Internet Supported Group Cognitive Behavior Therapy (CBT) for Hoarding Disorder (HD)
15 augustus 2017 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
20
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
-
Stockholm, Zweden
- Psykiatri Nordväst, Stockholms Läns Sjukvårdsområde (SLSO), Stockholms Läns Landsting
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: CBT with Internet support
16 sessions of Cognitive behavior therapy in group with Internet support between group sessions
|
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Saving Inventory - Revised (SI-R)
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Hoarding Rating Scale - Self Report (HRS-SR)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Hoarding disorder diagnosis
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: At treatment week 16
|
An 8-item questionnaire measuring treatment satisfaction and acceptability.
|
At treatment week 16
|
|
Homework adherence
Tijdsspanne: Weekly change during treatment, weeks 1-15
|
Self-reported time spent on homework each week.
|
Weekly change during treatment, weeks 1-15
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Christian Rück, Assoc Prof, Karolinska Institutet
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 oktober 2015
Primaire voltooiing (Werkelijk)
1 juni 2017
Studie voltooiing (Werkelijk)
1 juni 2017
Studieregistratiedata
Eerst ingediend
13 oktober 2015
Eerst ingediend dat voldeed aan de QC-criteria
21 oktober 2015
Eerst geplaatst (Schatting)
23 oktober 2015
Updates van studierecords
Laatste update geplaatst (Werkelijk)
18 augustus 2017
Laatste update ingediend die voldeed aan QC-criteria
15 augustus 2017
Laatst geverifieerd
1 augustus 2017
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Hoarding Pilot
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .