NCT02584764

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 23, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

August 18, 2017

Status Verified

August 1, 2017

Enrollment Period

1.7 years

First QC Date

October 13, 2015

Last Update Submit

August 15, 2017

Conditions

Hoarding Disorder

Outcome Measures

Primary Outcomes (1)

  • Saving Inventory - Revised (SI-R)

    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

Secondary Outcomes (7)

  • Hoarding Rating Scale - Self Report (HRS-SR)

    Weekly change during treatment, weeks 1-15

  • Saving Cognitions Inventory (SCI)

    Change from baseline to treatment week 8,16, 3- and 12-month follow-up

  • Clutter Image Rating (CIR)

    Change from baseline to treatment week 8,16, 3- and 12-month follow-up

  • Global Assessment of Functioning (GAF)

    Change from baseline to treatment week 8,16, 3- and 12-month follow-up

  • Clinical global impression (CGI)

    Change from baseline to treatment week 8,16, 3- and 12-month follow-up

  • +2 more secondary outcomes

Other Outcomes (5)

  • Hoarding disorder diagnosis

    Change from baseline to treatment week 8,16, 3- and 12-month follow-up

  • Comorbid psychiatric diagnoses

    Change from baseline to treatment week 8,16, 3- and 12-month follow-up

  • Neuropsychological Test Battery (CANTAB)

    Change from baseline to treatment week 16

  • +2 more other outcomes

Study Arms (1)

CBT with Internet support

EXPERIMENTAL

16 sessions of Cognitive behavior therapy in group with Internet support between group sessions

Behavioral: Cognitive behavior therapyBehavioral: Internet support

Interventions

Cognitive behavior therapyBEHAVIORAL
Also known as: CBT
CBT with Internet support
Internet supportBEHAVIORAL
CBT with Internet support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psykiatri Nordväst, Stockholms Läns Sjukvårdsområde (SLSO), Stockholms Läns Landsting

Stockholm, Sweden

Location

MeSH Terms

Conditions

Hoarding Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Obsessive-Compulsive DisorderAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Christian Rück, Assoc Prof

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 13, 2015

First Posted

October 23, 2015

Study Start

October 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

August 18, 2017

Record last verified: 2017-08

Locations

SE(1)