An interventional study of Exercise Condition and Relaxation Control Condition in Hoarding Disorder, sponsored by Hartford Hospital. Not yet recruiting at 1 site in United States. Open to participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-20.
Sponsored by Hartford Hospital · Not applicable, Interventional, and Treatment
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.
32 studies on the registry are indexed under Hoarding Disorder; 5 are open to participants now.
This study's planned enrollment of 22 is below the median of 37 across 28 interventional studies indexed under Hoarding Disorder.
Browse Hoarding Disorder studies →Hartford Hospital is the lead sponsor of 105 studies on the registry; 20 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 5 (36%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Exercise Condition
For participants randomized to the control group, they will sit in the testing room and watch informational videos about animals.
Behavioral: Relaxation Control Condition
Already described in the arm description
Already described in the arm description
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).
Time frame: Immediately before and immediately after discarding task
Brain Derived Neurotropic Factor (BDNF)
Serum BDNF
Time frame: Immediately after the intervention or control condition
Number of items discarded
The number of items discarded vs. kept during the discarding task will be compared between conditions
Time frame: Experimenter will tally the number of items kept vs. discarded immediately after the discarding task
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2024; primary completion for Dec 2025, 14 months later.
Of 20 interventional studies with no phase under Hoarding Disorder, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 48. This study's planned 14 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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