Motivational Interviewing to Enhance Behavioral Change in Older Adults With Hoarding Disorder

• ClinicalTrials.gov Identifier: NCT05237466
• Recruitment Status: Recruiting
• First Posted: February 14, 2022
• Last Update Posted: October 19, 2023
• Sponsor: Mississippi State University
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Mary Dozier, Mississippi State University

Tracking Information

• First Submitted Date: January 14, 2022
• First Posted Date: February 14, 2022
• Last Update Posted Date: October 19, 2023
• Actual Study Start Date: June 1, 2022
• Estimated Primary Completion Date: February 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 2, 2022)

• Change in frequency of sorting/discarding behavior [ Time Frame: Four months ]
  As a behavioral indicator of motivation to engage in sorting/discarding behavior, participants will be asked to report at baseline and at their weekly treatment sessions the frequency of sorting/discarding items in the previous week.
• Change in duration of sorting/discarding behavior [ Time Frame: Four months ]
  As a behavioral indicator of motivation to engage in sorting/discarding behavior, participants will be asked to report at baseline and at their weekly treatment sessions the duration of sorting/discarding items in the previous week.
• Change in score on the University of Rhode Island Change Assessment Questionnaire McConnaughy et al., 1983) [ Time Frame: Four months ]
  The URICA is a 32-item Likert scale that assesses readiness for change and includes four subscales that individually assess stage of change (Precontemplation, Contemplation, Action, and Maintenance). Previous investigations have found adequate internal reliability for the URICA in treatment-seeking samples (Dozois et al., 2004), including in older hoarding samples specifically (Ayers et al., 2019).
• Change in score on the Apathy Evaluation Scale (AES-S; Marin, 1991) [ Time Frame: Four months ]
  The AES is an 18-item measure of an individual's deficits in goal-directed thoughts and behavior. The AES was developed specifically to assess apathy in adults aged 55+ and is predictive of motivation for behavioral change (Resnick et al., 2012).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 2, 2022)

Rating on the Treatment Acceptability/ Adherence Scale (TAAS; Milsevic et al., 2015) [ Time Frame: Immediately after session one ]

The TAAS is a 10-item self-report measure of a patient's perception of the acceptability of a treatment as well as their anticipated adherence to the protocol.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: February 2, 2022)

• Change in score on the Saving Inventory-Revised (SI-R; Frost et al., 2004) [ Time Frame: Four months ]
  The SI-R is a 23-item measure of the three core hoarding symptoms (urges to save, difficulty discarding, and excessive clutter).
• Change in score on the Clutter Image Rating (CIR; Frost et al., 2008) [ Time Frame: Four months ]
  The CIR is a three-item pictorial rating scale of clutter level in the bedroom, kitchen, and living room. Assessor ratings of the CIR will be used for the proposed project.
• Change in scores on the Behavioral Approach Task for sorting/discarding(BAT; Dozier & Ayers, 2017; Dozier et al., 2020) [ Time Frame: Four months ]
  The BAT involves the participant sorting items in a cluttered part of their home for 15 minutes. The speed of sorting and percentage of items discarded will be used as behavioral indicators of hoarding severity.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Motivational Interviewing to Enhance Behavioral Change in Older Adults With Hoarding Disorder
• Official Title: Motivational Interviewing to Enhance Behavioral Change in Older Adults With Hoarding Disorder
• Brief Summary: This study will compare two behavioral interventions for hoarding disorder in older adults.

Detailed Description

Hoarding disorder is a psychological condition with a unique constellation of consequences for older adults, including increased risk of fire and dying in a fire, insect infestation, and medical problems. Dangers related to cluttered living spaces are exacerbated by reduced executive functioning, attention, and concentration. Hoarding psychopathology results from maladaptive cognitions (e.g., desire to keep items others would discard) and maladaptive behavioral patterns (e.g., avoidance of sorting/discarding items).

