Telepsychotherapy for the Treatment of Adolescents With Trichotillomania
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Trichotillomania Scale for Children-Chile and Parent Versions (TSC-C & TSC-p)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet DSM-5 criteria for trichotillomania.
- •Seeking treatment primarily for trichotillomania-related concerns.
- •12-17 years old.
- •Reside in Utah.
- •Speak fluent English.
- •Must be fluent English speaker.
排除标准
- •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.
研究组 & 干预措施
Treatment
This arm will begin treatment immediately after completing the initial intake assessment.
干预措施: Acceptance and Commitment Therapy Enhanced Behavior Therapy (AEBT) (Behavioral)
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.
干预措施: Acceptance and Commitment Therapy Enhanced Behavior Therapy (AEBT) (Behavioral)
结局指标
主要结局
Trichotillomania Scale for Children-Chile and Parent Versions (TSC-C & TSC-p)
时间窗: Changes in scores from baseline, 10-week post-treatment, and 3-, 6-, and 12-month follow-ups will be assessed.
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.
Acceptance and Action Questionnaire for Trichotillomania (AAQ-TTM)
时间窗: Changes in scores from baseline, 10-week post-treatment, and 3-, 6-, and 12-month follow-ups will be assessed.
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.
Warwick-Edinburgh Mental Well-being Scale (WEBWMS)
时间窗: Changes in scores from baseline, 10-week post-treatment, and 3-, 6-, and 12-month follow-ups will be assessed.
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.
次要结局
- 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.)
研究者
Michael Twohig, Ph.D.
Professor
Utah State University