NCT05237466

Brief Summary

This study will compare two behavioral interventions for hoarding disorder in older adults.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 14, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

3.1 years

First QC Date

January 14, 2022

Last Update Submit

November 18, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in frequency of sorting/discarding behavior

    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.

    Four months

  • Change in duration of sorting/discarding behavior

    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.

    Four months

  • Change in score on the University of Rhode Island Change Assessment Questionnaire McConnaughy et al., 1983)

    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).

    Four months

  • Change in score on the Apathy Evaluation Scale (AES-S; Marin, 1991)

    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).

    Four months

Secondary Outcomes (1)

  • Rating on the Treatment Acceptability/ Adherence Scale (TAAS; Milsevic et al., 2015)

    Immediately after session one

Other Outcomes (3)

  • Change in score on the Saving Inventory-Revised (SI-R; Frost et al., 2004)

    Four months

  • Change in score on the Clutter Image Rating (CIR; Frost et al., 2008)

    Four months

  • Change in scores on the Behavioral Approach Task for sorting/discarding(BAT; Dozier & Ayers, 2017; Dozier et al., 2020)

    Four months

Study Arms (2)

RECLAIM: Reducing Clutter and Increasing Meaning

EXPERIMENTAL

Participants will receive a combination of motivational interviewing and sorting practice to reduce hoarding symptoms.

Behavioral: RECLAIM: Reducing Clutter and Increasing Meaning

Sorting Practice

ACTIVE COMPARATOR

Participants will receive sorting practice only to reduce hoarding symptoms.

Behavioral: Sorting Practice

Interventions

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.

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. 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.

Sorting Practice

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mississippi State University

Starkville, Mississippi, 39762, United States

RECRUITING

MeSH Terms

Conditions

Hoarding Disorder

Condition Hierarchy (Ancestors)

Obsessive-Compulsive DisorderAnxiety DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 14, 2022

First Posted

February 14, 2022

Study Start

June 1, 2022

Primary Completion

July 1, 2025

Study Completion

October 1, 2025

Last Updated

November 20, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

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.

Locations