Obsessive-Compulsive DisorderPhase 1NCT00073346
Pilot Trial of Cognitive and Behavioral Treatment of Compulsive Hoarding Compared to Wait List Control
A Phase 1 study testing Cognitive Behavioral Treatment in people with Obsessive-Compulsive Disorder, run by Boston University Charles River Campus at 2 sites in United States.
Trial summary
This study developed and tested a specialized cognitive and behavioral treatment for the symptoms of hoarding disorder, including excessive acquiring, difficulty discarding items, and extensive clutter in the home. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Cognitive Behavioral Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2003to 9 Jul 2008
- Phase
- Phase 1
- 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
- Display at least moderately severe hoarding symptoms
- Must live within 45 minutes of Boston, MA or Hartford, CT
Who cannot join
- Ten or more sessions of cognitive behavior therapy for hoarding
- Concurrent psychotherapy or medications
- Suicidal, psychotic, or other psychiatric symptoms requiring hospitalization
- Compulsive buying symptoms that are part of a manic phase of bipolar disorder
- Mental retardation, dementia, brain damage, or other cognitive dysfunction that would interfere with the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
BostonUCRC
Boston, Massachusetts, 02215
Hartford Hospital, Institute of Living
Hartford, Connecticut, 06106
About this study
Official title: Cognitive and Behavioral Treatment of Compulsive Hoarding
This study developed and tested a specialized cognitive and behavioral treatment for the symptoms of hoarding disorder, including excessive acquiring, difficulty discarding items, and extensive clutter in the home.
Read the detailed description
Compulsive hoarding is characterized by excessive acquisition of possessions, difficulty discarding possessions, and excessive clutter. This condition is resistant to standard pharmacological and psychotherapeutic interventions that have proven effective in treating other obsessive compulsive spectrum disorders. This study aimed to determine the effectiveness of a specialized cognitive behavioral therapy (CBT) designed for treating hoarding symptoms.
This study consists of three phases. In Phase 1, pilot data from previous studies were examined to develop an intervention suitable for use in a waitlist trial. In Phase 2, pilot study information were used to develop and test a treatment manual for compulsive hoarding. During this phase, treatment was applied flexibly to allow for variations in treatment duration and choice of techniques. During Phase 3, participants were randomly assigned to 26 weekly sessions of CBT or to a 12-week wait-list control, followed by active treatment for a fixed duration of 26 sessions. Therapist adherence and competence were assessed through audiotaped therapy sessions.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Cognitive Behavioral Treatment
- Keywords
- Hoarding Disorder
- Medical subject headings
- Obsessive-Compulsive Disorder, Hoarding Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TreatmentBehavioural
| Study group | Role | What they receive |
|---|---|---|
| cognitive behavior therapy for hoarding disorder | Experimental | Cognitive behavior therapy included 26 sessions of motivational enhancements; skills training for sorting, organizing and problem solving; direct practice not acquiring new items and discarding possessions to remove clutter and organize possessions; cognitive therapy to evaluate beliefs about possessions; and relapse prevention skills. Receives: Behavioral: Cognitive Behavioral Treatment |
| Wait list control | No intervention | Participants waited to receive treatment for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saving Inventory-Revised
Self-report questionnaire of hoarding severity; total score range = 0 to 92; higher values indicate more symptoms
Measured: change from baseline to week 12; change from baseline to week 26
Secondary outcomes (1)
Hoarding Rating Scale
Interviewer measure with 5 questions to assess hoarding severity; total score range = 0 to 40; higher values indicate more symptoms
Measured: change from baseline to week 12; change from baseline to week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2003 (estimated)
- Study start1 Sep 2003
- Primary completion1 Dec 2006
- Study completion9 Jul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- active treatment versus wait list control
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Gail Steketee, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00073346
- Sponsor's protocol ID
- R21MH068539
- Other IDs
- R21MH068539, DATR A2-AIA
- Status last verified
- Jan 2020
- First submitted
- 19 Nov 2003
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: De-identified data have been shared with investigators working on hoarding relevant projects such as assessment of hoarding and meta-analyses of treatment outcome for hoarding disorder. Sharing of de-identified data will be considered upon request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Behavioral Treatment of Compulsive Hoarding
- ClinicalTrials.gov ID
- NCT00073346
- Acronym / sponsor ID
- R21MH068539
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Hoarding Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Sep 2003 (actual)
- Primary completion
- 1 Dec 2006 (actual)
- Study completion
- 9 Jul 2008 (actual)
- First posted
- 21 Nov 2003 (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.
