Hoarding DisorderNCT02584764
Internet Supported Group Cognitive Behavior Therapy (CBT) for Hoarding Disorder (HD)
A study testing Cognitive behavior therapy and Internet support in people with Hoarding Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hoarding Disorder
- What is being tested?
- Cognitive behavior therapy and Internet support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Regular access to a computer with Internet and ability to use Internet
- Access to a mobile phone
- Able to participate in group sessions
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Psykiatri Nordväst, Stockholms Läns Sjukvårdsområde (SLSO), Stockholms Läns Landsting
Stockholm
About this study
Official title: 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.
- Conditions
- Hoarding Disorder
- Being tested
- Cognitive behavior therapy, Internet support
- Medical subject headings
- Hoarding Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavior therapyBehavioural
Also called CBT
Internet supportBehavioural
| Study group | Role | What they receive |
|---|---|---|
| CBT with Internet support | Experimental | 16 sessions of Cognitive behavior therapy in group with Internet support between group sessions Receives: Behavioral: Cognitive behavior therapy; Behavioral: Internet support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to treatment week 8,16, 3- and 12-month follow-up
Secondary outcomes (7)
Hoarding Rating Scale - Self Report (HRS-SR)
A 5-item self-report questionnaire assessing hoarding symptoms.
Measured: Weekly change during treatment, weeks 1-15
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.
Measured: Change from baseline to treatment week 8,16, 3- and 12-month follow-up
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.
Measured: Change from baseline to treatment week 8,16, 3- and 12-month follow-up
Global Assessment of Functioning (GAF)
A scale used to rate the social, occupational, and psychological functioning of the study participants.
Measured: Change from baseline to treatment week 8,16, 3- and 12-month follow-up
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.
Measured: Change from baseline to treatment week 8,16, 3- and 12-month follow-up
EuroQol- 5 Dimension (EQ-5D)
A self-rating scale assessing quality of life i 5 dimensions.
Measured: 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)
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.
Measured: Change from baseline to treatment week 8,16, 3- and 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hoarding DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Rück, Karolinska Institutet
- Investigators
- Christian Rück, Assoc Prof, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584764
- Sponsor's protocol ID
- Hoarding Pilot
- Status last verified
- Aug 2017
- First submitted
- 13 Oct 2015
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Supported Group Cognitive Behavior Therapy for Hoarding Disorder - A Pilot Study
- ClinicalTrials.gov ID
- NCT02584764
- Acronym / sponsor ID
- Hoarding Pilot
- Conditions
- Hoarding Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 23 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBT with Internet support | Experimental | Behavioral: Cognitive behavior therapy, Behavioral: Internet support16 sessions of Cognitive behavior therapy in group with Internet support between group sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
Key exclusion criteria (7 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavior therapyAlso: CBT | Behavioural | CBT with Internet support |
| Internet support | Behavioural | CBT with Internet support |
Primary outcome
Saving Inventory - Revised (SI-R)
Time frame: 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.
7 secondary outcomes
Hoarding Rating Scale - Self Report (HRS-SR)
Time frame: Weekly change during treatment, weeks 1-15
Saving Cognitions Inventory (SCI)
Time frame: Change from baseline to treatment week 8,16, 3- and 12-month follow-up
Clutter Image Rating (CIR)
Time frame: Change from baseline to treatment week 8,16, 3- and 12-month follow-up
Global Assessment of Functioning (GAF)
Time frame: Change from baseline to treatment week 8,16, 3- and 12-month follow-up
Clinical global impression (CGI)
Time frame: Change from baseline to treatment week 8,16, 3- and 12-month follow-up
EuroQol- 5 Dimension (EQ-5D)
Time frame: 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)
Time frame: Change from baseline to treatment week 8,16, 3- and 12-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Rück, Assoc Prof principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavior therapy and Internet support in people with Hoarding Disorder, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saving Inventory - Revised (SI-R) (time frame: Change from baseline to treatment week 8,16, 3- and 12-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.