Trial Outcomes & Findings for Cognitive Rehab and Exposure Treatment for Hoarding (NCT NCT02402647)

Last Updated: 2024-09-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

115 participants

Primary outcome timeframe

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

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Exposure Therapy 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. 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.
Overall Study STARTED	59	56
Overall Study COMPLETED	34	42
Overall Study NOT COMPLETED	25	14

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Exposure Therapy 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. 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.
Overall Study Lost to Follow-up	13	7
Overall Study Protocol Violation	1	1
Overall Study scheduled and timed out	2	1
Overall Study medical illness	2	4
Overall Study Moved	2	0
Overall Study loved one illness	1	0
Overall Study deceased preexisting condition	2	0
Overall Study Other	2	1

Baseline Characteristics

Cognitive Rehab and Exposure Treatment for Hoarding

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CREST n=59 Participants 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.	Exposure Therapy n=56 Participants 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. 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.	Total n=115 Participants Total of all reporting groups
Age, Continuous	60.8 years STANDARD_DEVIATION 9.1 • n=5 Participants	62.8 years STANDARD_DEVIATION 12.7 • n=7 Participants	61.7 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	16 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	40 Participants n=7 Participants	73 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	37 Participants n=5 Participants	35 Participants n=7 Participants	72 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Saving Inventory	59.9 units on a scale STANDARD_DEVIATION 15.8 • n=5 Participants	55.3 units on a scale STANDARD_DEVIATION 14.8 • n=7 Participants	57.7 units on a scale STANDARD_DEVIATION 15.4 • n=5 Participants

PRIMARY outcome

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

Population: For SI-R for individual missing responses replace with mean; individuals who missed more than 1/3 of the survey are excluded.

