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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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).
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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?"
Posttreatment (8 weeks after baseline)
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?"
Posttreatment (8 weeks after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Utah State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 17, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 27, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 27, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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