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Web-based Acceptance and Commitment Therapy for Hoarding Disorder

Primary Purpose

Hoarding Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACT Website and Coaching
Sponsored by
Utah State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hoarding Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 years old or older
  2. Living in the USA
  3. Seeking help for clutter and/or hoarding
  4. Interested in testing a self-help website
  5. Scoring at or above the clinical cutoff of 41 on the Saving Inventory-Revised

Exclusion Criteria:

  1. 17 years or younger
  2. Living outside the USA
  3. Not seeking help for clutter and/or hoarding
  4. Not interested in testing a self-help website
  5. Scoring below 41 on the Saving Inventory-Revised

Sites / Locations

  • Utah State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ACT Website and Coaching Condition

Waitlist Condition

Arm Description

Participants will be asked to complete 16 brief self-help website sessions, each taking around 15-20 minutes to finish, twice a week for eight weeks. Website exercises and examples primarily focus on hoarding, although some examples also discuss related mental health concerns such as anxiety, low mood, health behaviors, etc. The sessions use multimedia and are interactive. Participants assigned to the website condition will also receive coaching. The purpose of coaching will be to help participants engage with the website and adhere to the intervention. Coaching will consist of an initial phone call of 10-15 minutes followed by weekly email contact during the 8-week treatment period. Coaches will be graduate students trained in clinical psychology.

Participants assigned to the waitlist will be asked to wait 12 weeks without intervention (access to the website or coaching). They will receive access to the website after 12 weeks, but supportive coaching will not be provided to waitlist participants.

Outcomes

Primary Outcome Measures

Saving Inventory-Revised (SI-R; Frost et al., 2004)
A self-report measure of hoarding symptoms

Secondary Outcome Measures

Sheehan Disability Scale (Sheehan, Harnett-Sheehan, & Raj, 1996)
A self-report measure of functional impairment due to symptoms. Higher scores indicate greater impairment. Scores range from 0 to 30.
Clinical Global Impression - Improvement (CGI-I; Guy, 1976).
A self-report measure of overall improvement in symptoms
General Health Questionnaire-12 (GHQ-12; Goldberg, 1978)
A self-report measure of overall psychological distress
Stigma of hoarding items (Chasson et al., 2018)
Seven self-report items assessing stigma towards individuals with hoarding disorder. These items are not a standardized scale but have been used in previous research (Chasson et al., 2018). Three items assess perceived difference (Example: How like or unlike do you think is a person with obsessive-compulsive disorder compared to everyone else in the general population?), three items assess disdain (Example: How good or bad do you think is a person with hoarding disorder compared to everyone else in the general population?) and one item assesses blame: How responsible do you think a person with serious mental illness is for his or her condition?
Acceptance and Action Questionnaire for Hoarding (AAQH; Krafft et al., in press)
A self-report measure of hoarding-related psychological inflexibility
Five-Facet Mindfulness Questionnaire - Acting with Awareness (FFMQ-AA; Baer, Smith, Hopkins, Krietemeyer, & Toney, 2006)
A self-report measure of the acting with awareness facet of mindfulness
Valuing Questionnaire-Progress (VQ-Progress; Smout, Davies, Burns, & Christie, 2014)
A self-report measure of progress toward personal values
Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000).
A self-report measure of the perceived credibility of and expectations toward a treatment. Only administered to treatment condition
System Usability Scale (Tullis & Albert, 2008)
A self-report measure of usability of a technological system. Only administered to treatment condition. High scores indicated greater usability, and scores range from 0 to 100.
Treatment Evaluation Inventory-Short Form (TEI-SF; Kelley, Heffer, Gresham, & Elliott, 1989).
A self-report measure of treatment acceptability. Only administered to treatment condition
Novel satisfaction item 1
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "Overall, I was satisfied with the quality of the program." This is a novel satisfaction item specific to this study. Only administered to treatment condition
Novel satisfaction item 2
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "The program was helpful to me." This is a novel satisfaction item specific to this study. Only administered to treatment condition
Novel satisfaction item 3
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "The program was easy to use." This is a novel satisfaction item specific to this study. Only administered to treatment condition
Novel satisfaction item 4
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "I felt the program was made for someone like me." This is a novel satisfaction item specific to this study. Only administered to treatment condition
Novel satisfaction item 5
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "I would recommend the program to other people with a clutter and/or hoarding problem." This is a novel satisfaction item specific to this study. Only administered to treatment condition
Novel satisfaction item 6
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "The psychological skills taught (ex. mindfulness, opening up) were helpful to me." This is a novel satisfaction item specific to this study. Only administered to treatment condition
Novel satisfaction item 7
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "The practice exercises (ex. discarding, goal setting) were helpful to me." This is a novel satisfaction item specific to this study. Only administered to treatment condition
Novel satisfaction item 8
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "This treatment fit well with my goals." This is a novel satisfaction item specific to this study. Only administered to treatment condition
Novel satisfaction item 9
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "Overall, I was satisfied with the coaching that I received." This is a novel satisfaction item specific to this study. Only administered to treatment condition
Novel satisfaction item 10
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "The website would have been just as useful without a coach." This is a novel satisfaction item specific to this study. Only administered to treatment condition
Novel satisfaction item 11
Participants will be asked an open-ended question to gather qualitative feedback on the intervention. Only assigned to treatment condition. The question is, "What did you like best about the Making Space program?"
Novel satisfaction item 12
Participants will be asked an open-ended question to gather qualitative feedback on the intervention. Only assigned to treatment condition. The question is, "What was the most important thing you learned from the Making Space program?"
Novel satisfaction item 13
Participants will be asked an open-ended question to gather qualitative feedback on the intervention. Only assigned to treatment condition. The question is, "What did you like least about the Making Space Program? Why did you like this the least?"
Novel satisfaction item 14
Participants will be asked an open-ended question to gather qualitative feedback on the intervention. Only assigned to treatment condition. The question is, "Do you have any other comments or suggestions regarding our Making Space program?"