Outcome measures

Outcome measures
Measure	CREST n=59 Participants 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.	Exposure Therapy n=56 Participants 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. 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.
Saving Inventory Revised Baseline SI-R: Clutter Subcategory	25.2 score on a scale Standard Deviation 7.7	23.0 score on a scale Standard Deviation 8.2
Saving Inventory Revised Baseline SI-R: Acquisition Subcategory	16.6 score on a scale Standard Deviation 5.5	14.4 score on a scale Standard Deviation 5.4
Saving Inventory Revised Baseline SI-R: Discarding Subcategory	18.1 score on a scale Standard Deviation 5.5	17.9 score on a scale Standard Deviation 5.1
Saving Inventory Revised Timepoint 1 (S7) SI-R: Acquisition Subcategory	14.1 score on a scale Standard Deviation 5.8	12.9 score on a scale Standard Deviation 6.1
Saving Inventory Revised Timepoint 3 (S21) SI-R: Discarding Subcategory	13.5 score on a scale Standard Deviation 7.0	13.8 score on a scale Standard Deviation 5.7
Saving Inventory Revised 3 month post-treatment SI-R: Clutter Subcategory	16.2 score on a scale Standard Deviation 10.5	14.5 score on a scale Standard Deviation 8.9
Saving Inventory Revised 3 month post-treatment SI-R: Discarding Subcategory	11.3 score on a scale Standard Deviation 7.3	10.2 score on a scale Standard Deviation 6.4
Saving Inventory Revised 6 month post-treatment SI-R: Acquisition Subcategory	8.7 score on a scale Standard Deviation 5.2	6.7 score on a scale Standard Deviation 5.7
Saving Inventory Revised 6 month post-treatment SI-R: Discarding Subcategory	10.3 score on a scale Standard Deviation 6.7	9.9 score on a scale Standard Deviation 5.8
Saving Inventory Revised Timepoint 2 (S13) SI-R:	47.3 score on a scale Standard Deviation 17.7	45.5 score on a scale Standard Deviation 16.9
Saving Inventory Revised Baseline SI-R:	59.9 score on a scale Standard Deviation 15.8	55.3 score on a scale Standard Deviation 14.8
Saving Inventory Revised Timepoint 1 (S7) SI-R	51.6 score on a scale Standard Deviation 16.8	50.5 score on a scale Standard Deviation 16.4
Saving Inventory Revised Timepoint 1 (S7) SI-R: Clutter Subcategory	22.6 score on a scale Standard Deviation 8.4	21.7 score on a scale Standard Deviation 8.0
Saving Inventory Revised Timepoint 1 (S7) SI-R: Discarding Subcategory	14.9 score on a scale Standard Deviation 5.2	15.9 score on a scale Standard Deviation 5.0
Saving Inventory Revised Timepoint 2 (S13) SI-R: Clutter Subcategory	20.1 score on a scale Standard Deviation 8.7	19.6 score on a scale Standard Deviation 8.5
Saving Inventory Revised Timepoint 2 (S13) SI-R: Acquisition Subcategory	13.1 score on a scale Standard Deviation 6.3	11.5 score on a scale Standard Deviation 6.0
Saving Inventory Revised Timepoint 2 (S13) SI-R: Discarding Subcategory	14.2 score on a scale Standard Deviation 5.5	14.4 score on a scale Standard Deviation 5.1
Saving Inventory Revised Timepoint 3 (S21) SI-R:	45.0 score on a scale Standard Deviation 18.9	41.1 score on a scale Standard Deviation 17.3
Saving Inventory Revised Timepoint 3 (S21) SI-R: Clutter Subcategory	19.8 score on a scale Standard Deviation 8.3	18.1 score on a scale Standard Deviation 7.6
Saving Inventory Revised Timepoint 3 (S21) SI-R: Acquisition Subcategory	11.7 score on a scale Standard Deviation 6.2	9.3 score on a scale Standard Deviation 5.7
Saving Inventory Revised Post-Treatment SI-R:	37 score on a scale Standard Deviation 19.6	29.9 score on a scale Standard Deviation 18.6
Saving Inventory Revised Post-Treatment SI-R: Clutter Subcategory	16.1 score on a scale Standard Deviation 9.4	12.9 score on a scale Standard Deviation 8.8
Saving Inventory Revised Post-Treatment SI-R: Acquisition Subcategory	10.0 score on a scale Standard Deviation 6.1	7.3 score on a scale Standard Deviation 5.9
Saving Inventory Revised Post-Treatment SI-R: Discarding Subcategory	10.9 score on a scale Standard Deviation 6.4	9.8 score on a scale Standard Deviation 5.8
Saving Inventory Revised 3 month post-treatment SI-R:	37.5 score on a scale Standard Deviation 21.4	32.6 score on a scale Standard Deviation 20.4
Saving Inventory Revised 3 month post-treatment SI-R: Acquisition Subcategory	9.9 score on a scale Standard Deviation 6.5	7.9 score on a scale Standard Deviation 6.3
Saving Inventory Revised 6 month post-treatment SI-R:	34.3 score on a scale Standard Deviation 18.1	28.9 score on a scale Standard Deviation 18.9
Saving Inventory Revised 6 month post-treatment SI-R: Clutter Subcategory	15.2 score on a scale Standard Deviation 9.3	12.2 score on a scale Standard Deviation 9.0

SECONDARY outcome

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

Population: As the study progressed participants may have dropped out/left or refused to complete/answer and questions/tasks associated

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.

Outcome measures

Outcome measures
Measure	CREST n=59 Participants 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.	Exposure Therapy n=56 Participants 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. 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.
UCSD Performance-Based Skills Assessment (UPSA) Baseline UPSA	49.0 score on a scale Standard Deviation 7.4	49.1 score on a scale Standard Deviation 6.8
UCSD Performance-Based Skills Assessment (UPSA) Baseline UPSA: Financial Subcategory	18.3 score on a scale Standard Deviation 2.5	18.0 score on a scale Standard Deviation 2.2
UCSD Performance-Based Skills Assessment (UPSA) Baseline UPSA: Communication Subcategory	16.2 score on a scale Standard Deviation 2.6	15.3 score on a scale Standard Deviation 3.1
UCSD Performance-Based Skills Assessment (UPSA) Timepoint 1 (S7) UPSA: Financial Subcategory	18.8 score on a scale Standard Deviation 1.5	18.3 score on a scale Standard Deviation 2.3
UCSD Performance-Based Skills Assessment (UPSA) Timepoint 1 (S7) UPSA: Transportation Subcategory	15.9 score on a scale Standard Deviation 2.7	16.6 score on a scale Standard Deviation 2.9
UCSD Performance-Based Skills Assessment (UPSA) Timepoint 2 (S13) UPSA	52.7 score on a scale Standard Deviation 4.0	52.7 score on a scale Standard Deviation 5.2
UCSD Performance-Based Skills Assessment (UPSA) Timepoint 2 (S13) UPSA: Financial Subcategory	18.6 score on a scale Standard Deviation 1.7	1.1 score on a scale Standard Deviation 2.5
UCSD Performance-Based Skills Assessment (UPSA) Timepoint 2 (S13) UPSA: Communication Subcategory	16.7 score on a scale Standard Deviation 2.4	16.8 score on a scale Standard Deviation 2.4
UCSD Performance-Based Skills Assessment (UPSA) Timepoint 3 (S21) UPSA: Financial Subcategory	18.6 score on a scale Standard Deviation 1.7	18.1 score on a scale Standard Deviation 2.5
UCSD Performance-Based Skills Assessment (UPSA) Timepoint 3 (S21) UPSA: Communication Subcategory	16.7 score on a scale Standard Deviation 2.4	16.8 score on a scale Standard Deviation 2.4
UCSD Performance-Based Skills Assessment (UPSA) Timepoint 3 (S21) UPSA: Household Skills Subcategory	17.1 score on a scale Standard Deviation 4.0	17.6 score on a scale Standard Deviation 2.9
UCSD Performance-Based Skills Assessment (UPSA) Post Treatment UPSA: Communication Subcategory	16.3 score on a scale Standard Deviation 3.0	17.8 score on a scale Standard Deviation 1.7
UCSD Performance-Based Skills Assessment (UPSA) 6 month Follow Up UPSA: Transportation Subcategory	14.0 score on a scale Standard Deviation 6.5	18.0 score on a scale Standard Deviation 2.3
UCSD Performance-Based Skills Assessment (UPSA) Baseline UPSA: Comprehension/Planning Subcategory	14.5 score on a scale Standard Deviation 5.2	15.8 score on a scale Standard Deviation 4.2
UCSD Performance-Based Skills Assessment (UPSA) Baseline UPSA: Transportation Subcategory	16.2 score on a scale Standard Deviation 2.8	15.9 score on a scale Standard Deviation 3.8
UCSD Performance-Based Skills Assessment (UPSA) Baseline UPSA: Household Skills Subcategory	17.6 score on a scale Standard Deviation 3.7	18.5 score on a scale Standard Deviation 2.3
UCSD Performance-Based Skills Assessment (UPSA) Timepoint 1 (S7) UPSA	50.3 score on a scale Standard Deviation 8.3	50.9 score on a scale Standard Deviation 6.4
UCSD Performance-Based Skills Assessment (UPSA) Timepoint 1 (S7) UPSA: Communication Subcategory	15.9 score on a scale Standard Deviation 3.0	16.6 score on a scale Standard Deviation 2.0
UCSD Performance-Based Skills Assessment (UPSA) Timepoint 1 (S7) UPSA: Comprehension/Planning Subcategory	16.4 score on a scale Standard Deviation 3.5	16.0 score on a scale Standard Deviation 4.6
UCSD Performance-Based Skills Assessment (UPSA) Timepoint 1 (S7) UPSA: Household Skills Subcategory	18.3 score on a scale Standard Deviation 2.7	18.0 score on a scale Standard Deviation 2.8
UCSD Performance-Based Skills Assessment (UPSA) Timepoint 2 (S13) UPSA: Comprehension/Planning Subcategory	17.4 score on a scale Standard Deviation 3.2	17.8 score on a scale Standard Deviation 3.2
