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

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Brief Title

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

Official Title

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

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.
    

Detailed Description

      Introduction and conceptualization 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 involvement of the
      frontoparietal circuitry, as well as frontal cortex, amygdalo-hippocampal formation and
      putamen have been specified in HPD. WM and ER circuitry are both based in the frontoparietal
      neural circuit, and thus training of WM shows potential to also address ER difficulties. An
      intervention focusing on WM training, may promise to address difficulties in IC and ER, and
      thus be appropriate in the treatment of patients with HPD. Cognitive training (CT) is a novel
      intervention that focuses on enhancing executive functioning and more specifically WM. WM
      tasks in CT also focus on the frontoparietal network which plays a role in ER, and therefore
      when this network is activated by executive functioning tasks, ER should improve. The
      positive impact of computerized cognitive training (CCT) on neuroplasticity in these
      indicated pathways have recently been acknowledged. Psychotherapeutic support might not be
      readily available or accessible to most people in developing countries, such as South Africa.
      Indeed, locally the physical distance from mental health centres and cost of individual
      sessions with health care professionals, are challenging - preventing patients finding the
      help that they need. CT can thus be a more accessible and cost-effective alternative. Cogmed
      Working Memory Training, an internet-based CT program, will be investigated for its efficacy
      in the treatment of HPD.

      Purpose of the study: 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. The treatment HPD
      group will generally be positive about the effects of CT on HPD and their functioning at
      post-intervention and 3-month follow-up and consider CT as easy to use and affordable.

      Study design: The study design is a 5-week, 25-session intervention study with an active
      control, and 3-month follow-up evaluation. As a registered clinical psychologist, the
      principal investigator has the expertise to diagnose, do clinical interviews, and implement
      the psychometric battery pre and post intervention. Inclusion criteria is a primary diagnosis
      of HPD (DSM-5); Adults (18 years and older); Fluent in English; Access to the internet for
      the duration of their study participation. Exclusion criteria is any significant current DSM
      comorbidity; Montgomery-Asberg Depression Rating Scale (MADRS) Score > 20 to exclude patients
      with comorbid depressive syndromes; Previous exposure to cognitive training (previous 'brain
      training' games on cell phone and/or computer allowed). The criteria will be assessed during
      the screening procedure. Participants will enter the study as recruited and randomly assigned
      to the treatment or active control group. Participants entering the study will be randomized
      into the intervention or active control group, using a randomization list provided by the
      statistician. The intervention task (Cogmed QM) and the placebo (Jigsaw Puzzles) differ
      significantly. The principal investigator will not be blind to the group that the
      participants are in, whereas the participants will be blind to their group inclusion. It is
      aimed to achieve a sample size of at least 40 (20 treatment, 20 active control). This is
      comparable to group sizes in other HPD treatment studies. The research method is based in
      embedded theory design, utilizing both quantitative and qualitative components. The benefit
      of this hybrid approach is to be able to investigate and describe subject matter with
      statistical power, as well as being able to comment on the participant's experience, thus
      creating a richer and more holistic description of the research theme. The quantitative
      research consists of the pre- and post intervention assessment battery, 3-month follow-up
      evaluation and continuous information provided by the treatment intervention (Cogmed). The
      qualitative data analysis will be done on semi-structured interviews, as part of the pre- and
      post assessment battery and 3-month follow-up evaluation. Pre- and post intervention data
      collection will be done by the principal investigator by means of the assessment battery
      including both quantitative and qualitative measures. Statistical analysis will be conducted
      using mixed model repeated measures ANOVA, which is most suitable for dealing with possible
      lost to follow-up. Patients in the study will be treated as random effects (randomly selected
      from a larger population). Treatment (intervention vs placebo) and time (pre, post, 3 months)
      will be treated as fixed effects. The treatment*time interaction effect will be the primary
      effect of investigation because it tests whether the change over time is the same for the two
      groups. If the intervention has a different effect to the placebo, then this interaction
      effect should be significant. Post hoc testing will be done using Fisher Least Significant
      Difference (LSD) testing. Normality assumptions will be checked for all analyses and
      appropriately dealt with if necessary, based on the nature of the data. A 5% significance
      level will be used as guideline for significant results. The qualitative data will be
      analysed using an interpretative phenomenological approach (TerreBlanche, Durrheim, & Kelly,
      2010), utilizing a qualitative data analysis software program, Atlas.ti.

      Anticipated benefits and risks: CT has not been investigated as a treatment intervention for
      HPD and reduction of HPS cannot be guaranteed. However, HPS may reduce during the true CT
      program. Participants, who are part of the placebo group, will get the opportunity to access
      the true CT program on completion of the study. Except for the fact that they might not be in
      the treatment group for the duration of the study due to randomization, there are no known
      risks involved in participation.

      Ethical Considerations: The study procedures, risks and benefits will be communicated in lay
      terminology to all participants (verbally and in writing) in Afrikaans or English. All data
      collected will be kept strictly confidential and study results made public and published
      without compromising confidentiality. The demographics questionnaire will be removed from the
      questionnaire pack to ensure that the completed questionnaires and the demographic details
      cannot be linked. Personal identifying details such as the name and contact information will
      not be recorded on the electronic database. All participants will be allocated a unique study
      code on the electronic database. Identifiers linked to a study code will be kept in a
      separate, password protected file. Only the principal investigator will have access to this
      information. It will be clearly indicated that the participant is free to withdraw
      participation from this trial, without consequence. Participating individuals will incur no
      costs.
    


Study Type

Interventional


Primary Outcome

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).

Secondary Outcome

 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).

Condition

Trichotillomania

Intervention

Working memory training

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

40

Start Date

February 2016

Completion Date

December 2018

Primary Completion Date

April 2018

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Derine Sandenbergh, MSc, +27219404449, [email protected]

Location Countries

South Africa

Location Countries

South Africa

Administrative Informations


NCT ID

NCT02794753

Organization ID

UStellenbosch


Responsible Party

Principal Investigator

Study Sponsor

University of Stellenbosch

Collaborators

 National Research Foundation, Singapore

Study Sponsor

Derine Sandenbergh, MSc, Principal Investigator, Senior clinical psychologist / Lecturer


Verification Date

June 2018