ClinicalTrials.gg
CompletedNCT02402647CRESTUpdated Sep 19, 2024Results posted

Cognitive Rehab and Exposure Treatment for Hoarding

An interventional study of Cognitive Rehabilitation and Exposure/Sorting Treatment (CREST) and Exposure Therapy (ET) in Hoarding Disorder, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
115
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

This project will utilize a novel behavioral intervention for hoarding disorder that takes into account age and neurocognitive factors. The goal of this project is to gain knowledge on how treatment components may or may not work for Veterans with hoarding disorder. Further, the investigators hope to increase understanding of functional and long term outcomes in response to hoarding treatment.

Read the detailed description

Objective: The investigators propose to conduct a randomized controlled trial comparing six months (26 sessions) of Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) treatment to a robust comparator, six months of Exposure Therapy alone, in 136 participants with HD.

Research Design: Assessments will be administered at baseline, during treatment (sessions 7, 13, 21), post-treatment, and 3- and 6-month follow-up, thus, all participants will be enrolled for one year.

Methodology: The primary objective is to evaluate whether CREST significantly reduces hoarding symptoms and improves functional capacity and quality of life when compared to exposure therapy alone. The investigators will also examine the impact of treatment mediators; treatment adherence, changes in executive functioning, avoidance, symptom severity on outcomes. Age and executive functioning will also be explored as potential moderators. Finally, by repeatedly measuring treatment targets, the investigators will examine time to maximum treatment effect in an effort to understand mechanisms of change.

Clinical Relationships: By providing a treatment for many Veterans with HD, the investigators can alter the course of their symptom trajectory and negative consequences, resulting in both healthcare costs savings and improved quality of life for Veterans.

02

Conditions studied

  • Hoarding Disorder

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Keywords

  • Hoarding
  • Compulsive Hoarding
03

In context

Hoarding Disorder

32 studies on the registry are indexed under Hoarding Disorder; 5 are open to participants now.

This study's enrollment of 115 is above the median of 27 across 28 interventional studies indexed under Hoarding Disorder.

Browse Hoarding Disorder studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,768 studies on the registry; 393 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 183 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Veterans age 18-85
  • Hoarding Disorder diagnosis outlined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)6 as measured by the Structured Interview for Hoarding Disorder (SIHD)67
  • HD as a primary diagnosis
  • Stable on medications for at least 12 weeks, with no pharmacologic changes expected or made during the 12-month study
  • Voluntary consent to participate

Exclusion criteria

Exclusion Criteria:

  • Diagnosis of:

    • psychotic disorder
    • substance abuse disorder as measured by the Mini-International Neuropsychiatric Interview (M.I.N.I.)68
  • Current or history of any neurodegenerative disease
  • Active suicidal ideation
  • Concurrent participation in psychotherapy or ET for HD, or prior history of CREST for HD
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
115 participants (actual)

Study arms

  • Experimental
    Cognitive Rehabilitation and Exposure/Sorting Treatment (CREST)

    Compensatory Cognitive Training (CCT) is a manualized, low-tech, cognitive training intervention designed to target cognitive impairments common in people with psychiatric illness. The CCT modules specifically selected for CREST map onto known areas of HD neurocognitive deficits or weakness and include training in prospective memory, prioritizing, problem solving, planning, and cognitive flexibility. Symptoms of acquiring and saving are themselves avoidance behaviors that are performed to avoid internal distress related to negative thoughts and emotions. Avoidance serves to reduce distress related to the beliefs regarding the necessity and utility of possessions. In the CREST condition, the second part and the majority of treatment is dedicated to exposure therapy (ET) for discarding and not acquiring while in the control condition, the entire treatment will consist of ET.

    Behavioral: Cognitive Rehabilitation and Exposure/Sorting Treatment (CREST)

  • Active comparator
    Exposure Therapy (ET)

    The investigators propose to use a robust control condition, exposure therapy (ET), with the same frequency and amount of therapist contact as CREST. Twenty-six weekly, individual ET sessions (6 months) will be delivered. The control group will receive ET for all 26 sessions and no cognitive training. As in CREST, the ET sessions will be manualized and copies utilized during session by both the patient and therapist.

