Hoarding DisorderExercise BDNFNCT06561659
Testing a Brief Exercise Intervention in Hoarding Disorder
A study testing Exercise Condition in people with Hoarding Disorder, run by Hartford Hospital at 1 site in United States.
Trial summary
Hoarding disorder (HD) is characterized by difficulty discarding personal possessions due to significant emotional distress when parting with personal items. This leads to the accumulation of excessive clutter which compromises the normal use of living spaces. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Hoarding Disorder
- What is being tested?
- Exercise Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2024to Dec 2025
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of hoarding disorder
- Age 45-65 years
Who cannot join
- Contraindications to engaging in exercise, including cardiovascular, metabolic, or renal disease, thyroid problems, uncontrolled hypertension
- Significant mobility issues that would preclude brisk walking
- Schizophrenia, bipolar disorder, serious suicidal risk, active substance use disorder, and cognitive impairment that may preclude the ability to provide informed consent and/or participate in study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Anxiety Disorders Center, Institute of Living
Hartford, Connecticut, 06106
Hannah Levy, PhD, 860-545-7847, hannah.levy@hhchealth.org
Hannah Levy, PhD
About this study
Hoarding disorder (HD) is characterized by difficulty discarding personal possessions due to significant emotional distress when parting with personal items. This leads to the accumulation of excessive clutter which compromises the normal use of living spaces. In addition to emotional distress, individuals with HD experience significant impairment in physical health. One study found an 11-fold increase in stroke risk, a 10-fold increase in cancer risk, and a 7-fold increase in cardiovascular disease in individuals with HD relative to a general population comparison group. Patients with HD are also more likely to experience obesity and metabolic diseases such as diabetes. The short-term goal of the proposed study is to determine whether a brief exercise intervention improves discarding-related distress and brain-derived neurotropic factor (BDNF) in individuals with HD relative to a relaxation control condition. Preliminary evidence suggests that BDNF may be associated with greater body mass index and more severe HD symptoms in patients with HD. BDNF is a well-studied growth factor which is involved in neuronal transmission, plasticity, and survival of many neuron systems that have been implicated in psychiatric disorders, including serotonin, glutamate, and dopamine. BDNF has been proposed as a mechanism of exercise interventions for psychiatric disorders, as even one session of exercise has been shown to increase BDNF levels. This study represents an initial first step towards the long-term goal of improving current treatments for HD. This is important because although current cognitive-behavioral treatments (CBT) are effective, only 35% of patients who receive these treatments actually benefit from them. In the proposed pilot study, the investigators will test whether 30 minutes of moderate-intensity exercise reduces the distress associated with discarding and increases BDNF levels in individuals with HD relative to a relaxation control. The investigators will recruit 22 individuals with a primary diagnosis of HD. They will be randomly assigned to exercise or control. Following the intervention, the investigators will assess BDNF via serum. Participants will complete a standardized discarding task which consists of sorting and discarding personal possessions. The central hypothesis is that those in the exercise condition will demonstrate lower distress during the discarding task and greater BDNF levels as compared to those in the relaxation control condition. Should the hypothesis be confirmed, the investigators will be well poised to conduct large-scale clinical trials testing exercise interventions as adjunctive or alternative treatments to standard CBT.
- Conditions
- Hoarding Disorder
- Being tested
- Exercise Condition, Relaxation Control Condition
- Medical subject headings
- Hoarding Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ConditionBehavioural
Already described in the arm description
Relaxation Control ConditionBehavioural
Already described in the arm description
| Study group | Role | What they receive |
|---|---|---|
| Exercise Condition | Active comparator | For participants randomized to the exercise intervention, they will complete 30 minutes of brisk walking around the campus. They will be asked to maintain at least a moderate level of exercise intensity throughout the 30-minute walk. Receives: Behavioral: Exercise Condition |
| Relaxation Control Condition | Other | For participants randomized to the control group, they will sit in the testing room and watch informational videos about animals. Receives: Behavioral: Relaxation Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Units of Distress Scale
Participants will be asked to rate their distress before and after the discarding task using the Subjective Units of Distress Scale (SUDS; 0 = no distress and 100 = worst distress imaginable).
Measured: Immediately before and immediately after discarding task
Brain Derived Neurotropic Factor (BDNF)
Serum BDNF
Measured: Immediately after the intervention or control condition
Secondary outcomes (1)
Number of items discarded
The number of items discarded vs. kept during the discarding task will be compared between conditions
Measured: Experimenter will tally the number of items kept vs. discarded immediately after the discarding task
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study startOct 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami
- Responsible party
- Principal investigator, Hannah Levy, Hartford Hospital
- Investigators
- Hannah Levy, PhD, Principal investigator, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561659
- Sponsor's protocol ID
- Pending
- Acronym
- Exercise BDNF
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Brief Exercise Intervention in Hoarding Disorder
- ClinicalTrials.gov ID
- NCT06561659
- Acronym / sponsor ID
- Exercise BDNF / Pending
- Conditions
- Hoarding Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Collaborators
- University of Miami
- Study start
- Oct 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 Aug 2024 (actual)
- 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.
