Testing a Brief Exercise Intervention in Hoarding Disorder

NCT06561659 | Not Yet Recruiting

• 1 other identifier: Pending
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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).

  Immediately before and immediately after discarding task

• Brain Derived Neurotropic Factor (BDNF)

  Serum BDNF

  Immediately after the intervention or control condition

Secondary Outcomes (1)

• Number of items discarded

  Experimenter will tally the number of items kept vs. discarded immediately after the discarding task

Study Arms (2)

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.

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.

Behavioral: Relaxation Control Condition

Interventions

Exercise Condition BEHAVIORAL

Already described in the arm description

Exercise Condition

Relaxation Control Condition BEHAVIORAL

Already described in the arm description

Relaxation Control Condition

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary diagnosis of hoarding disorder
• Age 45-65 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Hartford Hospital: lead
• University of Miami: collaborator

Study Sites (1)

Anxiety Disorders Center, Institute of Living

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

Hoarding Disorder

Condition Hierarchy (Ancestors)

Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders

Study Officials

• Hannah Levy, PhD

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah Levy, PhD

CONTACT

860-545-7847; hannah.levy@hhchealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants and investigators will not know the condition assignment until the intervention is about to begin. So the informed consent process, the study eligibility interview, and the self-report measures will be completed prior to condition assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Psychologist

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 20, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)