    Behavioral: Exposure Therapy (ET)

Interventions

  • BehavioralCognitive Rehabilitation and Exposure/Sorting Treatment (CREST)

    Compensatory Cognitive Training is a manualized, low-tech, cognitive training intervention designed to target cognitive impairments common in people with psychiatric illness. The CCT modules specifically selected for CREST map onto known areas of HD neurocognitive deficits or weakness and include training in prospective memory, prioritizing, problem solving, planning, and cognitive flexibility. Symptoms of acquiring and saving are themselves avoidance behaviors that are performed to avoid internal distress related to negative thoughts and emotions. Avoidance serves to reduce distress related to the beliefs regarding the necessity and utility of possessions. In the CREST condition, the second part and the majority of treatment is dedicated to exposure therapy (ET) for discarding and not acquiring while in the control condition, the entire treatment will consist of ET.

  • BehavioralExposure Therapy (ET)

    The investigators propose to use a robust control condition, ET, with the same frequency and amount of therapist contact as CREST. Twenty-six weekly, individual ET sessions (6 months) will be delivered. The control group will receive ET for all 26 sessions and no cognitive training. As in CREST, the ET sessions will be manualized and copies utilized during session by both the patient and therapist.

06

What researchers measure

Primary outcomes

  1. Saving Inventory Revised

    Hoarding symptom severity (primary outcome) will be measured using the Savings Inventory-Revised (SI-R)56, a 23-item self-report measure used to assess common hoarding symptoms. Subscales include clutter, acquisition, and difficulty discarding. The SI-R has demonstrated good internal consistency, divergent validity, concurrent validity, and test-retest reliability in clinical samples with hoarding. The total score will be used for analyses. Total of 23 items divided into 3 subscales, each item Likert scale ranges from 0-4 (0= not at all, 4= extreme), Clutter Subscale (9 items): scores greater than 13 indicate clinical significance (Max score=36), Difficulty Discarding/Saving Subscale (7 items): scores greater than 13 indicate clinical significance, Acquisition Subscale (7 items): scores greater than 15 indicate clinical significance (Max Score= 28). Total Max score = 92. A Total score greater than 40 is a typical score for people experiencing challenges with hoarding behaviors.

    Time frame: Baseline to 6 month-follow-up (12 months total)

Secondary outcomes

  1. UCSD Performance-Based Skills Assessment (UPSA)

    The University of California San Diego (UCSD) Performance-Based Skills Assessment (UPSA)76 is an assessment of everyday functioning skills including household skills (e.g., writing a shopping list based on a recipe, range 0 to 4), communication (e.g., rescheduling appointments, range 0 to 12), finance (e.g., paying a utility bill, range 0 to 11), comprehension and planning (e.g., planning outings, range 0 to 14), and transportation (e.g., comprehension of a bus schedule, range 0 to 9). The subscales are scored, converted to a percentage, and weighed equally toward the total score of 100; higher score equals better performance for all subscales and total. The UPSA has demonstrated high inter-rater reliability (0.91) and convergent validity with other performance-based measures. The total UPSA summary score will be used for analyses. \*Nearly half of each timepoint was out of 60 due to adjustments for COVID-19, a total of 60 was used with financial, communication, and planning subscales.

    Time frame: Baseline to 6 months post-treatment (on average 1 year)

  2. UCSD SORT Test

    The UCSD SORT Test (U-SORT) is a cognitive test that will be used to measure Veteran participants' organizational skills as they relate to functional capacity. During the administration of the U-SORT, participants are instructed to sort 42 household objects (e.g., bent and unbent paper clips, used and unused condiment packets) from a hypothetical "junk drawer" into either "keep" or "trash" piles. Each item has a correct response and participants are given two minutes to complete the task and one point is awarded for each correctly sorted item, for a total of 42 points (range of 0 to 42). A higher total score indicates a higher level of organizational skills. The U-SORT has high internal consistency (? = .86) and adequate convergent validity. The total U-SORT score will be used in analyses.

