Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201608001653127 Date of Approval: 27/05/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Cognitive training in patients with Trichotillomania (Hair-pulling disorder)
Official scientific title Cognitive training in patients with Trichotillomania (Hair-pulling disorder)
Brief summary describing the background and objectives of the trial Hair-pulling disorder (HPD) has not received much attention in comparison to other psychiatric illnesses. Considering South African research, only a limited number of studies have focused on HPD with minimal focus on treatment interventions. Several treatments with regards to pharmacotherapy and psychotherapy have been developed and investigated. Evidence suggests limited efficacy of these treatments, thus there is a need for an intervention that shows better efficacy in symptom reduction with longer maintenance of treatment gains, whilst also being cost-effective and easily accessible. Studies have indicated that patients with HPD experience difficulty in working memory (WM), impulse control (IC) and emotion regulation (ER). The principal aim of this project is to establish the impact of CT in patients with primary HPD. 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. The proposed research will focus on the following objectives: To determine the effect of CT (25 sessions over 5 weeks) on WM, ER, IC and hair-pulling severity (HPS), in patients with HPD. To determine whether the effect of the true CT program on WM, ER, IC and HPS differed from that of the active control program. To determine whether effects are maintained at 3 months post-intervention. To qualitatively explore participants¿ subjective experience of the intervention process and responses to CT (in terms of WM, ER, IC and HPS).It is hypothesised that after 5 weeks of CT, the treatment HPD group will show significant improvement in WM, ER, IC and significant reduction in HPS. The effect of the true CT program on WM, ER, IC and HPS will be significantly different from the active control group. During a 3-month follow-up evaluation, the HPD intervention group will have maintained reduction in symptoms after the treatment, compared to the active control HPD group.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CTTTM
Disease(s) or condition(s) being studied trichotillomania, hair-pulling disorder
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/02/2016
Actual trial start date 08/02/2016
Anticipated date of last follow up 31/12/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
Stellenbosch University HREC S15/10/216 ClinicalTrials.gov NCT02794753
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using randomisation table provided by statistician Allocation determined by list provided by statistician situated off site. Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Cogmed Working Memory Training 25 session, 5 sessions per week 50 minutes per session Working Memory Training 20
Control Group Jigsaw Puzzles 25 session, 5 sessions per week 50 minutes per session Build jigsaw puzzles online 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Diagnosis of HPD Access to laptop/computer with reliable internet access 18 years or older Younger than 18 years. Does not have HPD. Has a serious medical condition or a previous head injury (this may impact on findings). A 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: * Are only receiving a single psychotropic medication * The medication you are being treated with, have been taken at a steady dose, for at least 8 weeks and effect stabilizing according to psychiatrist. 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. 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/02/2016 Health Research Ethic Committee Stellenbosch University
Ethics Committee Address
Street address City Postal code Country
Francie Van Zijl Dr, Tygerberg Hospital Cape Town 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Hair-pulling Symptoms Pre-intervention Immediate post-intervention 3 months post-intervention
Secondary Outcome Emotional Regulation Pre-intervention Immediate post-intervention 3 months post-intervention
Secondary Outcome Working Memory Pre-intervention Immediate post-intervention 3 months post-intervention
Secondary Outcome Impulse Control Pre-intervention Immediate post-intervention 3 months post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Psychiatry Tygerberg Campus, Franci van Zijl Cape Town 7505 South Africa
Department of Psychology Stikland Hospital, De la Haye Avenue Bellville 7530 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Research Foundation 1 Meiring Naude Rd Pretoria 0081 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Research Foundation 1 Meiring Naude Rd Pretoria 0081 South Africa Funding Agency
Secondary Sponsor Stikland Psychiatric Hospital De la Haye Avenue Bellville 7530 South Africa Hospital
Primary Sponsor University of Stellenbosch Francie Van Zijl Dr, Tygerberg Hospital Cape Town 7505 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Anxiety and Stress Disorders Research Unit Francie Van Zijl Dr, Tygerberg Hospital Cape Town 7505 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Derine Sandenbergh Derine.Sandenbergh@westerncape.gov.za +27219404449 Psychology Department, Stikland Psychiatric Hospital, De la Haye Avenue
City Postal code Country Position/Affiliation
Bellville 7530 South Africa Principle investigator
Role Name Email Phone Street address
Public Enquiries Derine Sandenbergh Derine.Sandenbergh@westerncape.gov.za +27219404449 Psychology Department, Stikland Psychiatric Hospital, De la Haye Avenue
City Postal code Country Position/Affiliation
Bellville 7530 South Africa Principle investigator
Role Name Email Phone Street address
Scientific Enquiries Derine Sandenbergh Derine.Sandenbergh@westerncape.gov.za +27219404449 Psychology Department, Stikland Psychiatric Hospital, De la Haye Avenue
City Postal code Country Position/Affiliation
Bellville 7530 South Africa Principle investigator
REPORTING
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