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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06108245
Other study ID # IRB-23-253
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date October 31, 2024

Study information

Verified date February 2024
Source Mississippi State University
Contact Jennifer Krafft, PhD
Phone +1 (662) 325-7490
Email jek299@msstate.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to investigate whether values clarification writing prompts administered via a prototype mobile application can help enhance motivation and facilitate decluttering in individuals with hoarding problems. This randomized control trial will help to (1) assess whether values clarification can improve outcomes in hoarding treatment by increasing motivation, (2) clarify which specific values clarification procedures are most beneficial, and (3) evaluate the impact of values clarification on overall symptoms and well-being. Participants will be randomly assigned to either the experimental group (receiving the values clarification intervention), psychological placebo group (self-reflection intervention), or the no intervention waitlist group.


Description:

This randomized control trial study aims to investigate the efficacy of a values clarification prototype mobile application intervention in enhancing motivation and facilitating decluttering in individuals with clinical levels of hoarding symptoms. Participants will be recruited using a variety of recruitment methods (e.g., Google Ads, posts on relevant online groups such as Facebook groups, posting flyers, and provider referrals). Interested participants will first complete a pre-screen asking about their age, country of residence, and whether they own an appropriate mobile device (i.e. iOS or Android). Eligible participants, who must be at least 18 years old and residing in the United States, will be provided with a consent form to sign and then directed to further screening to determine whether they meet the clinical cutoff for hoarding symptoms. Individuals who decline to participate or are screened as ineligible will be screened out and provided with a brief list of other resources they may access for clutter/hoarding problems. Individuals who consent and are screened as eligible will be redirected to complete a baseline survey and then randomly assigned to one of three groups with equal probability: (1) Experimental group with the values clarification mobile application, (2) psychological placebo group with the self-reflection mobile application, and (3) no-treatment waitlist group. Four weeks after baseline, participants will be asked to complete a post-treatment survey and eight weeks after baseline, participants will be asked to complete a final, follow-up survey. The no-treatment waitlist participants will be given the opportunity to download and use either prototype mobile app, and participants assigned to use one of the apps will be given the opportunity to use the alternative app.


Recruitment information / eligibility

Status Recruiting
Enrollment 124
Est. completion date October 31, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. 18 years or older. 2. Living in the USA. 3. Owning an Android or iOS mobile device. 4. Meeting the clinical cutoff scores for the Saving Inventory-Revised and Clutter Image Rating scales. 5. Seeking help for clutter and/or hoarding. 6. Interested in testing a self-help prototype mobile app intervention. Exclusion Criteria: 1. 17 years or younger. 2. Living outside the USA. 3. Not owning an Android or iOS mobile device. 4. Scoring below the clinical cutoff scores for the Saving Inventory-Revised and Clutter Image Rating scales. 5. Not seeking help for clutter and/or hoarding. 6. Not interested in testing a self-help prototype mobile app intervention. 7. Not having the fluency in English sufficient to understand study materials.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Values Clarification Mobile Application
Participants in the intervention group will be asked to answer a series of values clarification writing prompts twice a day over four weeks.
Self-Reflection Mobile Application
Participants in the psychological placebo group will be administered writing prompts in the same format and frequency as the values intervention, but with prompts focused on self-reflection related to clutter and organization.

Locations

Country Name City State
United States Mindfulness and Acceptance Processes Lab Starkville Mississippi

Sponsors (1)

Lead Sponsor Collaborator
Mississippi State University

Country where clinical trial is conducted

United States, 

References & Publications (14)

Bangor, A., Kortum, P. T., & Miller, J. T. (2008). An empirical evaluation of the system usability scale. Intl. Journal of Human-Computer Interaction, 24(6), 574-594.

Brooke, J. (1996). SUS: A "quick and dirty" usability scale. In P. W. Jordan, B. Thomas, B. A. Weerdmeester, & I. L. McClelland (Eds.), Usability evaluation in industry (pp. 189-194). Taylor & Francis.