Full Information

First Posted
January 13, 2020
Last Updated
April 26, 2021
Sponsor
Utah State University
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1. Study Identification

Unique Protocol Identification Number
NCT04239729
Brief Title
Web-based Acceptance and Commitment Therapy for Hoarding Disorder
Official Title
A Randomized Waitlist-controlled Trial of Web-based Acceptance and Commitment Therapy for Hoarding Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 17, 2020 (Actual)
Primary Completion Date
November 27, 2020 (Actual)
Study Completion Date
November 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Utah State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will help to determine if acceptance and commitment therapy delivered as a web-based intervention is a useful treatment for hoarding disorder and evaluate whether or not web-based treatment for hoarding is credible and acceptable. It may also help identify novel processes of change in hoarding treatment such as psychological inflexibility, mindfulness, and self-stigma.
Detailed Description
The efficacy of an ACT self-help website for hoarding will be assessed through a randomized, waitlist-controlled trial. Participants will be recruited from within the United States through a variety of channels. Given the need to recruit a targeted sample with clinical levels of hoarding symptoms, online advertisements through Facebook and Google AdWords will be the primary recruitment method. Participants will complete an initial brief screening, provide consent, and then complete a baseline survey. Each of these steps will be completed online and participants will be automatically guided from each step to the next. That is, those who screen as eligible will be automatically directed to an online consent form, and those who provide consent will be automatically directed to begin the initial online baseline survey. They will be randomly assigned automatically upon completing the baseline survey to either use the ACT self-help website and receive supportive coaching for the next 8 weeks, or wait for the next 8 weeks. After 8 weeks, participants will be asked to complete a posttreatment survey. They will be asked to complete a final, follow-up survey after an additional 4 weeks after the posttreatment survey. After the follow-up survey is completed, waitlisted participants will be provided with access to the website. The website will implement a self-help version of ACT. Participants will be asked to complete 16 brief self-help website sessions, each taking around 15-20 minutes to finish, twice a week for eight weeks. Participants assigned to the website condition will also receive coaching.The purpose of coaching will be to help participants engage with the website and adhere to the intervention. Coaching will consist of an initial phone call of 10-15 minutes followed by weekly email contact during the 8-week treatment period. Coaches will be graduate students trained in clinical psychology.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hoarding Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned with equal likelihood to receive the website and coaching immediately or to wait for 12 weeks before using the website.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACT Website and Coaching Condition
Arm Type
Experimental
Arm Description
Participants will be asked to complete 16 brief self-help website sessions, each taking around 15-20 minutes to finish, twice a week for eight weeks. Website exercises and examples primarily focus on hoarding, although some examples also discuss related mental health concerns such as anxiety, low mood, health behaviors, etc. The sessions use multimedia and are interactive. Participants assigned to the website condition will also receive coaching. The purpose of coaching will be to help participants engage with the website and adhere to the intervention. Coaching will consist of an initial phone call of 10-15 minutes followed by weekly email contact during the 8-week treatment period. Coaches will be graduate students trained in clinical psychology.
Arm Title
Waitlist Condition
Arm Type
No Intervention
Arm Description
Participants assigned to the waitlist will be asked to wait 12 weeks without intervention (access to the website or coaching). They will receive access to the website after 12 weeks, but supportive coaching will not be provided to waitlist participants.
Intervention Type
Behavioral
Intervention Name(s)
ACT Website and Coaching
Intervention Description
The ACT website includes sixteen sessions and is designed to teach a series of skills from ACT applied to hoarding. The intervention also includes brief supportive coaching (an initial phone call and weekly support over email).
Primary Outcome Measure Information:
Title
Saving Inventory-Revised (SI-R; Frost et al., 2004)
Description
A self-report measure of hoarding symptoms
Time Frame
Posttreatment (8 weeks after baseline)
Secondary Outcome Measure Information:
Title
Sheehan Disability Scale (Sheehan, Harnett-Sheehan, & Raj, 1996)
Description
A self-report measure of functional impairment due to symptoms. Higher scores indicate greater impairment. Scores range from 0 to 30.
