Hoarding Disorder
Conditions
Keywords
compulsive hoarding, clutter, hoarding disorder
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.
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.
Interventions
BEHAVIORALGroup 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.
BEHAVIORALPeer 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.
Sponsors
Patient-Centered Outcomes Research Institute
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Two-arm parallel clinical trial with assessments pre- and post-treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
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).
Participants by arm
| Arm | Count |
|---|---|
| Group Cognitive-Behavioral Therapy 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. | 160 |
| Peer Facilitated Support Group 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. | 163 |
| Total | 323 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 14 | 9 |
| Overall Study | Withdrawal by Subject | 28 | 41 |
Baseline characteristics
| Characteristic | Group Cognitive-Behavioral Therapy | Peer Facilitated Support Group | Total |
|---|---|---|---|
| Age, Continuous | 59.0 years STANDARD_DEVIATION 10.9 | 58.9 years STANDARD_DEVIATION 10.6 | 59.0 years STANDARD_DEVIATION 10.7 |
| Race/Ethnicity, Customized Race/Ethnicity Characteristics American Indian/Alaskan Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Characteristics Asian | 16 Participants | 17 Participants | 33 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Characteristics Black/African American | 17 Participants | 6 Participants | 23 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Characteristics Hispanic | 9 Participants | 8 Participants | 17 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Characteristics Native Hawaiian/Other Pacific Islander | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Characteristics Other or Multiracial | 23 Participants | 23 Participants | 46 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Characteristics Prefer not to answer | 4 Participants | 5 Participants | 9 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Characteristics White | 89 Participants | 101 Participants | 190 Participants |
| Sex: Female, Male Female | 117 Participants | 124 Participants | 241 Participants |
| Sex: Female, Male Male | 43 Participants | 39 Participants | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 160 | 0 / 163 |
| other Total, other adverse events | 1 / 160 | 2 / 163 |
| serious Total, serious adverse events | 0 / 160 | 0 / 163 |
Outcome results
Primary
Saving Inventory-Revised (SI-R)
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).
Population: All randomized participants who were not lost to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Cognitive-Behavioral Therapy | Saving Inventory-Revised (SI-R) | Baseline | 64.5 units on a scale | Standard Deviation 11.7 |
| Group Cognitive-Behavioral Therapy | Saving Inventory-Revised (SI-R) | End of Treatment: 20 weeks later | 45.9 units on a scale | Standard Deviation 15 |
| Peer Facilitated Support Group | Saving Inventory-Revised (SI-R) | Baseline | 66.4 units on a scale | Standard Deviation 11.6 |
| Peer Facilitated Support Group | Saving Inventory-Revised (SI-R) | End of Treatment: 20 weeks later | 47.8 units on a scale | Standard Deviation 14.2 |
Comparison: Test of non-inferiority.p-value: 0.04t-test, 1 sided
Secondary
Activities of Daily Living Scale, Hoarding (ADL-H)
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).
Population: All randomized participants who were not lost to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Cognitive-Behavioral Therapy | Activities of Daily Living Scale, Hoarding (ADL-H) | Baseline | 29.9 units on a scale | Standard Deviation 9.5 |
| Group Cognitive-Behavioral Therapy | Activities of Daily Living Scale, Hoarding (ADL-H) | End of Treatment: 20 weeks later | 25.5 units on a scale | Standard Deviation 10.1 |
| Peer Facilitated Support Group | Activities of Daily Living Scale, Hoarding (ADL-H) | Baseline | 32.0 units on a scale | Standard Deviation 11.2 |
| Peer Facilitated Support Group | Activities of Daily Living Scale, Hoarding (ADL-H) | End of Treatment: 20 weeks later | 26.1 units on a scale | Standard Deviation 8.7 |
Comparison: Test of non-inferiority.p-value: 0.05t-test, 1 sided
Post Hoc
Longitudinal Follow-Up: Activities of Daily Living Scale, Hoarding (ADL-H)
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.
Population: All randomized participants who were not lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Cognitive-Behavioral Therapy | Longitudinal Follow-Up: Activities of Daily Living Scale, Hoarding (ADL-H) | 27.6 units on a scale | Standard Deviation 11.6 |
| Peer Facilitated Support Group | Longitudinal Follow-Up: Activities of Daily Living Scale, Hoarding (ADL-H) | 27.8 units on a scale | Standard Deviation 9.7 |
p-value: <0.0001Mixed Models Analysis
Post Hoc
Longitudinal Follow-Up: Saving Inventory-Revised (SI-R)
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.
Population: All randomized participants who were not lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Cognitive-Behavioral Therapy | Longitudinal Follow-Up: Saving Inventory-Revised (SI-R) | 48.2 units on a scale | Standard Deviation 14.9 |
| Peer Facilitated Support Group | Longitudinal Follow-Up: Saving Inventory-Revised (SI-R) | 47.9 units on a scale | Standard Deviation 13.9 |
p-value: <0.0001Mixed Models Analysis