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

Sponsor
Karolinska Institutet (Other)
Overall Status
Completed
CT.gov ID
NCT02584764
Collaborator
(none)
20
1
1
20
1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive behavior therapy
  • Behavioral: Internet support
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Internet Supported Group Cognitive Behavior Therapy for Hoarding Disorder - A Pilot Study
Actual Study Start Date :
Oct 1, 2015
Actual Primary Completion Date :
Jun 1, 2017
Actual Study Completion Date :
Jun 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: CBT with Internet support

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

Behavioral: Cognitive behavior therapy
Other Names:
  • CBT
  • Behavioral: Internet support

    Outcome Measures

    Primary Outcome Measures

    1. Saving Inventory - Revised (SI-R) [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.

    Secondary Outcome Measures

    1. Hoarding Rating Scale - Self Report (HRS-SR) [Weekly change during treatment, weeks 1-15]

      A 5-item self-report questionnaire assessing hoarding symptoms.

    2. Saving Cognitions Inventory (SCI) [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.

    3. Clutter Image Rating (CIR) [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.

    4. Global Assessment of Functioning (GAF) [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.

    5. Clinical global impression (CGI) [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.

    6. EuroQol- 5 Dimension (EQ-5D) [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.

    7. Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P) [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.

    Other Outcome Measures

    1. Hoarding disorder diagnosis [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.

    2. Comorbid psychiatric diagnoses [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).

    3. Neuropsychological Test Battery (CANTAB) [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

    4. Client Satisfaction Questionnaire - 8 (CSQ-8) [At treatment week 16]

      An 8-item questionnaire measuring treatment satisfaction and acceptability.

    5. Homework adherence [Weekly change during treatment, weeks 1-15]

      Self-reported time spent on homework each week.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Psykiatri Nordväst, Stockholms Läns Sjukvårdsområde (SLSO), Stockholms Läns Landsting Stockholm Sweden

    Sponsors and Collaborators

    • Karolinska Institutet

    Investigators

    • Principal Investigator: Christian Rück, Assoc Prof, Karolinska Institutet

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Christian Rück, Associate Professor, Karolinska Institutet
    ClinicalTrials.gov Identifier:
    NCT02584764
    Other Study ID Numbers:
    • Hoarding Pilot
    First Posted:
    Oct 23, 2015
    Last Update Posted:
    Aug 18, 2017
    Last Verified:
    Aug 1, 2017
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 18, 2017