A RCT of a Fully-automated Self-help AEBT Website

NCT ID: NCT05610839

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-08

Study Completion Date

2023-09-29

Brief Summary

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Trichotillomania (TTM) is characterized by hair pulling that is repetitive in nature leading to notable hair loss, causing clinically significant distress and resulting in impairments across social and functional domains (APA, 2013). Trichotillomania causes significant social impairment including affecting close relationships, pursuing occupational changes or advancement, or interfering with schooling (Grant et al., 2017; Woods, Flessner, Franklin, Wetterneck, et al., 2006). The core of the treatment of trichotillomania has traditionally been Habit Reversal Training (HRT) (Twohig, Bluett, et al., 2014). Another form of treatment that is gaining empirical support is Acceptance and Commitment Therapy (ACT) which has been studied in four randomized controlled trials, one studying ACT as a standalone treatment (Lee, Homan, et al., 2018), and three examining ACT combined with HRT (Twohig et al., 2021; Lee, Haeger, et al., 2018; Woods, Wetterneck, et al., 2006) which demonstrated efficacy of the combined treatment in decreasing pulling symptom severity.

The prevalence of trichotillomania in the US is 1-2% of the population and yet treatment access is limited by many issues including processionals' lack of knowledge of the disorder and low treatment accessibility (Walther et al., 2010). ACT- enhanced behavior therapy has been implemented using telehealth to reach a larger population (42.2% decrease pre-to-post treatment), but telehealth still requires therapist time and incurs notable costs (Lee, Haeger, et al., 2018). The present study aims to address the gap in trichotillomania treatment accessibility by examining the role of check-ins on adherence and efficacy on afully automated, web-based ACT-enhanced HRT treatment for adults with trichotillomania across the United States. We predict that the condition with check-ins will increase adherence and efficacy of the treatment significantly more than the condition without check-ins. Additionally, we predict that hair pulling severity and psychological flexibility will be significantly improved by the condition with check-ins compared to the condition without check-ins.

Detailed Description

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Conditions

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AEBT Website With Check-ins AEBT Website Without Check-ins

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AEBT website with check-ins

Participants will complete the 8-module intervention of Acceptance-enhanced behavior therapy (AEBT) and will receive weekly check-ins. Acceptance-enhanced behavior therapy is a manualized treatment approach created by Woods and Twohig 2008 that provides both Acceptance and Commitment Therapy and Habit Reversal Therapy.

Group Type EXPERIMENTAL

Acceptance-Enhanced Behavior Therapy

Intervention Type BEHAVIORAL

8-module intervention delivering acceptance-enhanced behavior therapy through a fully automated website. This intervention was adapted from the Acceptance-enhanced behavior therapy workbook (Woods \& Twohig, 2008).

AEBT website without check-ins

Participants will complete the 8-module intervention of Acceptance-enhanced behavior therapy (AEBT) but will not receive weekly check-ins. Acceptance-enhanced behavior therapy is a manualized treatment approach created by Woods and Twohig 2008 that provides both Acceptance and Commitment Therapy and Habit Reversal Therapy.

Group Type ACTIVE_COMPARATOR

Acceptance-Enhanced Behavior Therapy

Intervention Type BEHAVIORAL

8-module intervention delivering acceptance-enhanced behavior therapy through a fully automated website. This intervention was adapted from the Acceptance-enhanced behavior therapy workbook (Woods \& Twohig, 2008).

Interventions

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Acceptance-Enhanced Behavior Therapy

8-module intervention delivering acceptance-enhanced behavior therapy through a fully automated website. This intervention was adapted from the Acceptance-enhanced behavior therapy workbook (Woods \& Twohig, 2008).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Currently meet DSM-5 criteria for trichotillomania
2. searching for trichotillomania-based treatment
3. are atleast 18 years old
4. fluent English speakers
5. living in the U.S.

Exclusion Criteria

1. currently receiving alternative therapy
2. currently modifying or starting psychotropic medication
3. previously met DSM-5 criteria for trichotillomania but are not, at the time of intake session, engaging in hair pulling
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Utah State University

OTHER

Sponsor Role lead

Responsible Party

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Michael Twohig, Ph.D.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Utah State University

Logan, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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13026

Identifier Type: -

Identifier Source: org_study_id