TrichotillomaniaPhase 2NCT01968343
Trichotillomania: Group Cognitive-Behavioral Therapy
A Phase 2 study testing Cognitive-behavioral therapy. and Supportive therapy. in people with Trichotillomania, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Objective: Trichotillomania is a psychiatric condition characterized by chronic pulling and plucking of one's own hair. Cognitive behavioral therapy shows promise as a treatment. However, there have been no randomized, controlled studies of the efficacy of group cognitive-behavioral therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trichotillomania
- What is being tested?
- Cognitive-behavioral therapy. and Supportive therapy.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2008to Dec 2010
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having been diagnosed with trichotillomania according to Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria; being at least 18 years of age; and having had four or more years of schooling.
Who cannot join
- Patients that having been diagnosed with trichotillomania according to DSM-IV criteria; having less of 18 years of age; and having less of four years of schooling.
- Patients with a history of suicidal ideation,
- Patients with any clinical pathology requiring emergency treatment at admission,
- Patients with mental retardation or any other central nervous system disorder that severely impairs cognitive function,
- those with a psychotic disorder,
- those currently being treated with psychotropic drugs,
- those with any DSM-IV axis II diagnosis,
- those who scored ≤ 2 on the MGH-HPS in an initial screening.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Psiquiatria da Universidade de São Paulo
São Paulo, São Paulo, 05403-010
About this study
Official title: Group Treatment for Trichotillomania: Cognitive-Behavioral Therapy Versus Supportive Therapy
Objective: Trichotillomania is a psychiatric condition characterized by chronic pulling and plucking of one's own hair. Cognitive behavioral therapy shows promise as a treatment. However, there have been no randomized, controlled studies of the efficacy of group cognitive-behavioral therapy. Methods: We evaluated 44 subjects, whom met the criteria for a diagnosis of trichotillomania. Subjects were randomized to receive 22 sessions of either group cognitive-behavioral therapy or group supportive therapy (control).
- Conditions
- Trichotillomania
- Being tested
- Cognitive-behavioral therapy., Supportive therapy.
- Medical subject headings
- Trichotillomania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral therapy.Behavioural
Subjects receive 22 sessions of cognitive-behavioral therapy.
Supportive therapy.Other
Subjects receive 22 sessions of supportive therapy.
| Study group | Role | What they receive |
|---|---|---|
| Group cognitive-behavioral therapy | Experimental | 22 subjects, all of whom met the criteria for a diagnosis of trichotillomania established in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Subjects receive 22 sessions of group cognitive-behavioral therapy. Receives: Behavioral: Cognitive-behavioral therapy. |
| Group supportive therapy (control) | Active comparator | 22 subjects, all of whom met the criteria for a diagnosis of trichotillomania established in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Subjects receive 22 sessions of group supportive therapy (control). Receives: Other: Supportive therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Massachusetts General Hospital (MGH) Hairpulling Scale (HPS)
The MGH-HPS comprises seven self-report items that are scored on a Likert scale (0-4 points).22 Higher MGH-HPS scores correspond to greater severity of trichotillomania symptoms. Reference: Psychotherapy and Psychosomatic Journal 1995;64:141-5
Measured: 22 weeks
Secondary outcomes (1)
Beck Depression Inventory (BDI)
The BDI consists of 21 items, scored from 0 to 3, higher scores corresponding to greater severity of depression. It is a self-report measure of depression that is widely used in research and in clinical practice. Reference: Archives of General Psychiatry 1961;4:53-63.
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startJan 2008
- Primary completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hermano Tavares, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968343
- Sponsor's protocol ID
- CaPPesq 0013/08
- Status last verified
- Oct 2013
- First submitted
- 20 Sep 2013
- Last updated
- 19 Aug 2015
- Results posted
- No
Publications
Toledo EL, De Togni Muniz E, Brito AM, de Abreu CN, Tavares H. Group treatment for trichotillomania: cognitive-behavioral therapy versus supportive therapy. J Clin Psychiatry. 2015 Apr;76(4):447-55. doi: 10.4088/JCP.13m08964.
PubMed 25271779
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Treatment for Trichotillomania: Cognitive-Behavioral Therapy Versus Supportive Therapy
- ClinicalTrials.gov ID
- NCT01968343
- Acronym / sponsor ID
- CaPPesq 0013/08
- Conditions
- Trichotillomania
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2010 (actual)
- First posted
- 24 Oct 2013 (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.
Objective: Trichotillomania is a psychiatric condition characterized by chronic pulling and plucking of one's own hair. Cognitive behavioral therapy shows promise as a treatment. However, there have been no randomized, controlled studies of the efficacy of group cognitive-behavioral therapy. Methods: We evaluated 44 subjects, whom met the criteria for a diagnosis of trichotillomania. Subjects were randomized to receive 22 sessions of either group cognitive-behavioral therapy or group supportive therapy (control).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group cognitive-behavioral therapy | Experimental | Behavioral: Cognitive-behavioral therapy.22 subjects, all of whom met the criteria for a diagnosis of trichotillomania established in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Subjects receive 22 sessions of group cognitive-behavioral therapy. |
| Group supportive therapy (control) | Active comparator | Other: Supportive therapy.22 subjects, all of whom met the criteria for a diagnosis of trichotillomania established in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Subjects receive 22 sessions of group supportive therapy (control). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients having been diagnosed with trichotillomania according to Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria; being at least 18 years of age; and having had four or more years of schooling.
Key exclusion criteria (8 listed)
- Patients that having been diagnosed with trichotillomania according to DSM-IV criteria; having less of 18 years of age; and having less of four years of schooling.
- Patients with a history of suicidal ideation,
- Patients with any clinical pathology requiring emergency treatment at admission,
- Patients with mental retardation or any other central nervous system disorder that severely impairs cognitive function,
- those with a psychotic disorder,
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-behavioral therapy.Subjects receive 22 sessions of cognitive-behavioral therapy. | Behavioural | Group cognitive-behavioral therapy |
| Supportive therapy.Subjects receive 22 sessions of supportive therapy. | Other | Group supportive therapy (control) |
Primary outcome
Massachusetts General Hospital (MGH) Hairpulling Scale (HPS)
Time frame: 22 weeks
The MGH-HPS comprises seven self-report items that are scored on a Likert scale (0-4 points).22 Higher MGH-HPS scores correspond to greater severity of trichotillomania symptoms. Reference: Psychotherapy and Psychosomatic Journal 1995;64:141-5
1 secondary outcome
Beck Depression Inventory (BDI)
Time frame: 22 weeks
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 19 Aug 2015.
- Derived from this study: PubMed 25271779Toledo EL, De Togni Muniz E, Brito AM, de Abreu CN, Tavares H. Group treatment for trichotillomania: cognitive-behavioral therapy versus supportive therapy. J Clin Psychiatry. 2015 Apr;76(4):447-55. doi: 10.4088/JCP.13m08964.
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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 Phase 2 study testing Cognitive-behavioral therapy. and Supportive therapy. in people with Trichotillomania, run by University of Sao Paulo at 1 site in Brazil.
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 1 inclusion and 8 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 19 Aug 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 Brazil. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Massachusetts General Hospital (MGH) Hairpulling Scale (HPS) (time frame: 22 weeks). 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 NCT01968343, which also lists 1 linked publication.
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 19 Aug 2015.