NCT03725163

Brief Summary

The primary purpose of the current study is to evaluate the effectiveness of providing treatment for adolescents with trichotillomania through the use of telehealth. Parent or legal guardians' psychological flexibility scores will be assessed to determine if their levels of flexibility potentially moderate treatment outcomes. The study will test the following hypotheses: Hypothesis 1: Telepsychotherapy will result in significantly better trichotillomania symptom outcomes for adolescents than a waitlist control condition. Hypothesis 2: Telepsychotherapy will result in significantly better psychological flexibility outcomes for adolescents than a waitlist control condition. Hypothesis 3: Telepsychotherapy will result in significantly better overall wellbeing outcomes for adolescents than a waitlist control condition. Hypothesis 4: Within-group changes (that include both conditions following treatment) will be significant from pre-treatment to post-treatment and will not significantly differ from post-treatment at 3, 6, and 12-month follow-up.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 30, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2020

Completed
Last Updated

October 30, 2018

Status Verified

October 1, 2018

Enrollment Period

2 years

First QC Date

October 15, 2018

Last Update Submit

October 29, 2018

Conditions

Keywords

TrichotillomaniaAdolescentsTelepsychotherapyAEBTACT

Outcome Measures

Primary Outcomes (3)

  • Trichotillomania Scale for Children-Chile and Parent Versions (TSC-C & TSC-p)

    This self-report measure can be filled out by both the adolescent and parent. This measure is broke into 2 components: severity (5 items) and distress/impairment (7 items). A total of 3 scores are obtained, one for each component and a total score. This measure provides information about symptom severity and level of impairment or distress of trichotillomania for the client. Items 1-5 represent the severity score, each item is scored 0-2 with 2 representing higher severity. Items 1-5 are summed then divided by 5 to give a severity score. Items 6-12 represent the Distress/Impairment section and follow a similar scoring format summing each item and dividing by 7 to represent the Distress/Impairment score. The Severity Score and Distress/Impairment score are summed to give a total score. The minimum value for scores can be 0, with the highest score being 4 for the total score.

    Changes in scores from baseline, 10-week post-treatment, and 3-, 6-, and 12-month follow-ups will be assessed.

  • Acceptance and Action Questionnaire for Trichotillomania (AAQ-TTM)

    This measure assesses a participant's overall levels of psychological inflexibility in relation to trichotillomania and how impairing trichotillomania may be for the individual. Each item ranges on scores from 1 (Never true) to 7 (always true). Higher scores on each item indicate higher levels of distress or psychologically inflexibility in relation to their trichotillomania. The values for each items are summed to provide a total score. Higher scores tend to indicate greater psychological flexibility. Items 2,3,4,5,7,8, and 9 are reversed scored.

    Changes in scores from baseline, 10-week post-treatment, and 3-, 6-, and 12-month follow-ups will be assessed.

  • Warwick-Edinburgh Mental Well-being Scale (WEBWMS)

    This is a 14-item Likert-type scale that measures overall well-being for participants. Each item has scores ranging from 1="None of the time" to 5 "All of the time". Higher scores indicate higher levels of overall well-being for a client.

    Changes in scores from baseline, 10-week post-treatment, and 3-, 6-, and 12-month follow-ups will be assessed.

Secondary Outcomes (3)

  • Acceptance and Fusion Questionnaire for Youth (AFQ-Y8)

    Changes in scores from baseline, 10-week post-treatment, and 3-, 6-, and 12-month follow-ups will be assessed.

  • Youth Outcome Questionnaire (YOQ-C & YOQ-P)

    Changes in scores from baseline, 10-week post-treatment, and 3-, 6-, and 12-month follow-ups will be assessed.

  • Parental Acceptance Questionnaire (6-PAQ)

    Changes in scores from baseline, 10-week post-treatment, and 3-, 6-, and 12-month follow-ups will be assessed.

Study Arms (2)

Treatment

EXPERIMENTAL

This arm will begin treatment immediately after completing the initial intake assessment.

Behavioral: Acceptance and Commitment Therapy Enhanced Behavior Therapy (AEBT)

Waitlist Control

OTHER

Participants assigned to the waitlist control condition will begin a 12-week waiting period after completing the initial intake assessment before starting treatment.

Behavioral: Acceptance and Commitment Therapy Enhanced Behavior Therapy (AEBT)

Interventions

This treatment approach blends traditional behavior therapy elements of habit reversal training and stimulus control techniques with the more contemporary behavioral elements of Acceptance and Commitment Therapy (ACT). The first phase of the treatment, clients are taught skills for stopping and preventing their unconscious pulling episodes. The second phase, clients are introduced to ACT. Unlike interventions that aim to change the type or frequency of pulling-related cognitions, this treatment uses strategies to change the function of these cognitions. Clients are taught to see urges for what they really are and to accept their pulling-related thoughts, feelings, and urges without fighting against them. Over the course of 10 session clients will learn to be aware of their pulling and warning signals, use self-management strategies for stopping and preventing pulling, stop fighting against their pulling-related urges and thoughts, and work toward increasing their quality of life.

TreatmentWaitlist Control

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Meet DSM-5 criteria for trichotillomania.
  • Seeking treatment primarily for trichotillomania-related concerns.
  • years old.
  • Reside in Utah.
  • Speak fluent English.
  • Parents:
  • Must be fluent English speaker.

You may not qualify if:

  • Currently receiving psychotherapy.
  • Started or changed psychotropic medication in the past 30 days.
  • Planning to start or change psychotropic medication during the course of the current study.
  • Completed high school.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Utah State University

Logan, Utah, 84322, United States

RECRUITING

MeSH Terms

Conditions

Trichotillomania

Condition Hierarchy (Ancestors)

Obsessive-Compulsive DisorderAnxiety DisordersMental DisordersDisruptive, Impulse Control, and Conduct Disorders

Study Officials

  • Michael P Twohig, PhD

    Utah State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized using block randomization to be assigned to a waitlist control condition or the treatment condition. Participants assigned to the waitlist control will have a 12-week waiting period prior to starting treatment. Those assigned to the treatment condition will begin therapy immediately.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 15, 2018

First Posted

October 30, 2018

Study Start

August 6, 2018

Primary Completion

August 5, 2020

Study Completion

August 5, 2020

Last Updated

October 30, 2018

Record last verified: 2018-10

Locations