Cognitive training game for Social Skills

Vanderbilt University, Nashville, TN

Targeting 3 different conditionsCognitive training +1 moreN/ARecruitingLed by Sohee Park, Ph.D.Research Sponsored by Vanderbilt University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Currently taking antipsychotic medication

No DSM-5 Axis 1 diagnosis of psychotic disorders in themselves or their families (e.g. schizophrenia, bipolar disorder).

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upbaseline and 5 weeks. in addition, it will also be used to assess long term outcome 2 months after the training has ended.

Awards & highlights

No Placebo-Only Group

Study Summary

This trial will compare a new VR social skills training intervention with a control condition to see if it is more effective in improving social skills in people with schizophrenia.

Eligible Conditions

Social Skills
Schizophrenia
Schizoaffective Disorder

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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You are currently taking medication for mental illness.

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You or your family members do not have a history of severe mental illnesses like schizophrenia or bipolar disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 5 weeks. in addition, it will also be used to assess long term outcome 2 months after the training has ended.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 5 weeks. in addition, it will also be used to assess long term outcome 2 months after the training has ended.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 5 weeks. in addition, it will also be used to assess long term outcome 2 months after the training has ended. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Social Attention: Social Engagement Latency (SEL)

Change in Social Brain Network Activity

Secondary outcome measures

Change in Scale for the Assessment of Negative Symptoms (SANS)

Change in Scale for the Assessment of Positive Symptoms (SAPS)

Change in Social Emotion Recognition (BLERT)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Cognitive training gameExperimental Treatment1 Intervention

If there is a significant improvement in social skills for the active treatment condition, the reason might be that the participants were exposed to social environment by coming to the lab and interacting with the research staff twice a week for 5 weeks and/or they used a computerized training tool twice a week for 5 weeks. In order to control for these potential confounds, we included a cognitive training arm. Participants will undergo a commercially available cognitive training program for ten 1-hour sessions (twice a week for 5 weeks).

Group II: VR Social Skills TrainingActive Control1 Intervention

Participants will undergo a virtual reality social skills training program for 10 sessions. Each session takes about an hour. Participants visit the lab twice a week. Therefore, the training duration is 5 weeks.

Group III: Healthy ControlsActive Control1 Intervention

Healthy controls are recruited to yield comparison data. They do not undergo training.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive training

2019

Completed Phase 3

~1350

0 / 2Eligibility criteria met

Find a site

Who is running the clinical trial?

Vanderbilt UniversityLead Sponsor

693 Previous Clinical Trials

6,134,775 Total Patients Enrolled

Sohee Park, Ph.D.Principal Investigator

Vanderbilt University

Media Library

VR social skills training Clinical Trial Eligibility Overview. Trial Name: NCT04005794 — N/A

Social Skills Research Study Groups: VR Social Skills Training, Cognitive training game, Healthy Controls

Social Skills Clinical Trial 2023: VR social skills training Highlights & Side Effects. Trial Name: NCT04005794 — N/A

VR social skills training 2023 Treatment Timeline for Medical Study. Trial Name: NCT04005794 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are enrolled in this research initiative?

"Affirmative. The clinical trial information on clinicialtrials.gov reveals that patient recruitment for this medical study has commenced since October 15th 2021 and is actively ongoing. This investigation requires 56 participants from a single site."

Answered by AI

Does this research allow those aged fifty or above to participate?

"According to the enrollment criteria for this medical trial, no one under 18 years old or over 65 years old can participate."

Answered by AI

Is there still availability for participants in this trial?

"Yes, according to clinicaltrials.gov records this trial is currently recruiting patients; the original listing was posted on October 15th 2021 and recently updated on October 29th 2021. The study aims to enrol 56 participants at a single site."

Answered by AI

What is the ultimate aim of this experimental research?

"This trial will measure its success by evaluating the Change in Social Brain Network Activity over a period of 5 weeks, as well as changes to the Scale for the Assessment of Positive Symptoms (SAPS), Social Emotion Recognition (BLERT) and Social Outcome. The latter is assessed using the Social Functioning Scale which consists of seven subscales normalised into Scaled Scores with an average value at 100."

Answered by AI

Could I potentially be eligible to join this medical research study?

"This medical study is recruiting 56 participants with social skills and age falling between 18 to 65. To be considered, prospective candidates must meet these respective criteria."

Answered by AI