TrichotillomaniaNCT03725163
Telepsychotherapy for the Treatment of Adolescents With Trichotillomania
A study testing Acceptance and Commitment Therapy Enhanced Behavior Therapy (AEBT) in people with Trichotillomania, run by Utah State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Trichotillomania
- What is being tested?
- Acceptance and Commitment Therapy Enhanced Behavior Therapy (AEBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2018to 5 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Utah State University
Logan, Utah, 84322
About this study
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:
Read more
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.
Read the 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
- Being tested
- Acceptance and Commitment Therapy Enhanced Behavior Therapy (AEBT)
- Keywords
- Trichotillomania, Adolescents, Telepsychotherapy, AEBT, ACT
- Medical subject headings
- Trichotillomania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy Enhanced Behavior Therapy (AEBT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | This arm will begin treatment immediately after completing the initial intake assessment. Receives: 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. Receives: Behavioral: Acceptance and Commitment Therapy Enhanced Behavior Therapy (AEBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
The AFQ-Y measures psychological acceptance, cognitive fusion, and similar processes related to Acceptance and Commitment Therapy model. It serves as a potential predictor of negative outcomes.This is an 8-item Likert-type scale, with values ranging from 0= "Not at all True" to 4= "Very True". Scores from each item are summed and divided by the total number of items completed, then this average score is multiplied by 8. Higher scores indicate greater levels of distress or impairment.
Measured: 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)
The YOQ covers a variety of situations, moods, and behaviors which are common to adolescents and these may or may not apply to each participant. It provides an assessment for tracking adolescent behavior by both the adolescent and parent and gives an understanding of the effectiveness of therapy. This is a 35-item Likert-type scale with items 1-30 ranging from 0 = "Never or Almost Never" to 4 = "Always or almost always", while items 31-35 range from 0 = "Haven't met therapist yet" to 5 = "Strongly agree". The first 30 items indicate total distress in a clients' life. Scores greater than or equal to 46 indicate clinically significant distress or impairment.
Measured: 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)
The 6-PAQ provides a measure of psychological flexibility for parents/legal guardians in their interactions with their children and parenting behaviors. This is an 18-item Likert-type scale with responses ranging from 1 = "Strongly disagree/never" to 4 = "Strongly agree/almost always". Items 1, 2, 5, 7, 10, 15, and 18 are reverse scored. Lower scores represent greater levels of parental psychological flexibility, while higher scores indicate greater levels of parental psychological inflexibility.
Measured: Changes in scores from baseline, 10-week post-treatment, and 3-, 6-, and 12-month follow-ups will be assessed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start6 Aug 2018
- Primary completion5 Aug 2020 (estimated)
- Study completion5 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrichotillomaniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Utah State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Twohig, Ph.D., Utah State University
- Investigators
- Michael P Twohig, PhD, Principal investigator, Utah State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725163
- Sponsor's protocol ID
- 9153
- Status last verified
- Oct 2018
- First submitted
- 15 Oct 2018
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Once the study is complete it is possible that we may share deidentified data from participant survey scores, the protocol used, and the consent form used for the study.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telepsychotherapy for the Treatment of Adolescents With Trichotillomania
- ClinicalTrials.gov ID
- NCT03725163
- Acronym / sponsor ID
- 9153
- Conditions
- Trichotillomania
- Keywords
- Trichotillomania, Adolescents, Telepsychotherapy, AEBT, ACT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Utah State UniversityUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 5 Aug 2020 (estimated)
- Study completion
- 5 Aug 2020 (estimated)
- First posted
- 30 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Acceptance and Commitment Therapy Enhanced Behavior Therapy (AEBT)This arm will begin treatment immediately after completing the initial intake assessment. |
| Waitlist Control | Other | Behavioral: Acceptance and Commitment Therapy Enhanced Behavior Therapy (AEBT)Participants assigned to the waitlist control condition will begin a 12-week waiting period after completing the initial intake assessment before starting treatment. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Meet DSM-5 criteria for trichotillomania.
- Seeking treatment primarily for trichotillomania-related concerns.
- 12-17 years old.
- Reside in Utah.
- Speak fluent English.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Treatment, Waitlist Control |
Primary outcome
Trichotillomania Scale for Children-Chile and Parent Versions (TSC-C & TSC-p)
Time frame: 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)
Time frame: 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)
Time frame: 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.
3 secondary outcomes
Acceptance and Fusion Questionnaire for Youth (AFQ-Y8)
Time frame: 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)
Time frame: 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)
Time frame: Changes in scores from baseline, 10-week post-treatment, and 3-, 6-, and 12-month follow-ups will be assessed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Individual participant dataSharing planned: Undecided. Once the study is complete it is possible that we may share deidentified data from participant survey scores, the protocol used, and the consent form used for the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael P Twohig, PhD principal investigator
Utah State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy Enhanced Behavior Therapy (AEBT) in people with Trichotillomania, run by Utah State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeremiah E Fruge, BA (435-797-8303, jeremiah.fruge@aggiemail.usu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trichotillomania Scale for Children-Chile and Parent Versions (TSC-C & TSC-p) (time frame: Changes in scores from baseline, 10-week post-treatment, and 3-, 6-, and 12-month follow-ups will be assessed.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2018.