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. — View Citation

Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13. — View Citation

Frost RO, Hristova V, Steketee G, Tolin DF. Activities of Daily Living Scale in Hoarding Disorder. J Obsessive Compuls Relat Disord. 2013 Apr 1;2(2):85-90. doi: 10.1016/j.jocrd.2012.12.004. Epub 2012 Dec 25. — View 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. — View Citation

Frost, R. O., Steketee, G., Tolin, D. F., & Renaud, S. (2008). Development and validation of the clutter image rating. Journal of Psychopathology and Behavioral Assessment, 30, 193-203.

Henry JD, Crawford JR. The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005 Jun;44(Pt 2):227-39. doi: 10.1348/014466505X29657. — View 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.

Krafft, J., & Levin, M. E. (2021). Does the Cognitive Fusion Questionnaire measure more than frequency of negative thoughts?. Journal of Contextual Behavioral Science, 22, 63-67.

Krafft, J., Ong, C. W., Twohig, M. P., & Levin, M. E. (2019). Assessing psychological inflexibility in hoarding: The Acceptance and Action Questionnaire for Hoarding (AAQH). Journal of Contextual Behavioral Science, 12, 234-242.

McLoughlin, S., Stapleton, A., & Hochard, K. D. (2022). Development and preliminary validation of the Value Clarity Questionnaire. PsyArXiv. https://doi.org/10.31234/osf.io/u97q3

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. — View Citation

Smout, M., Davies, M., Burns, N., & Christie, A. (2014). Development of the valuing questionnaire (VQ). Journal of Contextual Behavioral Science, 3(3), 164-172.

