TrichotillomaniaNCT00043563
Cognitive Behavioral Treatment of Pediatric Trichotillomania
A study testing Cognitive-Behavior Therapy in people with Trichotillomania, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study will compare the effectiveness of cognitive-behavior therapy (CBT) to a minimal attention control (AC) condition for treatment of pediatric trichotillomania (TTM). Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Trichotillomania
- What is being tested?
- Cognitive-Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2001to Oct 2004
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Primary diagnosis of Trichotillomania
- Minimum symptom duration of 6 months
- Presence of a stable parent or guardian
Who cannot join
- Other primary psychiatric diagnosis
- Bipolar illness, pervasive developmental disorder, thought disorder, current major depression, ADD/ADHD
- Concurrent psychotherapy
- Currently receiving psychotropic medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for the Treatment and Study of Anxiety
Philadelphia, Pennsylvania, 19104
About this study
This study will compare the effectiveness of cognitive-behavior therapy (CBT) to a minimal attention control (AC) condition for treatment of pediatric trichotillomania (TTM).
Read the detailed description
TTM is a persistent impulse control disorder in which the individual acts on urges to pull out his or her own hair. Onset typically occurs by adolescence, and TTM is often associated with significant functional impairment and distress. CBT is a type of psychotherapy designed to change problematic behaviors and thinking. It includes self-monitoring of hair-pulling urges and homework assignments to practice the use of cognitive and behavioral strategies.
Participants are assigned randomly to receive either CBT or AC for 8 weeks. Participants assigned to CBT receive weekly 1-hour sessions of CBT for 8 weeks; participants assigned to AC receive 6 telephone contacts and 2 in-person sessions for 8 weeks. After 8 weeks, CBT participants who respond to treatment enter Phase II, which lasts an additional 8 weeks and includes 4 in-person maintenance sessions. AC participants who are still symptomatic after 8 weeks are offered CBT.
- Conditions
- Trichotillomania
- Being tested
- Cognitive-Behavior Therapy
- Keywords
- Cognitive-behavior Therapy, Minimal Attention Control
- Medical subject headings
- Trichotillomania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavior TherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
National Institute of Mental Health (NIMH) Trichotillomania Severity Scale
Semi-structured interview about hair-pulling and related symptoms
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2002 (estimated)
- Study startJan 2001
- Primary completionOct 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TrichotillomaniaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00043563
- Sponsor's protocol ID
- R21MH061457
- Other IDs
- R21MH061457, DSIR CT-S
- Status last verified
- Dec 2015
- First submitted
- 9 Aug 2002
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Franklin ME, Edson AL, Ledley DA, Cahill SP. Behavior therapy for pediatric trichotillomania: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2011 Aug;50(8):763-71. doi: 10.1016/j.jaac.2011.05.009. Epub 2011 Jul 1.
PubMed 21784296Franklin ME, Edson AL, Freeman JB. Behavior therapy for pediatric trichotillomania: Exploring the effects of age on treatment outcome. Child Adolesc Psychiatry Ment Health. 2010 Jun 28;4:18. doi: 10.1186/1753-2000-4-18.
PubMed 20584275
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Treatment of Pediatric Trichotillomania
- ClinicalTrials.gov ID
- NCT00043563
- Acronym / sponsor ID
- R21MH061457
- Conditions
- Trichotillomania
- Keywords
- Cognitive-behavior Therapy, Minimal Attention Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2001
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 12 Aug 2002 (estimated)
- 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.
This study will compare the effectiveness of cognitive-behavior therapy (CBT) to a minimal attention control (AC) condition for treatment of pediatric trichotillomania (TTM).
Detailed description
TTM is a persistent impulse control disorder in which the individual acts on urges to pull out his or her own hair. Onset typically occurs by adolescence, and TTM is often associated with significant functional impairment and distress. CBT is a type of psychotherapy designed to change problematic behaviors and thinking. It includes self-monitoring of hair-pulling urges and homework assignments to practice the use of cognitive and behavioral strategies.
Participants are assigned randomly to receive either CBT or AC for 8 weeks. Participants assigned to CBT receive weekly 1-hour sessions of CBT for 8 weeks; participants assigned to AC receive 6 telephone contacts and 2 in-person sessions for 8 weeks. After 8 weeks, CBT participants who respond to treatment enter Phase II, which lasts an additional 8 weeks and includes 4 in-person maintenance sessions. AC participants who are still symptomatic after 8 weeks are offered CBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Primary diagnosis of Trichotillomania
- Minimum symptom duration of 6 months
- Presence of a stable parent or guardian
Key exclusion criteria (4 listed)
- Other primary psychiatric diagnosis
- Bipolar illness, pervasive developmental disorder, thought disorder, current major depression, ADD/ADHD
- Concurrent psychotherapy
- Currently receiving psychotropic medications
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 |
|---|---|---|
| Cognitive-Behavior Therapy | Behavioural | – |
Primary outcome
National Institute of Mental Health (NIMH) Trichotillomania Severity Scale
Time frame: 1 week
Semi-structured interview about hair-pulling and related symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
- Derived from this study: PubMed 21784296Franklin ME, Edson AL, Ledley DA, Cahill SP. Behavior therapy for pediatric trichotillomania: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2011 Aug;50(8):763-71. doi: 10.1016/j.jaac.2011.05.009. Epub 2011 Jul 1.
- Derived from this study: PubMed 20584275Franklin ME, Edson AL, Freeman JB. Behavior therapy for pediatric trichotillomania: Exploring the effects of age on treatment outcome. Child Adolesc Psychiatry Ment Health. 2010 Jun 28;4:18. doi: 10.1186/1753-2000-4-18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavior Therapy in people with Trichotillomania, run by University of Pennsylvania 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 3 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: finished, as of the sponsor's last update on 16 Dec 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Institute of Mental Health (NIMH) Trichotillomania Severity Scale (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00043563, which also lists 2 linked publications.
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 16 Dec 2015.