    Time frame: Baseline to 6 months post-treatment

  3. Specific Levels of Functioning Test (SLOF)

    Self-reported functioning (secondary outcome) will be assessed with the Specific Levels of Functioning test (SLOF)78, a 43-item Likert scale questionnaire with higher scores indicating higher levels of functioning. Subscales include interpersonal relationships (score range of 7 to 35), social acceptability (score range of 6 to 30), participation in activities (score range of 11 to 55), and work skills (score range of 6 to 30). Total of 30 items across four categories and each item ranges from the scale of 1-5 (higher values= better outcomes). Category A. Interpersonal Relationships (items 1-7): 5= Highly Typical, 1= Highly Untypical. Category B. Social Acceptability (items 8-13): 5= Never, 1= Always. Category C. Activities (items 14-24): 5= Totally Self Sufficient, 1= No Opportunity to perform. Category D. Work Skills (items 25-30): 5= Highly Typical, 1= Highly Untypical. Total Max Score Range= 30-150).The SLOF has demonstrated excellent reliability and internal consistency.

    Time frame: Baseline to 6 months post-treatment

07

Results

Posted Sep 19, 2024
Limitations and caveats
The addition of motivational interviewing techniques prior to study initiation greatly reduced drop outs. Further, the last half of the study employed licensed clinicians. Finally, due to COVID-19, the study was shut down for several months while we transitioned to all virtual care. During that time, we lost participants to follow-up and those who preferred in person care only.

Participant flow

Participant flow — Overall Study
MilestoneCRESTExposure Therapy
Started5956
Completed3442
Not completed2514
Withdrew: Lost to follow-up137
Withdrew: Protocol violation11
Withdrew: Scheduled and timed out21
Withdrew: Medical illness24
Withdrew: Moved20
Withdrew: Loved one illness10
Withdrew: Deceased preexisting condition20
Withdrew: Other21

Outcome measures

PrimarySaving Inventory Revised

Hoarding symptom severity (primary outcome) will be measured using the Savings Inventory-Revised (SI-R)56, a 23-item self-report measure used to assess common hoarding symptoms. Subscales include clutter, acquisition, and difficulty discarding. The SI-R has demonstrated good internal consistency, divergent validity, concurrent validity, and test-retest reliability in clinical samples with hoarding. The total score will be used for analyses. Total of 23 items divided into 3 subscales, each item Likert scale ranges from 0-4 (0= not at all, 4= extreme), Clutter Subscale (9 items): scores greater than 13 indicate clinical significance (Max score=36), Difficulty Discarding/Saving Subscale (7 items): scores greater than 13 indicate clinical significance, Acquisition Subscale (7 items): scores greater than 15 indicate clinical significance (Max Score= 28). Total Max score = 92. A Total score greater than 40 is a typical score for people experiencing challenges with hoarding behaviors.

