Internet Supported Group Cognitive Behavior Therapy (CBT) for Hoarding Disorder (HD)
15. august 2017 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
20
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Stockholm, Sverige
- Psykiatri Nordväst, Stockholms Läns Sjukvårdsområde (SLSO), Stockholms Läns Landsting
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: CBT with Internet support
16 sessions of Cognitive behavior therapy in group with Internet support between group sessions
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Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Saving Inventory - Revised (SI-R)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Hoarding Rating Scale - Self Report (HRS-SR)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Hoarding disorder diagnosis
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Christian Rück, Assoc Prof, Karolinska Institutet
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. oktober 2015
Primær fullføring (Faktiske)
1. juni 2017
Studiet fullført (Faktiske)
1. juni 2017
Datoer for studieregistrering
Først innsendt
13. oktober 2015
Først innsendt som oppfylte QC-kriteriene
21. oktober 2015
Først lagt ut (Anslag)
23. oktober 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. august 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. august 2017
Sist bekreftet
1. august 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Hoarding Pilot
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