Time Frame
Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
Title
Clinical Global Impression - Improvement (CGI-I; Guy, 1976).
Description
A self-report measure of overall improvement in symptoms
Time Frame
Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
Title
General Health Questionnaire-12 (GHQ-12; Goldberg, 1978)
Description
A self-report measure of overall psychological distress
Time Frame
Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
Title
Stigma of hoarding items (Chasson et al., 2018)
Description
Seven self-report items assessing stigma towards individuals with hoarding disorder. These items are not a standardized scale but have been used in previous research (Chasson et al., 2018). Three items assess perceived difference (Example: How like or unlike do you think is a person with obsessive-compulsive disorder compared to everyone else in the general population?), three items assess disdain (Example: How good or bad do you think is a person with hoarding disorder compared to everyone else in the general population?) and one item assesses blame: How responsible do you think a person with serious mental illness is for his or her condition?
Time Frame
Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
Title
Acceptance and Action Questionnaire for Hoarding (AAQH; Krafft et al., in press)
Description
A self-report measure of hoarding-related psychological inflexibility
Time Frame
Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
Title
Five-Facet Mindfulness Questionnaire - Acting with Awareness (FFMQ-AA; Baer, Smith, Hopkins, Krietemeyer, & Toney, 2006)
Description
A self-report measure of the acting with awareness facet of mindfulness
Time Frame
Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
Title
Valuing Questionnaire-Progress (VQ-Progress; Smout, Davies, Burns, & Christie, 2014)
Description
A self-report measure of progress toward personal values
Time Frame
Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
Title
Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000).
Description
A self-report measure of the perceived credibility of and expectations toward a treatment. Only administered to treatment condition
Time Frame
After using first website session (approximately 0-1 weeks after baseline)
Title
System Usability Scale (Tullis & Albert, 2008)
Description
A self-report measure of usability of a technological system. Only administered to treatment condition. High scores indicated greater usability, and scores range from 0 to 100.
Time Frame
Posttreatment (8 weeks after baseline)
Title
Treatment Evaluation Inventory-Short Form (TEI-SF; Kelley, Heffer, Gresham, & Elliott, 1989).
Description
A self-report measure of treatment acceptability. Only administered to treatment condition
Time Frame
Posttreatment (8 weeks after baseline)
Title
Novel satisfaction item 1
Description
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "Overall, I was satisfied with the quality of the program." This is a novel satisfaction item specific to this study. Only administered to treatment condition
Time Frame
Posttreatment (8 weeks after baseline)
Title
Novel satisfaction item 2
Description
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "The program was helpful to me." This is a novel satisfaction item specific to this study. Only administered to treatment condition
Time Frame
Posttreatment (8 weeks after baseline)
Title
Novel satisfaction item 3
Description
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "The program was easy to use." This is a novel satisfaction item specific to this study. Only administered to treatment condition
Time Frame
Posttreatment (8 weeks after baseline)
Title
Novel satisfaction item 4
Description
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "I felt the program was made for someone like me." This is a novel satisfaction item specific to this study. Only administered to treatment condition
Time Frame
Posttreatment (8 weeks after baseline)
Title
Novel satisfaction item 5
Description
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "I would recommend the program to other people with a clutter and/or hoarding problem." This is a novel satisfaction item specific to this study. Only administered to treatment condition
Time Frame
Posttreatment (8 weeks after baseline)
Title
Novel satisfaction item 6
Description
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "The psychological skills taught (ex. mindfulness, opening up) were helpful to me." This is a novel satisfaction item specific to this study. Only administered to treatment condition
Time Frame
Posttreatment (8 weeks after baseline)
Title
Novel satisfaction item 7
Description
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "The practice exercises (ex. discarding, goal setting) were helpful to me." This is a novel satisfaction item specific to this study. Only administered to treatment condition
Time Frame
Posttreatment (8 weeks after baseline)
Title
Novel satisfaction item 8
Description
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "This treatment fit well with my goals." This is a novel satisfaction item specific to this study. Only administered to treatment condition