Time frame:
Baseline to 6 month-follow-up (12 months total)
Reported as:
Mean · score on a scale
Saving Inventory Revised
score on a scaleCRESTExposure Therapy
Baseline SI-R:59.9 ± 15.855.3 ± 14.8
Baseline SI-R: Clutter Subcategory25.2 ± 7.723.0 ± 8.2
Baseline SI-R: Acquisition Subcategory16.6 ± 5.514.4 ± 5.4
Baseline SI-R: Discarding Subcategory18.1 ± 5.517.9 ± 5.1
Timepoint 1 (S7) SI-R51.6 ± 16.850.5 ± 16.4
Timepoint 1 (S7) SI-R: Clutter Subcategory22.6 ± 8.421.7 ± 8.0
Timepoint 1 (S7) SI-R: Acquisition Subcategory14.1 ± 5.812.9 ± 6.1
Timepoint 1 (S7) SI-R: Discarding Subcategory14.9 ± 5.215.9 ± 5.0
Timepoint 2 (S13) SI-R:47.3 ± 17.745.5 ± 16.9
Timepoint 2 (S13) SI-R: Clutter Subcategory20.1 ± 8.719.6 ± 8.5
Timepoint 2 (S13) SI-R: Acquisition Subcategory13.1 ± 6.311.5 ± 6.0
Timepoint 2 (S13) SI-R: Discarding Subcategory14.2 ± 5.514.4 ± 5.1
Timepoint 3 (S21) SI-R:45.0 ± 18.941.1 ± 17.3
Timepoint 3 (S21) SI-R: Clutter Subcategory19.8 ± 8.318.1 ± 7.6
Timepoint 3 (S21) SI-R: Acquisition Subcategory11.7 ± 6.29.3 ± 5.7
Timepoint 3 (S21) SI-R: Discarding Subcategory13.5 ± 7.013.8 ± 5.7
Post-Treatment SI-R:37 ± 19.629.9 ± 18.6
Post-Treatment SI-R: Clutter Subcategory16.1 ± 9.412.9 ± 8.8
Post-Treatment SI-R: Acquisition Subcategory10.0 ± 6.17.3 ± 5.9
Post-Treatment SI-R: Discarding Subcategory10.9 ± 6.49.8 ± 5.8
3 month post-treatment SI-R:37.5 ± 21.432.6 ± 20.4
3 month post-treatment SI-R: Clutter Subcategory16.2 ± 10.514.5 ± 8.9
3 month post-treatment SI-R: Acquisition Subcategory9.9 ± 6.57.9 ± 6.3
3 month post-treatment SI-R: Discarding Subcategory11.3 ± 7.310.2 ± 6.4
6 month post-treatment SI-R:34.3 ± 18.128.9 ± 18.9
6 month post-treatment SI-R: Clutter Subcategory15.2 ± 9.312.2 ± 9.0
6 month post-treatment SI-R: Acquisition Subcategory8.7 ± 5.26.7 ± 5.7
6 month post-treatment SI-R: Discarding Subcategory10.3 ± 6.79.9 ± 5.8
SecondaryUCSD Performance-Based Skills Assessment (UPSA)

The University of California San Diego (UCSD) Performance-Based Skills Assessment (UPSA)76 is an assessment of everyday functioning skills including household skills (e.g., writing a shopping list based on a recipe, range 0 to 4), communication (e.g., rescheduling appointments, range 0 to 12), finance (e.g., paying a utility bill, range 0 to 11), comprehension and planning (e.g., planning outings, range 0 to 14), and transportation (e.g., comprehension of a bus schedule, range 0 to 9). The subscales are scored, converted to a percentage, and weighed equally toward the total score of 100; higher score equals better performance for all subscales and total. The UPSA has demonstrated high inter-rater reliability (0.91) and convergent validity with other performance-based measures. The total UPSA summary score will be used for analyses. \*Nearly half of each timepoint was out of 60 due to adjustments for COVID-19, a total of 60 was used with financial, communication, and planning subscales.

