Telepsychotherapy for the Treatment of Adolescents With Trichotillomania

NCT ID: NCT03725163

Last Updated: 2018-10-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-06
• Study Completion Date: 2020-08-05

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.

Conditions

Trichotillomania

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

Acceptance and Commitment Therapy Enhanced Behavior Therapy (AEBT)

Intervention Type: BEHAVIORAL

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.

Waitlist Control

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

Group Type: OTHER

Acceptance and Commitment Therapy Enhanced Behavior Therapy (AEBT)

Intervention Type: BEHAVIORAL

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.

Interventions

Acceptance and Commitment Therapy Enhanced Behavior Therapy (AEBT)

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Utah State University

OTHER

Sponsor Role: lead

Responsible Party

Michael Twohig, Ph.D.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael P Twohig, PhD

Role: PRINCIPAL_INVESTIGATOR

Utah State University

Locations

Utah State University

Logan, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jeremiah E Fruge, BA

Role: CONTACT

jeremiah.fruge@aggiemail.usu.edu

435-797-8303

Other Identifiers

9153

Identifier Type: -

Identifier Source: org_study_id