Extant treatments for hoarding have targeted fear reduction as the mechanism of change, either through cognitive-behavioral therapy focusing on cognitive restructuring or behavior therapy focusing on exposure therapy. Older adults have a lackluster response to cognitive restructuring for hoarding, and, although exposure therapy increases treatment response, both approaches require a lengthy six-month dose. Our preliminary work suggests that fear reduction may not be a universally relevant target mechanism for older adults, and that to be responsive to the specific needs of older adults, other mechanisms need to be identified.

Motivational interviewing is a technique that is already typically incorporated into hoarding treatment and has been demonstrated to increase motivation for behavioral change across a range of health conditions for older adults, including physical activity, diet, and disease management. Because sorting/discarding is at its core a health behavior that hoarding patients lack the motivation to engage in, motivational interviewing is likely to decrease hoarding severity by eliciting increased levels of sorting/discarding.

The proposed project will use a mechanistic clinical trials approach to determine if a four-month intervention combining motivational interviewing with sorting practice can engage the proposed target, motivation for behavioral change, when compared to a four-month dose of sorting practice alone in a sample of rural-dwelling older adults with hoarding disorder.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Hoarding Disorder

Intervention

• Behavioral: RECLAIM: Reducing Clutter and Increasing Meaning
  Participants will receive 16 weekly 1-hour treatment sessions in their home delivered by Masters-level clinicians with the assistance of undergraduate researchers. Each treatment session will involve a combination of motivational interviewing (MI) and sorting practice. The rationale behind the sorting practice is to develop the skill of sorting and the formation of a daily sorting routine. The MI portion of the initial session will involve an evaluation of client strengths and individual biopsychosocial goals. The initial and subsequent sessions will include a variety of MI techniques, including decisional balancing, developing discrepancy, personalized feedback, and reinforcement of responsibility of sense of self-efficacy.
• Behavioral: Sorting Practice
  Participants will receive 16 weekly 1-hour treatment sessions in their home delivered by Masters-level clinicians with the assistance of undergraduate researchers. Clinicians will encourage participants to sort objects during each session while refraining from use of any specific cognitive or motivational therapeutic techniques. Participants will be asked to record the frequency and duration of any sorting/ discarding they did during the previous week.

Study Arms

• Experimental: RECLAIM: Reducing Clutter and Increasing Meaning
  Participants will receive a combination of motivational interviewing and sorting practice to reduce hoarding symptoms.
  Intervention: Behavioral: RECLAIM: Reducing Clutter and Increasing Meaning
• Active Comparator: Sorting Practice
  Participants will receive sorting practice only to reduce hoarding symptoms.
  Intervention: Behavioral: Sorting Practice

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 2, 2022): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2025
• Estimated Primary Completion Date: February 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Aged 60+
• Live within a 60-minute driving radius of Starkville, MS
• Have a primary psychiatric diagnosis of hoarding disorder

Exclusion Criteria:

• Major cognitive impairment
• Active psychosis, drug use, or acute suicidal ideation
• Concurrent psychotherapy focused on hoarding
• Changed psychotropic medications within the past three months

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Mary E Dozier, Ph.D.; (662) 325-0523; maryedozier@psychology.msstate.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05237466
• Other Study ID Numbers: 21-561; 1R15MH127565-01A1 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: All data collected will be shared using the NIMH Data Archive (NDA) following safe harbor requirements for de-identification. Data dictionaries currently available in NDA will be used for most measures assessed (e.g., PROMIS measures), but new data dictionaries will be created for unique data elements (e.g., reported frequency of sorting behavior) and standardized measures not currently entered in the NDA (e.g., Clutter Image Rating). Data will be deposited in the NDA twice per year over the course of the study and once the study is complete. Each manuscript based off the study will have specific analytic files deposited to the NDA once the manuscript is accepted for publication.

• Current Responsible Party: Mary Dozier, Mississippi State University
• Original Responsible Party: Same as current
• Current Study Sponsor: Mississippi State University
• Original Study Sponsor: Same as current
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Not Provided
• PRS Account: Mississippi State University
• Verification Date: October 2023