Time frame:
Baseline to 6 months post-treatment (on average 1 year)
Reported as:
Mean · score on a scale
UCSD Performance-Based Skills Assessment (UPSA)
score on a scaleCRESTExposure Therapy
Baseline UPSA49.0 ± 7.449.1 ± 6.8
Baseline UPSA: Financial Subcategory18.3 ± 2.518.0 ± 2.2
Baseline UPSA: Communication Subcategory16.2 ± 2.615.3 ± 3.1
Baseline UPSA: Comprehension/Planning Subcategory14.5 ± 5.215.8 ± 4.2
Baseline UPSA: Transportation Subcategory16.2 ± 2.815.9 ± 3.8
Baseline UPSA: Household Skills Subcategory17.6 ± 3.718.5 ± 2.3
Timepoint 1 (S7) UPSA50.3 ± 8.350.9 ± 6.4
Timepoint 1 (S7) UPSA: Financial Subcategory18.8 ± 1.518.3 ± 2.3
Timepoint 1 (S7) UPSA: Communication Subcategory15.9 ± 3.016.6 ± 2.0
Timepoint 1 (S7) UPSA: Comprehension/Planning Subcategory16.4 ± 3.516.0 ± 4.6
Timepoint 1 (S7) UPSA: Transportation Subcategory15.9 ± 2.716.6 ± 2.9
Timepoint 1 (S7) UPSA: Household Skills Subcategory18.3 ± 2.718.0 ± 2.8
Timepoint 2 (S13) UPSA52.7 ± 4.052.7 ± 5.2
Timepoint 2 (S13) UPSA: Financial Subcategory18.6 ± 1.71.1 ± 2.5
Timepoint 2 (S13) UPSA: Communication Subcategory16.7 ± 2.416.8 ± 2.4
Timepoint 2 (S13) UPSA: Comprehension/Planning Subcategory17.4 ± 3.217.8 ± 3.2
Timepoint 2 (S13) UPSA: Transportation Subcategory16.0 ± 2.516.8 ± 2.6
Timepoint 2 (S13) UPSA: Household Skills Subcategory17.1 ± 4.017.6 ± 2.9
Timepoint 3 (S21) UPSA52.7 ± 4.052.7 ± 5.2
Timepoint 3 (S21) UPSA: Financial Subcategory18.6 ± 1.718.1 ± 2.5
Timepoint 3 (S21) UPSA: Communication Subcategory16.7 ± 2.416.8 ± 2.4
Timepoint 3 (S21) UPSA: Comprehension/Planning Subcategory17.4 ± 3.217.8 ± 3.2
Timepoint 3 (S21) UPSA: Transportation Subcategory16.0 ± 2.516.8 ± 2.6
Timepoint 3 (S21) UPSA: Household Skills Subcategory17.1 ± 4.017.6 ± 2.9
Post Treatment UPSA51.8 ± 7.254.6 ± 5.2
Post Treatment UPSA: Financial Subcategory18.3 ± 2.418.9 ± 1.7
Post Treatment UPSA: Communication Subcategory16.3 ± 3.017.8 ± 1.7
Post Treatment UPSA: Comprehension/Planning Subcategory17.2 ± 4.617.9 ± 3.4
Post Treatment UPSA: Transportation Subcategory16.8 ± 2.117.0 ± 2.4
Post Treatment UPSA: Household Skills Subcategory17.3 ± 4.218.3 ± 2.4
3 month Follow Up UPSA54.1 ± 4.554.0 ± 3.3
3 month Follow Up UPSA: Financial Subcategory18.6 ± 2.118.8 ± 1.3
3 month Follow Up UPSA: Communication Subcategory16.6 ± 2.717.2 ± 1.8
3 month Follow Up UPSA: Comprehension/Planning Subcategory18.9 ± 1.918.7 ± 2.6
3 month Follow Up UPSA: Transportation Subcategory15.2 ± 6.517.4 ± 2.7
3 month Follow Up UPSA: Household Skills Subcategory15.6 ± 6.816.6 ± 5.3
6 month Follow Up UPSA:52.5 ± 7.453.8 ± 5.0
6 month Follow Up UPSA: Financial Subcategory19.1 ± 1.418.9 ± 1.4
6 month Follow Up UPSA: Communication Subcategory15.8 ± 4.117.3 ± 2.7
6 month Follow Up UPSA: Comprehension/Planning Subcategory17.5 ± 4.317.6 ± 3.0
6 month Follow Up UPSA: Transportation Subcategory14.0 ± 6.518.0 ± 2.3
6 month Follow Up UPSA: Household Skills Subcategory20.0 ± 0.017.6 ± 3.1
SecondaryUCSD SORT Test

The UCSD SORT Test (U-SORT) is a cognitive test that will be used to measure Veteran participants' organizational skills as they relate to functional capacity. During the administration of the U-SORT, participants are instructed to sort 42 household objects (e.g., bent and unbent paper clips, used and unused condiment packets) from a hypothetical "junk drawer" into either "keep" or "trash" piles. Each item has a correct response and participants are given two minutes to complete the task and one point is awarded for each correctly sorted item, for a total of 42 points (range of 0 to 42). A higher total score indicates a higher level of organizational skills. The U-SORT has high internal consistency (? = .86) and adequate convergent validity. The total U-SORT score will be used in analyses.

