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Recruiting NCT06828471

Social Cognition Training in Individuals With Huntington's Disease

No phase Interventional Huntington's Disease (HD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Social Cognition Training.
Who it may be relevant to
Registry conditions: Huntington's Disease (HD). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Social Cognition Training in Individuals With Huntington's Disease: A Feasibility Study

Overview

Individuals with Huntington's Disease have impaired social cognition, which is the domain of cognition that allows individuals to understand others' perspectives so that they can navigate interpersonal actions successfully (e.g., understanding someone may be sad based of their facial emotion or tone of voice and then responding in a sympathetic manner). Impaired social cognition is associated with impaired social functioning, poor psychological wellbeing and increased caregiver burden, which is known to be significant among those who care for individuals with Huntington's Disease. Computerized social cognition training has been shown to improve social cognition in individuals with schizophrenia, who, like individuals with Huntington's disease, have cognitive impairments. The investigators propose a pilot study of computerized social cognition training in individuals with Huntington's disease. This will be a feasibility study that aims to show that social cognition training in HD can be studied in preparation for a larger randomized controlled trial. The investigators hypothesize that social cognition training can improve social cognition, social functioning, and quality of life in individuals with Huntington's Disease and decrease caregiver burden among those who care for individuals with Huntington's Disease.

Interventions

  • Behavioral Social Cognition Training
    Neuroplasticity-based social cognition training that targets a range of social cognition skills, including visual and vocal affect perception, social cue perception, theory of mind, self-referential style, and empathy

Primary outcome measures

  • Proportion of participants willing to consider study out of those who have been approached [Time frame: 32 months]
  • Number of participants who adhered and completed the study [Time frame: 32 months]
  • Ease of program on a scale of 1 to 5 with 5 being "very easy." [Time frame: 32 months]
  • Participant satisfaction with the program [Time frame: 32 months]
Secondary outcome measures (6)
  • Change in accuracy on a facial emotion recognition task [Time frame: 6-12 weeks]
  • Change in accuracy on an empathic accuracy task [Time frame: 6-12 weeks]
  • Change in score on the Quality of Life in Neurological Disorders Ability to Participate in Social Roles and Activities (scores range from 45 to 225; higher score indicates better outcome) [Time frame: 6-12 weeks]
  • Change in score on the Quality of Life in Neurological Disorders Satisfaction with Social Roles and Activities Questionnaire (scores range from 45 to 225; higher score indicates better outcome) [Time frame: 6-12 weeks]
  • Change in score on the Quality of Life in Neurological Disorders Positive Affect and Wellbeing Questionnaire (scores range from 23 to 115; higher score indicates better outcome) [Time frame: 6-12 weeks]
  • Change in score on the Caregiver Burden Inventory (scores range from 0-96; lower score indicates better outcome) [Time frame: 6-12 weeks]

Eligibility criteria

Inclusion Criteria for Individual with Huntington's Disease

  • Diagnosed with Huntington's Disease based on genetic testing
  • Must be between 18 and 65 years of age
  • Native English speaker who is literate in English
  • Stable psychotropic medication regimen for 4 weeks
  • Must have a score of "somewhat easily" on all items in the CPQ-12
  • MOCA >18
  • Completed 12 years of schooling
  • Access to laptop or mobile device
  • Willingness to come in person 6-12 weeks after first visit

Inclusion Criteria for Caregiver of Individual with Huntington's Disease

  • Lives with patient
  • Must be between 18 and 65 years of age
  • Native English speaker who is literate in English
  • MOCA >26
  • Willingness to come in person within 6-12 weeks after first visit

Exclusion Criteria for Individual with Huntington's Disease

  • Any known neurological condition (other than Huntington's Disease).
  • History of learning and/or intellectual disabilities
  • Currently actively involved in any other interventional trial (i.e. have begun the intervention) or within 4 weeks of completing the final assessments of an interventional trial.
  • Currently regularly completing a computerized cognitive training intervention.
  • Active suicidal ideation with some intent

Exclusion Criteria for Caregiver of Individual with Huntington's Disease

  • Inability to provide informed consent
  • Active suicidal ideation with some intent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Rush University Medical Center — Chicago

Identifiers

NCT: NCT06828471 · 24112605

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