UCSD Performance-Based Skills Assessment (UPSA) Timepoint 2 (S13) UPSA: Transportation Subcategory	16.0 score on a scale Standard Deviation 2.5	16.8 score on a scale Standard Deviation 2.6
UCSD Performance-Based Skills Assessment (UPSA) Timepoint 2 (S13) UPSA: Household Skills Subcategory	17.1 score on a scale Standard Deviation 4.0	17.6 score on a scale Standard Deviation 2.9
UCSD Performance-Based Skills Assessment (UPSA) Timepoint 3 (S21) UPSA	52.7 score on a scale Standard Deviation 4.0	52.7 score on a scale Standard Deviation 5.2
UCSD Performance-Based Skills Assessment (UPSA) Timepoint 3 (S21) UPSA: Comprehension/Planning Subcategory	17.4 score on a scale Standard Deviation 3.2	17.8 score on a scale Standard Deviation 3.2
UCSD Performance-Based Skills Assessment (UPSA) Timepoint 3 (S21) UPSA: Transportation Subcategory	16.0 score on a scale Standard Deviation 2.5	16.8 score on a scale Standard Deviation 2.6
UCSD Performance-Based Skills Assessment (UPSA) Post Treatment UPSA	51.8 score on a scale Standard Deviation 7.2	54.6 score on a scale Standard Deviation 5.2
UCSD Performance-Based Skills Assessment (UPSA) Post Treatment UPSA: Financial Subcategory	18.3 score on a scale Standard Deviation 2.4	18.9 score on a scale Standard Deviation 1.7
UCSD Performance-Based Skills Assessment (UPSA) Post Treatment UPSA: Comprehension/Planning Subcategory	17.2 score on a scale Standard Deviation 4.6	17.9 score on a scale Standard Deviation 3.4
UCSD Performance-Based Skills Assessment (UPSA) Post Treatment UPSA: Transportation Subcategory	16.8 score on a scale Standard Deviation 2.1	17.0 score on a scale Standard Deviation 2.4
UCSD Performance-Based Skills Assessment (UPSA) Post Treatment UPSA: Household Skills Subcategory	17.3 score on a scale Standard Deviation 4.2	18.3 score on a scale Standard Deviation 2.4
UCSD Performance-Based Skills Assessment (UPSA) 3 month Follow Up UPSA	54.1 score on a scale Standard Deviation 4.5	54.0 score on a scale Standard Deviation 3.3
UCSD Performance-Based Skills Assessment (UPSA) 3 month Follow Up UPSA: Financial Subcategory	18.6 score on a scale Standard Deviation 2.1	18.8 score on a scale Standard Deviation 1.3
UCSD Performance-Based Skills Assessment (UPSA) 3 month Follow Up UPSA: Communication Subcategory	16.6 score on a scale Standard Deviation 2.7	17.2 score on a scale Standard Deviation 1.8
UCSD Performance-Based Skills Assessment (UPSA) 3 month Follow Up UPSA: Comprehension/Planning Subcategory	18.9 score on a scale Standard Deviation 1.9	18.7 score on a scale Standard Deviation 2.6
UCSD Performance-Based Skills Assessment (UPSA) 3 month Follow Up UPSA: Transportation Subcategory	15.2 score on a scale Standard Deviation 6.5	17.4 score on a scale Standard Deviation 2.7
UCSD Performance-Based Skills Assessment (UPSA) 3 month Follow Up UPSA: Household Skills Subcategory	15.6 score on a scale Standard Deviation 6.8	16.6 score on a scale Standard Deviation 5.3
UCSD Performance-Based Skills Assessment (UPSA) 6 month Follow Up UPSA:	52.5 score on a scale Standard Deviation 7.4	53.8 score on a scale Standard Deviation 5.0
UCSD Performance-Based Skills Assessment (UPSA) 6 month Follow Up UPSA: Financial Subcategory	19.1 score on a scale Standard Deviation 1.4	18.9 score on a scale Standard Deviation 1.4
UCSD Performance-Based Skills Assessment (UPSA) 6 month Follow Up UPSA: Communication Subcategory	15.8 score on a scale Standard Deviation 4.1	17.3 score on a scale Standard Deviation 2.7
UCSD Performance-Based Skills Assessment (UPSA) 6 month Follow Up UPSA: Comprehension/Planning Subcategory	17.5 score on a scale Standard Deviation 4.3	17.6 score on a scale Standard Deviation 3.0
UCSD Performance-Based Skills Assessment (UPSA) 6 month Follow Up UPSA: Household Skills Subcategory	20.0 score on a scale Standard Deviation 0.0	17.6 score on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: Baseline to 6 months post-treatment

Population: As the study progressed participants may have dropped out/left or refused to complete/answer and questions/tasks associated

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.

Outcome measures

Outcome measures
Measure	CREST n=59 Participants 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.	Exposure Therapy n=56 Participants 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. 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.
UCSD SORT Test Baseline USORT	33.1 score on a scale Standard Deviation 3.9	31.2 score on a scale Standard Deviation 4.7
UCSD SORT Test Timepoint 1 (S7) USORT	32.5 score on a scale Standard Deviation 5.0	32.7 score on a scale Standard Deviation 5.3
UCSD SORT Test Timepoint 3 (S21) USORT	33.2 score on a scale Standard Deviation 6.1	32.9 score on a scale Standard Deviation 4.4
UCSD SORT Test Post-Treatment USORT	34.5 score on a scale Standard Deviation 3.4	32.3 score on a scale Standard Deviation 5.2
UCSD SORT Test 3 month Post-Treatment USORT	36.1 score on a scale Standard Deviation 4.0	31.4 score on a scale Standard Deviation 6.9
UCSD SORT Test 6 month Post-Treatment USORT	35.9 score on a scale Standard Deviation 2.9	34.0 score on a scale Standard Deviation 5.2
UCSD SORT Test Timepoint 2 (S13) USORT	34.2 score on a scale Standard Deviation 4.1	34.2 score on a scale Standard Deviation 4.2

SECONDARY outcome

Timeframe: Baseline to 6 months post-treatment

Population: For SLOF regarding individual missing responses replaced with mean; individuals who missed more than 1/3 of the survey are excluded.

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.

Outcome measures

Outcome measures
Measure	CREST n=59 Participants 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.	Exposure Therapy n=56 Participants 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. 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.
Specific Levels of Functioning Test (SLOF) Baseline SLOF Overall	123.9 score on a scale Standard Deviation 12.9	128.0 score on a scale Standard Deviation 15.0
Specific Levels of Functioning Test (SLOF) Baseline Interpersonal Relationships Subscale	25.6 score on a scale Standard Deviation 6.2	24.7 score on a scale Standard Deviation 7.0
Specific Levels of Functioning Test (SLOF) Baseline Social Acceptability Subscale	26.6 score on a scale Standard Deviation 2.5	26.7 score on a scale Standard Deviation 2.5
Specific Levels of Functioning Test (SLOF) Baseline Work Skills Subscale	24.5 score on a scale Standard Deviation 4.9	25.2 score on a scale Standard Deviation 4.9
Specific Levels of Functioning Test (SLOF) Timepoint 1 (S7) SLOF Overall	127.0 score on a scale Standard Deviation 15.2	128.1 score on a scale Standard Deviation 13.9
Specific Levels of Functioning Test (SLOF) Timepoint 1 (S7) Interpersonal Relationships Subscale	23.1 score on a scale Standard Deviation 6.7	24.4 score on a scale Standard Deviation 7.0
Specific Levels of Functioning Test (SLOF) Timepoint 1 (S7) Activities Subscale	52.1 score on a scale Standard Deviation 4.4	52.2 score on a scale Standard Deviation 4.3
Specific Levels of Functioning Test (SLOF) Timepoint 2 (S13) Interpersonal Relationships Subscale	23.8 score on a scale Standard Deviation 6.4	23.4 score on a scale Standard Deviation 6.5
Specific Levels of Functioning Test (SLOF) Timepoint 3 (S21) Interpersonal Relationships Subscale	24.4 score on a scale Standard Deviation 6.7	23.7 score on a scale Standard Deviation 6.8
Specific Levels of Functioning Test (SLOF) Timepoint 3 (S21) Activities Subscale	51.7 score on a scale Standard Deviation 4.9	51.3 score on a scale Standard Deviation 5.2
Specific Levels of Functioning Test (SLOF) 3 month Follow Up SLOF Overall	133.9 score on a scale Standard Deviation 11.9	125.6 score on a scale Standard Deviation 16.8
Specific Levels of Functioning Test (SLOF) 3 month Follow Up Social Acceptability Subscale	28.0 score on a scale Standard Deviation 1.8	27.1 score on a scale Standard Deviation 2.4
Specific Levels of Functioning Test (SLOF) 3 month Follow Up Activities Subscale	53.7 score on a scale Standard Deviation 3.7	51.6 score on a scale Standard Deviation 5.3
Specific Levels of Functioning Test (SLOF) Baseline Activities Subscale	50.7 score on a scale Standard Deviation 4.8	51.8 score on a scale Standard Deviation 5.7
Specific Levels of Functioning Test (SLOF) Timepoint 1 (S7) Social Acceptability Subscale	26.8 score on a scale Standard Deviation 2.7	27.4 score on a scale Standard Deviation 2.0
Specific Levels of Functioning Test (SLOF) Timepoint 1 (S7) Work Skills Subscale	25.0 score on a scale Standard Deviation 4.9	24.2 score on a scale Standard Deviation 5.2
Specific Levels of Functioning Test (SLOF) Timepoint 2 (S13) SLOF Overall	128.5 score on a scale Standard Deviation 14.6	126.0 score on a scale Standard Deviation 15.0
Specific Levels of Functioning Test (SLOF) Timepoint 2 (S13) Social Acceptability Subscale	27.5 score on a scale Standard Deviation 2.3	27.0 score on a scale Standard Deviation 2.0
Specific Levels of Functioning Test (SLOF) Timepoint 2 (S13) Activities Subscale	52.3 score on a scale Standard Deviation 5.2	51.9 score on a scale Standard Deviation 5.3
Specific Levels of Functioning Test (SLOF) Timepoint 2 (S13) Work Skills Subscale	25.0 score on a scale Standard Deviation 4.7	23.6 score on a scale Standard Deviation 5.8
Specific Levels of Functioning Test (SLOF) Timepoint 3 (S21) SLOF Overall	128.3 score on a scale Standard Deviation 14.5	125.4 score on a scale Standard Deviation 14.8
Specific Levels of Functioning Test (SLOF) Timepoint 3 (S21) Social Acceptability Subscale	26.6 score on a scale Standard Deviation 4.6	27.2 score on a scale Standard Deviation 2.1
Specific Levels of Functioning Test (SLOF) Timepoint 3 (S21) Work Skills Subscale	25.6 score on a scale Standard Deviation 3.8	23.3 score on a scale Standard Deviation 5.3
Specific Levels of Functioning Test (SLOF) Post-Treatment SLOF Overall	131.9 score on a scale Standard Deviation 15.4	124.6 score on a scale Standard Deviation 15.9
Specific Levels of Functioning Test (SLOF) Post-Treatment Interpersonal Relationships Subscale	25.3 score on a scale Standard Deviation 7.1	23.2 score on a scale Standard Deviation 7.0
Specific Levels of Functioning Test (SLOF) Post-Treatment Social Acceptability Subscale	28.0 score on a scale Standard Deviation 2.0	27.2 score on a scale Standard Deviation 2.3
Specific Levels of Functioning Test (SLOF) Post-Treatment Activities Subscale	51.8 score on a scale Standard Deviation 8.3	51.3 score on a scale Standard Deviation 5.3
Specific Levels of Functioning Test (SLOF) Post-Treatment Work Skills Subscale	26.8 score on a scale Standard Deviation 3.7	22.9 score on a scale Standard Deviation 5.9
Specific Levels of Functioning Test (SLOF) 3 month Follow Up Interpersonal Relationships Subscale	25.6 score on a scale Standard Deviation 7.4	23.8 score on a scale Standard Deviation 6.9
Specific Levels of Functioning Test (SLOF) 3 month Follow Up Work Skills Subscale	26.6 score on a scale Standard Deviation 3.9	23.1 score on a scale Standard Deviation 6.3
Specific Levels of Functioning Test (SLOF) 6 month Follow Up SLOF Overall	133.2 score on a scale Standard Deviation 13.6	124.0 score on a scale Standard Deviation 20.0
Specific Levels of Functioning Test (SLOF) 6 month Follow Up Interpersonal Relationships Subscale	25.8 score on a scale Standard Deviation 7.0	24.6 score on a scale Standard Deviation 6.5
Specific Levels of Functioning Test (SLOF) 6 month Follow Up Social Acceptability Subscale	27.6 score on a scale Standard Deviation 2.2	27.7 score on a scale Standard Deviation 1.9
Specific Levels of Functioning Test (SLOF) 6 month Follow Up Activities Subscale	54.4 score on a scale Standard Deviation 1.8	50.9 score on a scale Standard Deviation 6.5
Specific Levels of Functioning Test (SLOF) 6 month Follow Up Work Skills Subscale	26.8 score on a scale Standard Deviation 4.0	23.5 score on a scale Standard Deviation 7.0

Adverse Events

Cognitive Rehabilitation and Exposure/Sorting Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Exposure Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Catherine Ayers

VA San Diego

Phone: 858-220-4041

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place