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

NCT02794753 | Unknown DMC

• 1 other identifier: UStellenbosch
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Trichotillomania

Keywords

Trichotillomania; Hair-pulling Disorder; Cognitive Training; Neuroplasticity; Working Memory

Outcome Measures

Primary Outcomes (2)

• 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).

  Pre-intervention (prior to starting the training / placebo) to post-intervention (immediately after the 5 weeks training).

• 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).

  Post-intervention (immediately after the 5 weeks training) to 3 months Post-intervention (3 months after the training / placebo has been completed)

Secondary Outcomes (6)

• 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).

  Pre-intervention (prior to starting the training / placebo) to post-intervention (immediately after the 5 weeks training).

• 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)

  Post-intervention (immediately after the 5 weeks training) to 3 months Post-intervention (3 months after the training / placebo has been completed).

• 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).

  Pre-intervention (prior to starting the training / placebo) to post-intervention (immediately after the 5 weeks training).

• 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)

  Post-intervention (immediately after the 5 weeks training) to 3 months Post-intervention (3 months after the training / placebo has been completed

• 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).

  Pre-intervention (prior to starting the training / placebo) to post-intervention (immediately after the 5 weeks training).

Study Arms (2)

True intervention

EXPERIMENTAL

Working memory training on computer 5 weeks 25 sessions (5 sessions per week) 50 minutes per session

Behavioral: Working memory training

Active control

ACTIVE COMPARATOR

Similar time spent playing on computer 5 weeks 25 sessions (5 sessions per week) 50 minutes per session

Behavioral: Game

Interventions

Working memory training BEHAVIORAL

True intervention

Game BEHAVIORAL

Active control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Stellenbosch: lead
• National Research Foundation, Singapore: collaborator
• Medical Research Council, South Africa: collaborator
• Stikland Psychiatric Hospital: collaborator

Study Sites (1)

Stellenbosch University

Cape Town, Western Cape, 7505, South Africa

RECRUITING

MeSH Terms

Conditions

Trichotillomania

Condition Hierarchy (Ancestors)

Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders

Study Officials

• Derine Sandenbergh, MSc

  Senior clinical psychologist / Lecturer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Derine Sandenbergh, MSc

CONTACT

+27219404449; Derine.Sandenbergh@westerncape.gov.za

Christine Lochner, PhD

CONTACT

+27219389179; cl2@sun.ac.za

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mrs Derine Sandenbergh

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 9, 2016
• Study Start: February 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 13, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

ZA (1)