Time Frame
Posttreatment (8 weeks after baseline)
Title
Novel satisfaction item 9
Description
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "Overall, I was satisfied with the coaching that I received." This is a novel satisfaction item specific to this study. Only administered to treatment condition
Time Frame
Posttreatment (8 weeks after baseline)
Title
Novel satisfaction item 10
Description
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "The website would have been just as useful without a coach." This is a novel satisfaction item specific to this study. Only administered to treatment condition
Time Frame
Posttreatment (8 weeks after baseline)
Title
Novel satisfaction item 11
Description
Participants will be asked an open-ended question to gather qualitative feedback on the intervention. Only assigned to treatment condition. The question is, "What did you like best about the Making Space program?"
Time Frame
Posttreatment (8 weeks after baseline)
Title
Novel satisfaction item 12
Description
Participants will be asked an open-ended question to gather qualitative feedback on the intervention. Only assigned to treatment condition. The question is, "What was the most important thing you learned from the Making Space program?"
Time Frame
Posttreatment (8 weeks after baseline)
Title
Novel satisfaction item 13
Description
Participants will be asked an open-ended question to gather qualitative feedback on the intervention. Only assigned to treatment condition. The question is, "What did you like least about the Making Space Program? Why did you like this the least?"
Time Frame
Posttreatment (8 weeks after baseline)
Title
Novel satisfaction item 14
Description
Participants will be asked an open-ended question to gather qualitative feedback on the intervention. Only assigned to treatment condition. The question is, "Do you have any other comments or suggestions regarding our Making Space program?"
Time Frame
Posttreatment (8 weeks after baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years old or older Living in the USA Seeking help for clutter and/or hoarding Interested in testing a self-help website Scoring at or above the clinical cutoff of 41 on the Saving Inventory-Revised Exclusion Criteria: 17 years or younger Living outside the USA Not seeking help for clutter and/or hoarding Not interested in testing a self-help website Scoring below 41 on the Saving Inventory-Revised
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael E Levin, PhD
Organizational Affiliation
Utah State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Utah State University
City
Logan
State/Province
Utah
ZIP/Postal Code
84322
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
15350856
Citation
Frost RO, Steketee G, Grisham J. Measurement of compulsive hoarding: saving inventory-revised. Behav Res Ther. 2004 Oct;42(10):1163-82. doi: 10.1016/j.brat.2003.07.006.
Results Reference
background
PubMed Identifier
8923116
Citation
Sheehan DV, Harnett-Sheehan K, Raj BA. The measurement of disability. Int Clin Psychopharmacol. 1996 Jun;11 Suppl 3:89-95. doi: 10.1097/00004850-199606003-00015.
Results Reference
background
Citation
Guy, W. (1976). Clinical Global Impressions ECDEU Assessment Manual for Psychopharmacology, Revised (DHEW Publ. No. ADM 76-338). Rockville, MD: National Institute of Mental Health.
Results Reference
background
Citation
Goldberg, D. (1978). Manual of the GHQ. Windsor: NFER.
Results Reference
background
Citation
Chasson, G. S., Guy, A. A., Bates, S., & Corrigan, P. W. (2018). They aren't like me, they are bad, and they are to blame: A theoretically-informed study of stigma of hoarding disorder and obsessive-compulsive disorder. Journal of Obsessive-Compulsive and Related Disorders, 16, 56-65. http://doi.org/10.1016/j.jocrd.2017.12.006
Results Reference
background
Citation
Krafft, J., Ong, C. W., Twohig, M. P., & Levin, M. E. (In press). Assessing psychological inflexibility in hoarding: The Acceptance and Action Questionnaire for Hoarding (AAQH). Journal of Contextual Behavioral Science.http://doi.org/10.1016/j.jcbs.2018.08.003
Results Reference
background
PubMed Identifier
16443717
Citation
Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.
Results Reference
background
Citation
Smout, M., Davies, M., Burns, N., & Christie, A. (2014). Development of the Valuing Questionnaire (VQ). Journal of Contextual Behavioral Science, 3, 164-172. http://doi.org/10.1016/j.jcbs.2014.06.001
Results Reference
background
PubMed Identifier
11132119
Citation
Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
Results Reference
background
Citation
Tullis, T., & Albert, W. (2008). Measuring the user experience. San Francisco, CA: Morgan Kaufmann.
Results Reference
background
Citation
Kelley, M. L., Heffer, R. W., Gresham, F. M., & Elliott, S. N. (1989). Development of a modified treatment evaluation inventory. Journal of Psychopathology and Behavioral Assessment, 11, 235-247.
Results Reference
background

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Web-based Acceptance and Commitment Therapy for Hoarding Disorder

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