This study developed and tested a specialized cognitive and behavioral treatment for the symptoms of hoarding disorder, including excessive acquiring, difficulty discarding items, and extensive clutter in the home.
Detailed description
Compulsive hoarding is characterized by excessive acquisition of possessions, difficulty discarding possessions, and excessive clutter. This condition is resistant to standard pharmacological and psychotherapeutic interventions that have proven effective in treating other obsessive compulsive spectrum disorders. This study aimed to determine the effectiveness of a specialized cognitive behavioral therapy (CBT) designed for treating hoarding symptoms.
This study consists of three phases. In Phase 1, pilot data from previous studies were examined to develop an intervention suitable for use in a waitlist trial. In Phase 2, pilot study information were used to develop and test a treatment manual for compulsive hoarding. During this phase, treatment was applied flexibly to allow for variations in treatment duration and choice of techniques. During Phase 3, participants were randomly assigned to 26 weekly sessions of CBT or to a 12-week wait-list control, followed by active treatment for a fixed duration of 26 sessions. Therapist adherence and competence were assessed through audiotaped therapy sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- active treatment versus wait list control
| Arm | Type | Receives |
|---|---|---|
| cognitive behavior therapy for hoarding disorder | Experimental | Behavioral: Cognitive Behavioral TreatmentCognitive behavior therapy included 26 sessions of motivational enhancements; skills training for sorting, organizing and problem solving; direct practice not acquiring new items and discarding possessions to remove clutter and organize possessions; cognitive therapy to evaluate beliefs about possessions; and relapse prevention skills. |
| Wait list control | No intervention | –Participants waited to receive treatment for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Display at least moderately severe hoarding symptoms
- Must live within 45 minutes of Boston, MA or Hartford, CT
Key exclusion criteria (5 listed)
- Ten or more sessions of cognitive behavior therapy for hoarding
- Concurrent psychotherapy or medications
- Suicidal, psychotic, or other psychiatric symptoms requiring hospitalization
- Compulsive buying symptoms that are part of a manic phase of bipolar disorder
- Mental retardation, dementia, brain damage, or other cognitive dysfunction that would interfere with the study
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 Behavioral Treatment | Behavioural | cognitive behavior therapy for hoarding disorder |
Primary outcome
Saving Inventory-Revised
Time frame: change from baseline to week 12; change from baseline to week 26
Self-report questionnaire of hoarding severity; total score range = 0 to 92; higher values indicate more symptoms
1 secondary outcome
Hoarding Rating Scale
Time frame: change from baseline to week 12; change from baseline to week 26
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 21 Jan 2020.
- Click here for more information about compulsive hoarding.Link provided by the sponsor.
- Individual participant dataSharing planned: No. De-identified data have been shared with investigators working on hoarding relevant projects such as assessment of hoarding and meta-analyses of treatment outcome for hoarding disorder. Sharing of de-identified data will be considered upon request.
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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.
Gail Steketee principal investigator
Boston University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cognitive Behavioral Treatment in people with Obsessive-Compulsive Disorder, run by Boston University Charles River Campus at 2 sites in United States.
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 2 inclusion and 5 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 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (time frame: change from baseline to week 12; change from baseline to week 26). 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 21 Jan 2020.