* Note: There are 14 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 grouped into three factors: excessive acquisition, difficulty discarding, and clutter. The SI-R consists of 23 items that are rated on a scale from 0 (e.g., no distress) to 4 (e.g., extreme distress). Scores range from 0 to 92, with higher scores indicate greater endorsement of hoarding disorder symptoms. Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
Secondary Clutter Image Rating (CIR; Frost et al., 2008) A self-report measure of clutter. Participants are presented with nine pictures of three rooms (kitchen, bedroom, and living room) in progressively increasing stages of clutter and are asked to pick the picture that most resembles their living space. Participants scores can range from 1 (picture #1) to 9 (picture #9) per room, with higher numbers indicating rooms with greater levels of clutter. Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
Secondary Sheehan Disability Scale (Sheehan, Harnett-Sheehan, & Raj, 1996) A self-report measure of functional impairment due to symptoms. It consists of 3 items rated on a scale from 0 (not at all) to 10 (extremely). Scores range from 0 to 30, with higher scores indicate greater impairment. This measure has been adapted to ask about disability related to hoarding. Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
Secondary Activities of Daily Living in Hoarding Scale (ADL-H; Frost et al., 2013) A self-report measure of activities impaired by hoarding disorder. The ADL-H consists of 15 items rated on a scale from 0 (can do it easily) to 5 (unable to do). A "not applicable" response option is also provided. Total scores range from a minimum of 0 to a maximum of 75, with higher scores indicating greater impairment. Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
Secondary Values Clarity Questionnaire (VCQ; McLoughlin et al., unpublished manuscript) A self-report scale that measures how well respondents understand and can articulate their values. The VCQ consists of 7 items rated on a scale from 1 (strongly disagree) to 5 (strongly agree). Total scores range from a minimum of 7 to a maximum of 35, with higher scores indicating higher levels of clarity, understanding, and articulation of one's own values. Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
Secondary Valuing Questionnaire (VQ; Smout et al., 2013) A self-report questionnaire that measures the extent to which one is living in accordance with their values. The VQ consists of 10 items rated on a scale from 0 (not at all true) to 6 (completely true). Total scores range from 0 to 60, with higher scores indicating greater valued living. Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
Secondary Acceptance and Action Questionnaire for Hoarding (AAQH; Krafft et al., 2019) A self-report measure of hoarding-related psychological inflexibility. The AAQH consists of 14 items rated on a scale from 1 (never true) to 7 (always true). Total scores range from 14 to 98, with higher scores indicating greater hoarding-related psychological inflexibility. Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
Secondary Depression, Anxiety, and Stress Scales (DASS-21; Henry & Crawford, 2005) A self-report measure of symptoms related to depression, anxiety, and stress. The DASS-21 consists of 21 items rated on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Total scores range from 0 to 63, with higher scores indicating greater endorsement of depression, anxiety, and stress related symptoms. Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
Secondary Satisfaction with Life Scale (SWLS; Diener et al., 1985) A self-report measure assessing one's satisfaction with their life as a whole. The SWLS consists of 5 items rated on a scale from 1 (strongly disagree) to 7 (strongly agree). Scores range from 5 to 35, with higher scores indicating greater life satisfaction. Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
Secondary Random responding question (used in e.g. Krafft & Levin, 2021) Participants will be asked to choose one of the following statements that best describe their participation in the survey, noting that their answer does not impact their participation in the study in any way: "I answered every question carefully and honestly" (1); "I answered most questions carefully and honestly" (2); "I randomly responded and/or did not respond honestly to about half of the questions"(3); "I randomly responded and/or did not respond honestly to most questions"(4); and "I randomly responded and/or did not respond honestly to any questions"(5). Participants who score a 4 or 5 will be screened out for random responding. Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
Secondary Treatment Evaluation Inventory-Short Form (TEI-SF; Kelley et al., 1989) A self-report measure of treatment acceptability. Only administered to the experimental and placebo conditions.The TEI-SF consists of 7 items rated from 1 (strongly disagree) to 5 (strongly agree). Scores range from 7 to 35, with higher scores indicating higher levels of endorsement for treatment acceptability. Posttreatment (4 weeks after baseline)
Secondary System Usability Scale (SUS; Bangor et al., 2008) A self-report measure of usability of a technological system. The SUS consists of 10 items rated on a scale from 1 (strongly disagree) to 5 (strongly agree). Scores are summed and doubled such that they range from 0 to 100 (as per the official scoring instructions), with high scores indicated greater usability. Only administered to the experimental and placebo conditions. Posttreatment (4 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 the experimental and placebo conditions. The CEQ consists of 6 items, 3 for Credibility and 3 for Expectancy. An average score ranging from 1 to 9 will be calculated for Credibility, with higher scores a greater perception of the intervention's credibility by the participants. For the expectancy component, an average percentage score will be calculated ranging from 0% to 100%, with higher percentages indicating more positive expectations towards the treatment. After using first website session (approximately 0-1 weeks after baseline)
Secondary Novel satisfaction item 1 Participants will be asked an open-ended question to gather qualitative feedback on the intervention. Only assigned to the experimental and placebo conditions. The question is, "What did you like best about the prototype mobile app?" Posttreatment (4 weeks after baseline)
Secondary Novel satisfaction item 2 Participants will be asked an open-ended question to gather qualitative feedback on the intervention. Only administered to the experimental and placebo conditions. The question is, "What was the most important thing you learned from the mobile app?" Posttreatment (4 weeks after baseline)
Secondary Novel satisfaction item 3 Participants will be asked an open-ended question to gather qualitative feedback on the intervention. Only assigned to the experimental and placebo conditions. The question is, "What did you like least about the mobile app? Why did you like this the least?" Posttreatment (4 weeks after baseline)
Secondary Novel satisfaction item 4 Participants will be asked an open-ended question to gather qualitative feedback on the intervention. Only assigned to the experimental and placebo conditions. The question is, "Do you have any other comments or suggestions regarding the mobile app?" Posttreatment (4 weeks after baseline)
See also
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