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Cognitive Training in Patients With Trichotillomania (Hair-pulling Disorder) (CTTTM)

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ClinicalTrials.gov Identifier: NCT02794753
Recruitment Status : Unknown
Verified June 2018 by Derine Sandenbergh, University of Stellenbosch.
Recruitment status was:  Recruiting
First Posted : June 9, 2016
Last Update Posted : June 13, 2018
Sponsor:
Collaborators:
National Research Foundation, Singapore
Medical Research Council, South Africa
Stikland Psychiatric Hospital
Information provided by (Responsible Party):
Derine Sandenbergh, University of Stellenbosch

Brief Summary:

The principal aim of this study is to establish the impact of Cognitive Training in patients with primary Hair-pulling Disorder. Half of the participants will be training with the true training intervention and the other half with the active control intervention.

Study findings will also provide information on whether an internet based CT intervention, done at patients' homes, is feasible as a mode of treatment for HPD patients in SA.


Condition or disease Intervention/treatment Phase
Trichotillomania Behavioral: Working memory training Behavioral: Game Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cognitive Training in Patients With Trichotillomania (Hair-pulling Disorder)
Actual Study Start Date : February 2016
Actual Primary Completion Date : April 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: True intervention
Working memory training on computer 5 weeks 25 sessions (5 sessions per week) 50 minutes per session
Behavioral: Working memory training
Active Comparator: Active control
Similar time spent playing on computer 5 weeks 25 sessions (5 sessions per week) 50 minutes per session
Behavioral: Game



Primary Outcome Measures :
  1. Change in Hair-pulling symptoms from baseline to immediately after 5 weeks of cognitive training / placebo, measured using the Massachusetts General Hospital - Hair-pulling Scale (MGH-HPS). [ Time Frame: Pre-intervention (prior to starting the training / placebo) to post-intervention (immediately after the 5 weeks training). ]
  2. Change in Hair-pulling symptoms from immediately after 5 weeks of cognitive training / placebo to 3 months after completion of cognitive training / placebo, measured using the Massachusetts General Hospital - Hair-pulling Scale (MGH-HPS). [ Time Frame: Post-intervention (immediately after the 5 weeks training) to 3 months Post-intervention (3 months after the training / placebo has been completed) ]

Secondary Outcome Measures :
  1. Change in Emotional regulation from baseline to immediately after 5 weeks of cognitive training / placebo, measured using the Affective Regulation Scale (ARS) and the Difficulty in Emotional Regulation Scale (DERS). [ Time Frame: Pre-intervention (prior to starting the training / placebo) to post-intervention (immediately after the 5 weeks training). ]
  2. Change in Emotional regulation from immediately after 5 weeks of cognitive training / placebo to 3 months after completion thereof, measured using the Affective Regulation Scale (ARS) and the Difficulty in Emotional Regulation Scale (DERS) [ Time Frame: Post-intervention (immediately after the 5 weeks training) to 3 months Post-intervention (3 months after the training / placebo has been completed). ]
  3. Change in ability for Impulse control baseline to immediately after 5 weeks of cognitive training / placebo, measured using the Barratt Impulsiveness Scale (BIS-11) and Stroop Color and Word Test - Adult Version (SCWT-A). [ Time Frame: Pre-intervention (prior to starting the training / placebo) to post-intervention (immediately after the 5 weeks training). ]
  4. Change in ability for Impulse control from immediately after 5 weeks of cognitive training / placebo to 3 months after completion thereof, measured using the Barratt Impulsiveness Scale (BIS-11) and Stroop Color and Word Test - Adult Version (SCWT-A) [ Time Frame: Post-intervention (immediately after the 5 weeks training) to 3 months Post-intervention (3 months after the training / placebo has been completed ]
  5. Change in Working memory, from baseline to immediately after 5 weeks of cognitive training / placebo, measured by Letter Number Sequencing (LNS) and Digit Span (DS) - both subtests from the Wechsler Adult Intelligence Scale 3rd edition (WAIS-III). [ Time Frame: Pre-intervention (prior to starting the training / placebo) to post-intervention (immediately after the 5 weeks training). ]
  6. Change in Working memory from immediately after 5 weeks of cognitive training / placebo to 3 months after completion thereof, measured using the Letter Number Sequencing (LNS) and Digit Span (DS) - subtests from the WAIS-III. [ Time Frame: Post-intervention (immediately after the 5 weeks training) to 3 months Post-intervention (3 months after the training / placebo has been completed). ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 year or older
  • Diagnosis of HPD
  • Proficient in English
  • MADRS score < 20

Exclusion Criteria:

  • Younger than 18 years.
  • Doesn't have HPD.
  • Has a serious medical condition or a previous head injury (this may impact on findings).
  • Diagnosis of depression, obsessive-compulsive disorder, substance use disorder or any other significant mental disorder (other than HPD).
  • Cannot understand or speak English (many of the tests used in the project, as well as the chosen intervention, is only available in English).
  • Have received cognitive training before (previous 'brain training' games on cell phone and/or computer allowed).
  • Do not have access to a laptop or desktop computer with reliable internet connection at home.
  • On a psychotropic medication for less than 6 weeks before starting the trial. However, will remain eligible if receiving treatment at time of screening, provided the following restrictions are met: You are only receiving a single psychotropic medication & the medication being treated with, have been taken at a steady dose, for at least 8 weeks and effect stabilizing according to psychiatrist.
  • You are not undergoing therapy. However you will remain eligible if you are receiving treatment from a psychologist or other mental health clinician at time of screening and continue to do so for the duration of the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794753


Contacts
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Contact: Derine Sandenbergh, MSc +27219404449 Derine.Sandenbergh@westerncape.gov.za
Contact: Christine Lochner, PhD +27219389179 cl2@sun.ac.za

Locations
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South Africa
Stellenbosch University Recruiting
Cape Town, Western Cape, South Africa, 7505
Contact: Derine Sandenbergh, MSc    +27219404449    Derine.Sandenbergh@westerncape.gov.za   
Contact: Christine Lochner, PhD    +27219389179    cl2@sun.ac.za   
Sponsors and Collaborators
University of Stellenbosch
National Research Foundation, Singapore
Medical Research Council, South Africa
Stikland Psychiatric Hospital
Investigators
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Principal Investigator: Derine Sandenbergh, MSc Senior clinical psychologist / Lecturer
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Responsible Party: Derine Sandenbergh, Mrs Derine Sandenbergh, University of Stellenbosch
ClinicalTrials.gov Identifier: NCT02794753    
Other Study ID Numbers: UStellenbosch
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Findings will be made available in dissertation, as well as published in articles.
Keywords provided by Derine Sandenbergh, University of Stellenbosch:
Trichotillomania
Hair-pulling Disorder
Cognitive Training
Neuroplasticity
Working Memory
Additional relevant MeSH terms:
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Trichotillomania
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders