Comparison of Treatment for Hoarding Disorder

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT02040805
• Collaborator: Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 323
• Locations: 2
• Arms: 2
• Actual Duration (Months): 35
• Patients Per Site: 161.5
• Patients Per Site Per Month: 4.6

Study Details

Study Description

Brief Summary

This study proposes to compare two forms of treatment for Hoarding Disorder (HD), a common and impairing neuropsychiatric syndrome that has a profound impact on the lives and functioning of individuals, families, and society. Specifically, we will compare a novel community-based group treatment led by individuals from the community who are not mental health professionals to the current standard of care treatment for Hoarding Disorder, Cognitive Behavioral Therapy, conducted by psychologists in a group setting. We hypothesized that both treatment types will be similarly effective in reducing hoarding severity.

Condition or Disease	Intervention/Treatment	Phase
Hoarding Disorder	Behavioral: Group Cognitive Behavioral Therapy; Behavioral: Peer Facilitated Support Group	N/A

Detailed Description

The study design for this proposal is a stratified, randomized, single-blind, non- inferiority trial comparing the current standard of care for treatment of Hoarding Disorder (HD), Group Cognitive Behavioral Therapy (G-CBT), to an innovative and promising community-based treatment, Group Buried in Treasures (G-BiT). Participants will be stratified by gender, psychiatric status (high vs. low burden of psychiatric symptoms) and insurance status (insured vs. under- or un-insured) so that equal numbers of individuals with each of these characteristics are randomized to each treatment arm. They will then be randomly assigned (randomized) to either G-CBT or G-BiT. Participants will know which treatment group they are assigned to, but those members of the research team who are conducting clinical or neuropsychological assessments or analyzing the data will not; they will be blinded to participant group assignment, and group leaders will be blinded to the psychiatric status, neurocognitive status, insurance status, etc, of participants. The study is a non-inferiority trial, that is, the hypothesis to be tested is that G-BiT is as effective, or no less effective, than G-CBT. We chose a non-inferiority design because we have no reason to believe G-BiT is better than G-CBT and our preliminary data, as well as outcomes previously reported for G- CBT and G-BiT, suggest that these treatments may have similar efficacies.

Study Design

• Study Type: Interventional
• Actual Enrollment: 323 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Two-arm parallel clinical trial with assessments pre- and post-treatment.Two-arm parallel clinical trial with assessments pre- and post-treatment.
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of Peer Facilitated Support Group and Cognitive Behavioral Therapy for Hoarding Disorder
• Actual Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Dec 31, 2016
• Actual Study Completion Date: Dec 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group Cognitive-Behavioral Therapy Sixteen sessions of group therapy facilitated by a psychologist.	Behavioral: Group Cognitive Behavioral Therapy; Group therapy over approximately 20 weeks, based on a structured manual adapted from the individual CBT workbook for hoarding by Steketee and Frost (2006). Each session will be 2 hours in length and consists of weekly check-ins, psychoeducation about hoarding, developing understanding and awareness of one's hoarding symptoms and patterns, behavior modification, cognitive restructuring, goal-setting, motivational enhancement, in vivo and imaginal exposure for discarding and acquisition, executive skills training (organization, sorting, planning, decision-making, problem-solving, etc.), guidelines on establishing "clutter buddies", and relapse prevention. Groups will be led by clinical postdoctoral psychology fellows in the Department of Psychiatry at UCSF.
Experimental: Peer Facilitated Support Group Fifteen sessions of peer-facilitated group support.	Behavioral: Peer Facilitated Support Group; Fifteen sessions of peer facilitated, group support, over the course of 20 weeks, based on a structured manualized approach (Buried in Treasures: Help for Compulsive Acquiring, Saving, and Hoarding). Each session will be 2 hours in length. In this model, two trained peers, usually, but not necessarily, with personal lived experience of hoarding, will guide the group chapter by chapter through the Buried in Treasures manual.

Outcome Measures

Primary Outcome Measures

1. Saving Inventory-Revised (SI-R) [Administered at screening before start of treatment groups and after last treatment group (20 weeks later).]

   This is a 23-item self-report questionnaire that measures hoarding symptoms and their impact, including problems with acquisition, clutter, and difficulty discarding, as well as distress and impairment/interference. The SI-R is scored on a scale of 0-92. Higher scores indicate more severe hoarding, and scores of 42 and over are considered clinically significant hoarding. Although subscale scores can be calculated, this study uses total scores as the primary outcome.

Secondary Outcome Measures

1. Activities of Daily Living Scale, Hoarding (ADL-H) [Administered at baseline and after last treatment group (20 weeks later).]

   The ADL-H is a 15-item self-report questionnaire that measures hoarding specific difficulties or problems that may impact daily functioning. It includes questions on activities affected by clutter or hoarding, problems in the home, and safety issues. For this study, the score on each ADL-H item was summed to create a total score ranging from 0 to 75. Higher scores indicate more severe functional impairment due to hoarding.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of Hoarding Disorder

Exclusion Criteria:

• Individuals with active psychosis, schizophrenia, intellectual disability, or known dementia will be excluded

• Individuals who have participated in either cognitive-behavioral therapy for hoarding (group or individual) or in group Buried in Treasures in the past year

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mental Health Association	San Francisco	California	United States	94102
2	University of California, San Francisco	San Francisco	California	United States	94143

Sponsors and Collaborators

• University of California, San Francisco
• Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Carol A. Mathews, MD, University of Florida
• Principal Investigator: Kevin L. Delucchi, PhD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT02040805
• Other Study ID Numbers: CE-1304-6000
• First Posted: Jan 20, 2014
• Last Update Posted: Feb 11, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of California, San Francisco: compulsive hoarding; clutter; hoarding disorder
• Additional relevant MeSH terms: Disease; Hoarding Disorder

Study Results

Participant Flow

Recruitment Details	Recruitment occurred during April 2014 through February 2016. Participants were individuals with Hoarding Disorder recruited primarily through the Mental Health Association - San Francisco and flyers in the bay area (e.g. community center boards, coffee shops, laundry mats, libraries).

Arm/Group Title	Group Cognitive-Behavioral Therapy	Peer Facilitated Support Group
Arm/Group Description	Sixteen sessions of group therapy facilitated by a psychologist. Group Cognitive Behavioral Therapy: Group therapy over approximately 20 weeks, based on a structured manual adapted from the individual CBT workbook for hoarding by Steketee and Frost (2006). Each session will be 2 hours in length and consists of weekly check-ins, psychoeducation about hoarding, developing understanding and awareness of one's hoarding symptoms and patterns, behavior modification, cognitive restructuring, goal-setting, motivational enhancement, in vivo and imaginal exposure for discarding and acquisition, executive skills training (organization, sorting, planning, decision-making, problem-solving, etc.), guidelines on establishing "clutter buddies", and relapse prevention. Groups will be led by clinical postdoctoral psychology fellows in the Department of Psychiatry at UCSF.	Fifteen sessions of peer-facilitated group support. Peer Facilitated Support Group: Fifteen sessions of peer facilitated, group support, over the course of 20 weeks, based on a structured manualized approach (Buried in Treasures: Help for Compulsive Acquiring, Saving, and Hoarding). Each session will be 2 hours in length. In this model, two trained peers, usually, but not necessarily, with personal lived experience of hoarding, will guide the group chapter by chapter through the Buried in Treasures manual.
Period Title: Overall Study
STARTED	160	163
COMPLETED	118	113
NOT COMPLETED	42	50

Baseline Characteristics

Arm/Group Title	Group Cognitive-Behavioral Therapy	Peer Facilitated Support Group	Total
Arm/Group Description	Sixteen sessions of group therapy facilitated by a psychologist. Group Cognitive Behavioral Therapy: Group therapy over approximately 20 weeks, based on a structured manual adapted from the individual CBT workbook for hoarding by Steketee and Frost (2006). Each session will be 2 hours in length and consists of weekly check-ins, psychoeducation about hoarding, developing understanding and awareness of one's hoarding symptoms and patterns, behavior modification, cognitive restructuring, goal-setting, motivational enhancement, in vivo and imaginal exposure for discarding and acquisition, executive skills training (organization, sorting, planning, decision-making, problem-solving, etc.), guidelines on establishing "clutter buddies", and relapse prevention. Groups will be led by clinical postdoctoral psychology fellows in the Department of Psychiatry at UCSF.	Fifteen sessions of peer-facilitated group support. Peer Facilitated Support Group: Fifteen sessions of peer facilitated, group support, over the course of 20 weeks, based on a structured manualized approach (Buried in Treasures: Help for Compulsive Acquiring, Saving, and Hoarding). Each session will be 2 hours in length. In this model, two trained peers, usually, but not necessarily, with personal lived experience of hoarding, will guide the group chapter by chapter through the Buried in Treasures manual.	Total of all reporting groups
Overall Participants	160	163	323
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.0 (10.9)	58.9 (10.6)	59.0 (10.7)
Sex: Female, Male (Count of Participants)
Female	117 73.1%	124 76.1%	241 74.6%
Male	43 26.9%	39 23.9%	82 25.4%
Race/Ethnicity, Customized (Count of Participants)
American Indian/Alaskan Native	0 0%	1 0.6%	1 0.3%
Asian	16 10%	17 10.4%	33 10.2%
Black/African American	17 10.6%	6 3.7%	23 7.1%
Hispanic	9 5.6%	8 4.9%	17 5.3%
Native Hawaiian/Other Pacific Islander	2 1.3%	1 0.6%	3 0.9%
Other or Multiracial	23 14.4%	23 14.1%	46 14.2%
White	89 55.6%	101 62%	190 58.8%
Prefer not to answer	4 2.5%	5 3.1%	9 2.8%

Outcome Measures

1. Primary Outcome

Title	Saving Inventory-Revised (SI-R)
Description	This is a 23-item self-report questionnaire that measures hoarding symptoms and their impact, including problems with acquisition, clutter, and difficulty discarding, as well as distress and impairment/interference. The SI-R is scored on a scale of 0-92. Higher scores indicate more severe hoarding, and scores of 42 and over are considered clinically significant hoarding. Although subscale scores can be calculated, this study uses total scores as the primary outcome.
Time Frame	Administered at screening before start of treatment groups and after last treatment group (20 weeks later).

Outcome Measure Data

Analysis Population Description

All randomized participants who were not lost to follow-up.

Arm/Group Title	Group Cognitive-Behavioral Therapy	Peer Facilitated Support Group
Arm/Group Description	Sixteen sessions of group therapy facilitated by a psychologist. Group Cognitive Behavioral Therapy: Group therapy over approximately 20 weeks, based on a structured manual adapted from the individual CBT workbook for hoarding by Steketee and Frost (2006). Each session will be 2 hours in length and consists of weekly check-ins, psychoeducation about hoarding, developing understanding and awareness of one's hoarding symptoms and patterns, behavior modification, cognitive restructuring, goal-setting, motivational enhancement, in vivo and imaginal exposure for discarding and acquisition, executive skills training (organization, sorting, planning, decision-making, problem-solving, etc.), guidelines on establishing "clutter buddies", and relapse prevention. Groups will be led by clinical postdoctoral psychology fellows in the Department of Psychiatry at UCSF.	Fifteen sessions of peer-facilitated group support. Peer Facilitated Support Group: Fifteen sessions of peer facilitated, group support, over the course of 20 weeks, based on a structured manualized approach (Buried in Treasures: Help for Compulsive Acquiring, Saving, and Hoarding). Each session will be 2 hours in length. In this model, two trained peers, usually, but not necessarily, with personal lived experience of hoarding, will guide the group chapter by chapter through the Buried in Treasures manual.
Measure Participants	160	163
Baseline	64.5 (11.7)	66.4 (11.6)
End of Treatment: 20 weeks later	45.9 (15.0)	47.8 (14.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group Cognitive-Behavioral Therapy, Peer Facilitated Support Group
	Comments	Test of non-inferiority.
	Type of Statistical Test	Non-Inferiority
	Comments	Margin based on clinically meaningful change of >= 5 points.
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	t-test, 1 sided
	Comments

2. Secondary Outcome

Title	Activities of Daily Living Scale, Hoarding (ADL-H)
Description	The ADL-H is a 15-item self-report questionnaire that measures hoarding specific difficulties or problems that may impact daily functioning. It includes questions on activities affected by clutter or hoarding, problems in the home, and safety issues. For this study, the score on each ADL-H item was summed to create a total score ranging from 0 to 75. Higher scores indicate more severe functional impairment due to hoarding.
Time Frame	Administered at baseline and after last treatment group (20 weeks later).

Outcome Measure Data

Analysis Population Description

All randomized participants who were not lost to follow-up.

Arm/Group Title	Group Cognitive-Behavioral Therapy	Peer Facilitated Support Group
Arm/Group Description	Sixteen sessions of group therapy facilitated by a psychologist. Group Cognitive Behavioral Therapy: Group therapy over approximately 20 weeks, based on a structured manual adapted from the individual CBT workbook for hoarding by Steketee and Frost (2006). Each session will be 2 hours in length and consists of weekly check-ins, psychoeducation about hoarding, developing understanding and awareness of one's hoarding symptoms and patterns, behavior modification, cognitive restructuring, goal-setting, motivational enhancement, in vivo and imaginal exposure for discarding and acquisition, executive skills training (organization, sorting, planning, decision-making, problem-solving, etc.), guidelines on establishing "clutter buddies", and relapse prevention. Groups will be led by clinical postdoctoral psychology fellows in the Department of Psychiatry at UCSF.	Fifteen sessions of peer-facilitated group support. Peer Facilitated Support Group: Fifteen sessions of peer facilitated, group support, over the course of 20 weeks, based on a structured manualized approach (Buried in Treasures: Help for Compulsive Acquiring, Saving, and Hoarding). Each session will be 2 hours in length. In this model, two trained peers, usually, but not necessarily, with personal lived experience of hoarding, will guide the group chapter by chapter through the Buried in Treasures manual.
Measure Participants	160	163
Baseline	29.9 (9.5)	32.0 (11.2)
End of Treatment: 20 weeks later	25.5 (10.1)	26.1 (8.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group Cognitive-Behavioral Therapy, Peer Facilitated Support Group
	Comments	Test of non-inferiority.
	Type of Statistical Test	Non-Inferiority
	Comments	Margin based on clinically meaningful change of >= 2.5 points.
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	t-test, 1 sided
	Comments

3. Post-Hoc Outcome

Title	Longitudinal Follow-Up: Saving Inventory-Revised (SI-R)
Description	This is a 23-item self-report questionnaire that measures hoarding symptoms and their impact, including problems with acquisition, clutter, and difficulty discarding, as well as distress and impairment/interference. Using the SI-R, we obtained longitudinal follow-up data (defined as a second post-treatment assessment of hoarding symptom severity at least three months following completion of treatment). The total SI-R score was used, which ranges from 0-92, higher scores indicating more severe hoarding.
Time Frame	The post-hoc longitudinal data were collected at varying time points, but at least three months after the treatment ended. The range was 3 months to 25 months, with a mean of 14 months after treatment end.

Outcome Measure Data

Analysis Population Description

All randomized participants who were not lost to follow-up.

Arm/Group Title	Group Cognitive-Behavioral Therapy	Peer Facilitated Support Group
Arm/Group Description	Sixteen sessions of group therapy facilitated by a psychologist. Group Cognitive Behavioral Therapy: Group therapy over approximately 20 weeks, based on a structured manual adapted from the individual CBT workbook for hoarding by Steketee and Frost (2006). Each session will be 2 hours in length and consists of weekly check-ins, psychoeducation about hoarding, developing understanding and awareness of one's hoarding symptoms and patterns, behavior modification, cognitive restructuring, goal-setting, motivational enhancement, in vivo and imaginal exposure for discarding and acquisition, executive skills training (organization, sorting, planning, decision-making, problem-solving, etc.), guidelines on establishing "clutter buddies", and relapse prevention. Groups will be led by clinical postdoctoral psychology fellows in the Department of Psychiatry at UCSF.	Fifteen sessions of peer-facilitated group support. Peer Facilitated Support Group: Fifteen sessions of peer facilitated, group support, over the course of 20 weeks, based on a structured manualized approach (Buried in Treasures: Help for Compulsive Acquiring, Saving, and Hoarding). Each session will be 2 hours in length. In this model, two trained peers, usually, but not necessarily, with personal lived experience of hoarding, will guide the group chapter by chapter through the Buried in Treasures manual.
Measure Participants	101	82
Mean (Standard Deviation) [units on a scale]	48.2 (14.9)	47.9 (13.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group Cognitive-Behavioral Therapy, Peer Facilitated Support Group
	Comments
	Type of Statistical Test	Other
	Comments	linear mixed models analysis
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments	df=1

4. Post-Hoc Outcome

Title	Longitudinal Follow-Up: Activities of Daily Living Scale, Hoarding (ADL-H)
Description	The ADL-H is a 15-item self-report questionnaire that measures hoarding specific difficulties or problems that may impact daily functioning. It includes questions on activities affected by clutter or hoarding, problems in the home, and safety issues. Using the ADL-H, we obtained longitudinal follow-up data (defined as a second post-treatment assessment of hoarding specific difficulties or problems that may impact daily functioning at least three months following completion of treatment). For this study, a total score using the sum of all of the items was created, ranging from 0 to a total possible of 75. Higher scores indicate more severe impairment due to hoarding.
Time Frame	Post-hoc longitudinal analyses were conducted at three or more months' following the end of treatment. The range was 3-25 months, and the mean time to longitudinal follow up was 14 months.

