- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04239729
Web-based Acceptance and Commitment Therapy for Hoarding Disorder
April 26, 2021 updated by: Utah State University
A Randomized Waitlist-controlled Trial of Web-based Acceptance and Commitment Therapy for Hoarding Disorder
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Utah
-
Logan, Utah, United States, 84322
- Utah State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: ACT Website and Coaching Condition
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.
|
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).
|
NO_INTERVENTION: Waitlist Condition
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Saving Inventory-Revised (SI-R; Frost et al., 2004)
Time Frame: Posttreatment (8 weeks after baseline)
|
A self-report measure of hoarding symptoms
|
Posttreatment (8 weeks after baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sheehan Disability Scale (Sheehan, Harnett-Sheehan, & Raj, 1996)
Time Frame: Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
|
A self-report measure of functional impairment due to symptoms.
Higher scores indicate greater impairment.
Scores range from 0 to 30.
|
Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
|
Clinical Global Impression - Improvement (CGI-I; Guy, 1976).
Time Frame: Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
|
A self-report measure of overall improvement in symptoms
|
Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
|
General Health Questionnaire-12 (GHQ-12; Goldberg, 1978)
Time Frame: Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
|
A self-report measure of overall psychological distress
|
Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
|
Stigma of hoarding items (Chasson et al., 2018)
Time Frame: Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
|
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?
|
Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
|
Acceptance and Action Questionnaire for Hoarding (AAQH; Krafft et al., in press)
Time Frame: Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
|
A self-report measure of hoarding-related psychological inflexibility
|
Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
|
Five-Facet Mindfulness Questionnaire - Acting with Awareness (FFMQ-AA; Baer, Smith, Hopkins, Krietemeyer, & Toney, 2006)
Time Frame: Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
|
A self-report measure of the acting with awareness facet of mindfulness
|
Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
|
Valuing Questionnaire-Progress (VQ-Progress; Smout, Davies, Burns, & Christie, 2014)
Time Frame: Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
|
A self-report measure of progress toward personal values
|
Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
|
Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000).
Time Frame: After using first website session (approximately 0-1 weeks after baseline)
|
A self-report measure of the perceived credibility of and expectations toward a treatment.
Only administered to treatment condition
|
After using first website session (approximately 0-1 weeks after baseline)
|
System Usability Scale (Tullis & Albert, 2008)
Time Frame: Posttreatment (8 weeks after baseline)
|
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.
|
Posttreatment (8 weeks after baseline)
|
Treatment Evaluation Inventory-Short Form (TEI-SF; Kelley, Heffer, Gresham, & Elliott, 1989).
Time Frame: Posttreatment (8 weeks after baseline)
|
A self-report measure of treatment acceptability.
Only administered to treatment condition
|
Posttreatment (8 weeks after baseline)
|
Novel satisfaction item 1
Time Frame: Posttreatment (8 weeks after baseline)
|
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
|
Posttreatment (8 weeks after baseline)
|
Novel satisfaction item 2
Time Frame: Posttreatment (8 weeks after baseline)
|
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
|
Posttreatment (8 weeks after baseline)
|
Novel satisfaction item 3
Time Frame: Posttreatment (8 weeks after baseline)
|
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
|
Posttreatment (8 weeks after baseline)
|
Novel satisfaction item 4
Time Frame: Posttreatment (8 weeks after baseline)
|
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
|
Posttreatment (8 weeks after baseline)
|
Novel satisfaction item 5
Time Frame: Posttreatment (8 weeks after baseline)
|
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
|
Posttreatment (8 weeks after baseline)
|
Novel satisfaction item 6
Time Frame: Posttreatment (8 weeks after baseline)
|
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
|
Posttreatment (8 weeks after baseline)
|
Novel satisfaction item 7
Time Frame: Posttreatment (8 weeks after baseline)
|
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
|
Posttreatment (8 weeks after baseline)
|
Novel satisfaction item 8
Time Frame: Posttreatment (8 weeks after baseline)
|
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
|
Posttreatment (8 weeks after baseline)
|
Novel satisfaction item 9
Time Frame: Posttreatment (8 weeks after baseline)
|
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
|
Posttreatment (8 weeks after baseline)
|
Novel satisfaction item 10
Time Frame: Posttreatment (8 weeks after baseline)
|
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
|
Posttreatment (8 weeks after baseline)
|
Novel satisfaction item 11
Time Frame: Posttreatment (8 weeks after baseline)
|
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?"
|
Posttreatment (8 weeks after baseline)
|
Novel satisfaction item 12
Time Frame: Posttreatment (8 weeks after baseline)
|
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?"
|
Posttreatment (8 weeks after baseline)
|
Novel satisfaction item 13
Time Frame: Posttreatment (8 weeks after baseline)
|
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?"
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Posttreatment (8 weeks after baseline)
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Novel satisfaction item 14
Time Frame: Posttreatment (8 weeks after baseline)
|
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?"
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Posttreatment (8 weeks after baseline)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael E Levin, PhD, Utah State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Goldberg, D. (1978). Manual of the GHQ. Windsor: NFER.
- 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
- 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
- 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
- Tullis, T., & Albert, W. (2008). Measuring the user experience. San Francisco, CA: Morgan Kaufmann.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 17, 2020
Primary Completion (ACTUAL)
November 27, 2020
Study Completion (ACTUAL)
November 27, 2020
Study Registration Dates
First Submitted
January 13, 2020
First Submitted That Met QC Criteria
January 22, 2020
First Posted (ACTUAL)
January 27, 2020
Study Record Updates
Last Update Posted (ACTUAL)
April 27, 2021
Last Update Submitted That Met QC Criteria
April 26, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10223
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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