - Revised (SI-R)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hoarding Rating Scale - Self Report (HRS-SR)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hoarding disorder diagnosis
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: At treatment week 16
An 8-item questionnaire measuring treatment satisfaction and acceptability.
At treatment week 16
Homework adherence
Tidsramme: Weekly change during treatment, weeks 1-15
Self-reported time spent on homework each week.
Weekly change during treatment, weeks 1-15

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Karolinska Institutet

Efterforskere

  • Ledende efterforsker: Christian Rück, Assoc Prof, Karolinska Institutet

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2015

Primær færdiggørelse (Faktiske)

1. juni 2017

Studieafslutning (Faktiske)

1. juni 2017

Datoer for studieregistrering

Først indsendt

13. oktober 2015

Først indsendt, der opfyldte QC-kriterier

21. oktober 2015

Først opslået (Skøn)

23. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. august 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. august 2017

Sidst verificeret

1. august 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Hoarding Pilot

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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