Time frame:
Baseline to 6 months post-treatment
Reported as:
Mean · score on a scale
UCSD SORT Test
score on a scaleCognitive Rehabilitation and Exposure/Sorting TherapyExposure Therapy
Baseline USORT33.1 ± 3.931.2 ± 4.7
Timepoint 1 (S7) USORT32.5 ± 5.032.7 ± 5.3
Timepoint 2 (S13) USORT34.2 ± 4.134.2 ± 4.2
Timepoint 3 (S21) USORT33.2 ± 6.132.9 ± 4.4
Post-Treatment USORT34.5 ± 3.432.3 ± 5.2
3 month Post-Treatment USORT36.1 ± 4.031.4 ± 6.9
6 month Post-Treatment USORT35.9 ± 2.934.0 ± 5.2
SecondarySpecific Levels of Functioning Test (SLOF)

Self-reported functioning (secondary outcome) will be assessed with the Specific Levels of Functioning test (SLOF)78, a 43-item Likert scale questionnaire with higher scores indicating higher levels of functioning. Subscales include interpersonal relationships (score range of 7 to 35), social acceptability (score range of 6 to 30), participation in activities (score range of 11 to 55), and work skills (score range of 6 to 30). Total of 30 items across four categories and each item ranges from the scale of 1-5 (higher values= better outcomes). Category A. Interpersonal Relationships (items 1-7): 5= Highly Typical, 1= Highly Untypical. Category B. Social Acceptability (items 8-13): 5= Never, 1= Always. Category C. Activities (items 14-24): 5= Totally Self Sufficient, 1= No Opportunity to perform. Category D. Work Skills (items 25-30): 5= Highly Typical, 1= Highly Untypical. Total Max Score Range= 30-150).The SLOF has demonstrated excellent reliability and internal consistency.

