Clinical trial NCT03725163: Telepsychotherapy for the Treatment of Adolescents With Trichotillomania
Official title: Telepsychotherapy for the Treatment of Adolescents With Trichotillomania
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trichotillomania
Keywords: Trichotillomania
Adolescents
Telepsychotherapy
AEBT
ACT
Lead sponsor: Utah State University
Sponsor class: OTHER
First posted: 2018-10-30
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: The investigators of this study plan to recruit 60 participants, 30 adolescents and 30 parents or legal guardians. This number will provide adequate power (0.70) to detect a large effect size (d=.81). All portions of this study will be completed online using teleconferencing software, Zoom (similar to Skype).

Participants will be randomized into either a treatment or waitlist control group. All participants will receive treatment, however, those in the waitlist group will wait 12 weeks before beginning treatment. Treatment will consist of 10, 50 minute sessions with up to six short (10-15 minute) booster sessions during a three-month period following treatment. Participants and parents/guardians will complete full assessment batteries at intake, post-waitlist (only those in the waitlist condition), post-treatment, and 3, 6, and 12 months following treatment. Moreover, adolescent participants will be asked to track their daily pulling behavior each day while in treatment(with parent/guardian help if desired). This will be done through the use of daily text message reminders using app.eztexting.com to the parent/guardian that will include a link to the short (less then 5 minute) Qualtrics survey. All treatment sessions will take place online using video conferencing software (i.e., Zoom).

Parents/guardians will be invited to participate in the final 10 minutes of each session. This will allow for the adolescent to review what they have learned and also allow the parent/guardian to be involved in the fulfillment of treatment goals and to assist with skill-building throughout the week. Parents will also be give a short (1/2 to 1 page) handout following each session that will explain what was taught and how they can best help the participant make progress. Parents will also be asked to complete a short measure of psychological flexibility at intake, post-waitlist (only when applicable), post-treatment, and 3, 6, and 12-months following treatment.

Eligibility criteria: Inclusion Criteria:

* Meet DSM-5 criteria for trichotillomania.
* Seeking treatment primarily for trichotillomania-related concerns.
* 12-17 years old.
* Reside in Utah.
* Speak fluent English.

Parents:

* Must be fluent English speaker.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Trichotillomania Scale for Children-Chile and Parent Versions (TSC-C & TSC-p)
timeFrame: Changes in scores from baseline, 10-week post-treatment, and 3-, 6-, and 12-month follow-ups will be assessed.
measure: Acceptance and Action Questionnaire for Trichotillomania (AAQ-TTM)
timeFrame: Changes in scores from baseline, 10-week post-treatment, and 3-, 6-, and 12-month follow-ups will be assessed.
measure: Warwick-Edinburgh Mental Well-being Scale (WEBWMS)
timeFrame: Changes in scores from baseline, 10-week post-treatment, and 3-, 6-, and 12-month follow-ups will be assessed.
Secondary outcomes:
measure: Acceptance and Fusion Questionnaire for Youth (AFQ-Y8)
timeFrame: Changes in scores from baseline, 10-week post-treatment, and 3-, 6-, and 12-month follow-ups will be assessed.
measure: Youth Outcome Questionnaire (YOQ-C & YOQ-P)
timeFrame: Changes in scores from baseline, 10-week post-treatment, and 3-, 6-, and 12-month follow-ups will be assessed.
measure: Parental Acceptance Questionnaire (6-PAQ)
timeFrame: Changes in scores from baseline, 10-week post-treatment, and 3-, 6-, and 12-month follow-ups will be assessed.
Other outcomes:
Locations:
city: Logan
country: United States
facility: Utah State University
state: Utah
Study officials:
affiliation: Utah State University
name: Michael P Twohig, PhD
role: PRINCIPAL_INVESTIGATOR
References: