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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04239729
Other study ID # 10223
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 17, 2020
Est. completion date November 27, 2020

Study information

Verified date April 2021
Source Utah State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date November 27, 2020
Est. primary completion date November 27, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
ACT Website and Coaching
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).

Locations

Country Name City State
United States Utah State University Logan Utah

Sponsors (1)

Lead Sponsor Collaborator
Utah State University

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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

Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. — View Citation

Frost RO, Steketee G, Grisham J. Measurement of compulsive hoarding: saving inventory-revised. Behav Res Ther. 2004 Oct;42(10):1163-82. — View Citation

Goldberg, D. (1978). Manual of the GHQ. Windsor: NFER.

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.

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.

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

Sheehan DV, Harnett-Sheehan K, Raj BA. The measurement of disability. Int Clin Psychopharmacol. 1996 Jun;11 Suppl 3:89-95. Review. — View 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

Tullis, T., & Albert, W. (2008). Measuring the user experience. San Francisco, CA: Morgan Kaufmann.

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Saving Inventory-Revised (SI-R; Frost et al., 2004) A self-report measure of hoarding symptoms Posttreatment (8 weeks after baseline)
Secondary 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. Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
Secondary Clinical Global Impression - Improvement (CGI-I; Guy, 1976). A self-report measure of overall improvement in symptoms Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
Secondary General Health Questionnaire-12 (GHQ-12; Goldberg, 1978) A self-report measure of overall psychological distress Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
Secondary 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? Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
Secondary Acceptance and Action Questionnaire for Hoarding (AAQH; Krafft et al., in press) A self-report measure of hoarding-related psychological inflexibility Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
Secondary 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 Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
Secondary Valuing Questionnaire-Progress (VQ-Progress; Smout, Davies, Burns, & Christie, 2014) A self-report measure of progress toward personal values Posttreatment (8 weeks after baseline) and follow-up (12 weeks after baseline)
Secondary 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 After using first website session (approximately 0-1 weeks after baseline)
Secondary 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. Posttreatment (8 weeks after baseline)
Secondary Treatment Evaluation Inventory-Short Form (TEI-SF; Kelley, Heffer, Gresham, & Elliott, 1989). A self-report measure of treatment acceptability. Only administered to treatment condition Posttreatment (8 weeks after baseline)
Secondary 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 Posttreatment (8 weeks after baseline)
Secondary 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 Posttreatment (8 weeks after baseline)
Secondary 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 Posttreatment (8 weeks after baseline)
Secondary 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 Posttreatment (8 weeks after baseline)
Secondary 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 Posttreatment (8 weeks after baseline)
Secondary 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 Posttreatment (8 weeks after baseline)
Secondary 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 Posttreatment (8 weeks after baseline)
Secondary 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 Posttreatment (8 weeks after baseline)
Secondary 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 Posttreatment (8 weeks after baseline)
Secondary 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 Posttreatment (8 weeks after baseline)
Secondary 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?" Posttreatment (8 weeks after baseline)
Secondary 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?" Posttreatment (8 weeks after baseline)
Secondary 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?" Posttreatment (8 weeks after baseline)
Secondary 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?" Posttreatment (8 weeks after baseline)
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