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

Primary Purpose

Hoarding Disorder

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cognitive behavior therapy
Internet support
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hoarding Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CBT with Internet support

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Hoarding Rating Scale - Self Report (HRS-SR)
A 5-item self-report questionnaire assessing hoarding symptoms.
Saving Cognitions Inventory (SCI)
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.
Clutter Image Rating (CIR)
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.
Global Assessment of Functioning (GAF)
A scale used to rate the social, occupational, and psychological functioning of the study participants.
Clinical global impression (CGI)
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.
EuroQol- 5 Dimension (EQ-5D)
A self-rating scale assessing quality of life i 5 dimensions.
Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
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.

Full Information

First Posted
October 13, 2015
Last Updated
August 15, 2017
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT02584764
Brief Title
Internet Supported Group Cognitive Behavior Therapy (CBT) for Hoarding Disorder (HD)
Official Title
Internet Supported Group Cognitive Behavior Therapy for Hoarding Disorder - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hoarding Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT with Internet support
Arm Type
Experimental
Arm Description
16 sessions of Cognitive behavior therapy in group with Internet support between group sessions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavior therapy
Other Intervention Name(s)
CBT
Intervention Type
Behavioral
Intervention Name(s)
Internet support
Primary Outcome Measure Information:
Title
Saving Inventory - Revised (SI-R)
Description
The SI-R is a 23-item self-report questionnaire. It assesses hoarding symptoms in 3 sub-scales: difficulty discarding, clutter and excessive acquisition.
Time Frame
Change from baseline to treatment week 8,16, 3- and 12-month follow-up
Secondary Outcome Measure Information:
Title
Hoarding Rating Scale - Self Report (HRS-SR)
Description
A 5-item self-report questionnaire assessing hoarding symptoms.
Time Frame
Weekly change during treatment, weeks 1-15
Title
Saving Cognitions Inventory (SCI)
Description
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.
Time Frame
Change from baseline to treatment week 8,16, 3- and 12-month follow-up
Title
Clutter Image Rating (CIR)
Description
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.
Time Frame
Change from baseline to treatment week 8,16, 3- and 12-month follow-up
Title
Global Assessment of Functioning (GAF)
Description
A scale used to rate the social, occupational, and psychological functioning of the study participants.
Time Frame
Change from baseline to treatment week 8,16, 3- and 12-month follow-up
Title
Clinical global impression (CGI)
Description
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.
Time Frame
Change from baseline to treatment week 8,16, 3- and 12-month follow-up
Title
EuroQol- 5 Dimension (EQ-5D)
Description
A self-rating scale assessing quality of life i 5 dimensions.
Time Frame
Change from baseline to treatment week 8,16, 3- and 12-month follow-up
Title
Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
Description
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.
Time Frame
Change from baseline to treatment week 8,16, 3- and 12-month follow-up
Other Pre-specified Outcome Measures:
Title
Hoarding disorder diagnosis
Description
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.
Time Frame
Change from baseline to treatment week 8,16, 3- and 12-month follow-up
Title
Comorbid psychiatric diagnoses
Description
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).
Time Frame
Change from baseline to treatment week 8,16, 3- and 12-month follow-up
Title
Neuropsychological Test Battery (CANTAB)
Description
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
Time Frame
Change from baseline to treatment week 16
Title
Client Satisfaction Questionnaire - 8 (CSQ-8)
Description
An 8-item questionnaire measuring treatment satisfaction and acceptability.
Time Frame
At treatment week 16
Title
Homework adherence
Description
Self-reported time spent on homework each week.
Time Frame
Weekly change during treatment, weeks 1-15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Rück, Assoc Prof
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psykiatri Nordväst, Stockholms Läns Sjukvårdsområde (SLSO), Stockholms Läns Landsting
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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