Testing a Brief Exercise Intervention in Hoarding Disorder (Exercise BDNF)

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 Overview

• Status: Not yet recruiting
• Conditions: Hoarding Disorder
• Intervention / Treatment: Behavioral: Exercise Condition; Behavioral: Relaxation Control Condition

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hannah Levy, PhD; Phone Number: 860-545-7847; Email: hannah.levy@hhchealth.org

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Anxiety Disorders Center, Institute of Living
      • Contact: Hannah Levy, PhD; Phone Number: 860-545-7847; Email: hannah.levy@hhchealth.org
      • Principal Investigator: Hannah Levy, PhD
      • Sub-Investigator: David Tolin, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Exercise Condition; 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; Already described in the arm description
Other: Relaxation Control 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of items discarded	The number of items discarded vs. kept during the discarding task will be compared between conditions	Experimenter will tally the number of items kept vs. discarded immediately after the discarding task

Collaborators and Investigators

• Sponsor: Hartford Hospital
• Collaborators: University of Miami
• Investigators: Principal Investigator: Hannah Levy, PhD, Hartford Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Obsessive-Compulsive Disorder; Hoarding Disorder
• Other Study ID Numbers: Pending (Clinical Research Information Service)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No