Time frame:
Baseline to 6 months post-treatment
Reported as:
Mean · score on a scale
Specific Levels of Functioning Test (SLOF)
score on a scaleCRESTExposure Therapy
Baseline SLOF Overall123.9 ± 12.9128.0 ± 15.0
Baseline Interpersonal Relationships Subscale25.6 ± 6.224.7 ± 7.0
Baseline Social Acceptability Subscale26.6 ± 2.526.7 ± 2.5
Baseline Activities Subscale50.7 ± 4.851.8 ± 5.7
Baseline Work Skills Subscale24.5 ± 4.925.2 ± 4.9
Timepoint 1 (S7) SLOF Overall127.0 ± 15.2128.1 ± 13.9
Timepoint 1 (S7) Interpersonal Relationships Subscale23.1 ± 6.724.4 ± 7.0
Timepoint 1 (S7) Social Acceptability Subscale26.8 ± 2.727.4 ± 2.0
Timepoint 1 (S7) Activities Subscale52.1 ± 4.452.2 ± 4.3
Timepoint 1 (S7) Work Skills Subscale25.0 ± 4.924.2 ± 5.2
Timepoint 2 (S13) SLOF Overall128.5 ± 14.6126.0 ± 15.0
Timepoint 2 (S13) Interpersonal Relationships Subscale23.8 ± 6.423.4 ± 6.5
Timepoint 2 (S13) Social Acceptability Subscale27.5 ± 2.327.0 ± 2.0
Timepoint 2 (S13) Activities Subscale52.3 ± 5.251.9 ± 5.3
Timepoint 2 (S13) Work Skills Subscale25.0 ± 4.723.6 ± 5.8
Timepoint 3 (S21) SLOF Overall128.3 ± 14.5125.4 ± 14.8
Timepoint 3 (S21) Interpersonal Relationships Subscale24.4 ± 6.723.7 ± 6.8
Timepoint 3 (S21) Social Acceptability Subscale26.6 ± 4.627.2 ± 2.1
Timepoint 3 (S21) Activities Subscale51.7 ± 4.951.3 ± 5.2
Timepoint 3 (S21) Work Skills Subscale25.6 ± 3.823.3 ± 5.3
Post-Treatment SLOF Overall131.9 ± 15.4124.6 ± 15.9
Post-Treatment Interpersonal Relationships Subscale25.3 ± 7.123.2 ± 7.0
Post-Treatment Social Acceptability Subscale28.0 ± 2.027.2 ± 2.3
Post-Treatment Activities Subscale51.8 ± 8.351.3 ± 5.3
Post-Treatment Work Skills Subscale26.8 ± 3.722.9 ± 5.9
3 month Follow Up SLOF Overall133.9 ± 11.9125.6 ± 16.8
3 month Follow Up Interpersonal Relationships Subscale25.6 ± 7.423.8 ± 6.9
3 month Follow Up Social Acceptability Subscale28.0 ± 1.827.1 ± 2.4
3 month Follow Up Activities Subscale53.7 ± 3.751.6 ± 5.3
3 month Follow Up Work Skills Subscale26.6 ± 3.923.1 ± 6.3
6 month Follow Up SLOF Overall133.2 ± 13.6124.0 ± 20.0
6 month Follow Up Interpersonal Relationships Subscale25.8 ± 7.024.6 ± 6.5
6 month Follow Up Social Acceptability Subscale27.6 ± 2.227.7 ± 1.9
6 month Follow Up Activities Subscale54.4 ± 1.850.9 ± 6.5
6 month Follow Up Work Skills Subscale26.8 ± 4.023.5 ± 7.0

Adverse events

Collected over Baseline assessment throughout intervention completion (approximately 6-months) and throughout follow-up period (another 6 months) for a total of approximately 1 year.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cognitive Rehabilitation and Exposure/Sorting Therapy2/59 (3.4%)0/59 (0%)0/59 (0%)
Exposure Therapy0/56 (0%)0/56 (0%)0/56 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)CRESTExposure TherapyTotal
Mean60.8 ± 9.162.8 ± 12.761.7 ± 11.0
Sex: Female, Male
Sex: Female, Male(Participants)CRESTExposure TherapyTotal
Female261642
Male334073
Race (NIH/OMB)
Race (NIH/OMB)(Participants)CRESTExposure TherapyTotal
American Indian or Alaska Native213
Asian156
Native Hawaiian or Other Pacific Islander336
Black or African American8614
White373572
More than one race358
Unknown or Not Reported516
Saving Inventory
Saving Inventory(units on a scale)CRESTExposure TherapyTotal
Mean59.9 ± 15.855.3 ± 14.857.7 ± 15.4
08

Study locations

1 site
  • VA San Diego Healthcare System, San Diego, CA
    San Diego, California 92161, United States
09

References and documents

Publications

  • Ayers CR, Zakrzewski JJ, Dozier ME, Mayes T, Thomas M, Twamley EW, Carty-Campbell A, Pittman J. Cognitive rehabilitation and exposure/sorting therapy for hoarding disorder: A randomized controlled trial. J Consult Clin Psychol. 2026 Aug;94(8):470-481. doi: 10.1037/ccp0001022. PubMed 42658588 ↗

Study documents

  • Protocol and statistical analysis plan · Feb 1, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02402647
Responsible party
Sponsor
First posted
Mar 30, 2015
Start date
Oct 1, 2015
Primary completion
Dec 31, 2021
Completion
Feb 1, 2023
Results posted
Sep 19, 2024
Last update
Sep 19, 2024

Study contacts

Catherine R Ayers, PhD
principal investigator · VA San Diego Healthcare System, San Diego, CA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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