Outcome Measure Data

Analysis Population Description

All randomized participants who were not lost to follow-up.

Arm/Group Title	Group Cognitive-Behavioral Therapy	Peer Facilitated Support Group
Arm/Group Description	Sixteen sessions of group therapy facilitated by a psychologist. Group Cognitive Behavioral Therapy: Group therapy over approximately 20 weeks, based on a structured manual adapted from the individual CBT workbook for hoarding by Steketee and Frost (2006). Each session will be 2 hours in length and consists of weekly check-ins, psychoeducation about hoarding, developing understanding and awareness of one's hoarding symptoms and patterns, behavior modification, cognitive restructuring, goal-setting, motivational enhancement, in vivo and imaginal exposure for discarding and acquisition, executive skills training (organization, sorting, planning, decision-making, problem-solving, etc.), guidelines on establishing "clutter buddies", and relapse prevention. Groups will be led by clinical postdoctoral psychology fellows in the Department of Psychiatry at UCSF.	Fifteen sessions of peer-facilitated group support. Peer Facilitated Support Group: Fifteen sessions of peer facilitated, group support, over the course of 20 weeks, based on a structured manualized approach (Buried in Treasures: Help for Compulsive Acquiring, Saving, and Hoarding). Each session will be 2 hours in length. In this model, two trained peers, usually, but not necessarily, with personal lived experience of hoarding, will guide the group chapter by chapter through the Buried in Treasures manual.
Measure Participants	98	80
Mean (Standard Deviation) [units on a scale]	27.6 (11.6)	27.8 (9.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group Cognitive-Behavioral Therapy, Peer Facilitated Support Group
	Comments
	Type of Statistical Test	Other
	Comments	linear mixed model
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments	df=1

Adverse Events

Arm/Group Title	Group Cognitive-Behavioral Therapy		Peer Facilitated Support Group
Arm/Group Description	Sixteen sessions of group therapy facilitated by a psychologist. Group Cognitive Behavioral Therapy: Group therapy over approximately 20 weeks, based on a structured manual adapted from the individual CBT workbook for hoarding by Steketee and Frost (2006). Each session will be 2 hours in length and consists of weekly check-ins, psychoeducation about hoarding, developing understanding and awareness of one's hoarding symptoms and patterns, behavior modification, cognitive restructuring, goal-setting, motivational enhancement, in vivo and imaginal exposure for discarding and acquisition, executive skills training (organization, sorting, planning, decision-making, problem-solving, etc.), guidelines on establishing "clutter buddies", and relapse prevention. Groups will be led by clinical postdoctoral psychology fellows in the Department of Psychiatry at UCSF.		Fifteen sessions of peer-facilitated group support. Peer Facilitated Support Group: Fifteen sessions of peer facilitated, group support, over the course of 20 weeks, based on a structured manualized approach (Buried in Treasures: Help for Compulsive Acquiring, Saving, and Hoarding). Each session will be 2 hours in length. In this model, two trained peers, usually, but not necessarily, with personal lived experience of hoarding, will guide the group chapter by chapter through the Buried in Treasures manual.
All Cause Mortality
	Group Cognitive-Behavioral Therapy		Peer Facilitated Support Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/160 (0%)		0/163 (0%)
Serious Adverse Events
	Group Cognitive-Behavioral Therapy		Peer Facilitated Support Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/160 (0%)		0/163 (0%)
Other (Not Including Serious) Adverse Events
	Group Cognitive-Behavioral Therapy		Peer Facilitated Support Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/160 (0.6%)		2/163 (1.2%)
Psychiatric disorders
Voluntary hospitalization due to "alcohol detox" "possible suicidality"	1/160 (0.6%)		0/163 (0%)
Suicidality	0/160 (0%)		1/163 (0.6%)
Social circumstances
Participant Fell	0/160 (0%)		1/163 (0.6%)

Limitations/Caveats

The primary limitation in this study was loss to follow up. Additionally, the longitudinal follow-up assessment was post-hoc rather than being planned prior to study initiation.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.