Hoarding disorder (HD) is characterized by difficulty discarding personal possessions due to significant emotional distress when parting with personal items. This leads to the accumulation of excessive clutter which compromises the normal use of living spaces. In addition to emotional distress, individuals with HD experience significant impairment in physical health. One study found an 11-fold increase in stroke risk, a 10-fold increase in cancer risk, and a 7-fold increase in cardiovascular disease in individuals with HD relative to a general population comparison group. Patients with HD are also more likely to experience obesity and metabolic diseases such as diabetes. The short-term goal of the proposed study is to determine whether a brief exercise intervention improves discarding-related distress and brain-derived neurotropic factor (BDNF) in individuals with HD relative to a relaxation control condition. Preliminary evidence suggests that BDNF may be associated with greater body mass index and more severe HD symptoms in patients with HD. BDNF is a well-studied growth factor which is involved in neuronal transmission, plasticity, and survival of many neuron systems that have been implicated in psychiatric disorders, including serotonin, glutamate, and dopamine. BDNF has been proposed as a mechanism of exercise interventions for psychiatric disorders, as even one session of exercise has been shown to increase BDNF levels. This study represents an initial first step towards the long-term goal of improving current treatments for HD. This is important because although current cognitive-behavioral treatments (CBT) are effective, only 35% of patients who receive these treatments actually benefit from them. In the proposed pilot study, the investigators will test whether 30 minutes of moderate-intensity exercise reduces the distress associated with discarding and increases BDNF levels in individuals with HD relative to a relaxation control. The investigators will recruit 22 individuals with a primary diagnosis of HD. They will be randomly assigned to exercise or control. Following the intervention, the investigators will assess BDNF via serum. Participants will complete a standardized discarding task which consists of sorting and discarding personal possessions. The central hypothesis is that those in the exercise condition will demonstrate lower distress during the discarding task and greater BDNF levels as compared to those in the relaxation control condition. Should the hypothesis be confirmed, the investigators will be well poised to conduct large-scale clinical trials testing exercise interventions as adjunctive or alternative treatments to standard CBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Condition | Active comparator | Behavioral: Exercise ConditionFor participants randomized to the exercise intervention, they will complete 30 minutes of brisk walking around the campus. They will be asked to maintain at least a moderate level of exercise intensity throughout the 30-minute walk. |
| Relaxation Control Condition | Other | Behavioral: Relaxation Control ConditionFor participants randomized to the control group, they will sit in the testing room and watch informational videos about animals. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary diagnosis of hoarding disorder
- Age 45-65 years
Key exclusion criteria (3 listed)
- Contraindications to engaging in exercise, including cardiovascular, metabolic, or renal disease, thyroid problems, uncontrolled hypertension
- Significant mobility issues that would preclude brisk walking
- Schizophrenia, bipolar disorder, serious suicidal risk, active substance use disorder, and cognitive impairment that may preclude the ability to provide informed consent and/or participate in study procedures
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 |
|---|---|---|
| Exercise ConditionAlready described in the arm description | Behavioural | Exercise Condition |
| Relaxation Control ConditionAlready described in the arm description | Behavioural | Relaxation Control Condition |
Primary outcome
Subjective Units of Distress Scale
Time frame: Immediately before and immediately after discarding task
Participants will be asked to rate their distress before and after the discarding task using the Subjective Units of Distress Scale (SUDS; 0 = no distress and 100 = worst distress imaginable).
Brain Derived Neurotropic Factor (BDNF)
Time frame: Immediately after the intervention or control condition
Serum BDNF
1 secondary outcome
Number of items discarded
Time frame: Experimenter will tally the number of items kept vs. discarded immediately after the discarding task
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Hoarding Disorder
Not yet recruiting
A Test of Acceptance-based Bibliotherapy for Hoarding Disorder
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Self-Help Group for the Treatment of Hoarding Disorder
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Neural Mechanisms of Decision Making in Hoarding Disorder
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Rapid Non-Invasive Brain Stimulation for Hoarding Disorder
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Recruiting
Detection of Hoarding Disorder and Related Psychopathology
Hoarding Disorder, Hoarding
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.
Hannah Levy, PhD principal investigator
Hartford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Condition in people with Hoarding Disorder, run by Hartford Hospital at 1 site 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 3 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: status not confirmed, as of the sponsor's last update on 20 Aug 2024. 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 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hannah Levy, PhD (860-545-7847, hannah.levy@hhchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Units of Distress Scale (time frame: Immediately before and immediately after discarding task). The study lists 2 primary outcomes in all. 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 20 Aug 2024.