Neural Mechanisms of Response Inhibition Training for OCRD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Wisconsin, Milwaukee
About this trial
The impaired ability to suppress an inappropriate but pre-potent response (response inhibition; RI) characterizes several debilitating clinical problems, including obsessive-compulsive and related disorders (OCRD) such as obsessive-compulsive disorder, trichotillomania, and skin picking disorder. There is a critical need to develop an effective and durable treatment for OCRDs with demonstrable evidence for improving impaired RI. The purpose of our project is to examine the impact of a novel computerized intervention, response inhibition training (RIT), on neural indices of RI, and examine the mechanistic link between engagement of the neural RI targets and change in OCRD symptoms. To this end, this project will conduct a randomized clinical trial for individuals with OCD, trichotillomania, and/or skin picking disorders. Participants will be randomly assigned to 8 to 16 sessions of computerized RIT or a computerized placebo training. Various clinical, behavioral, and brain-imaging data will be acquired to evaluate the training effects at baseline, post-training, and 1-month follow-up periods.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age between 18 and 60
moderate level of OCRD symptoms (Yale-Brown Obsessive Compulsive Scale total ≥ 16, Massachusetts General Hospital-Hair pulling Scale total ≥ 12, or Skin Picking Scale-Revised total ≥ 7)
a primary diagnosis of OCRD (i.e., OCD, TTM, or SPD)
estimated IQ > 80
Disqualifiers
Current substance use disorder
Severe ADHD
Lifetime diagnosis of psychotic disorder, bipolar disorder, or schizophrenia
Current psychotherapy
Trial design
Design model
Parallel
Treatments tested in this trial
Computerized cognitive training
BehavioralThis intervention offers 45-minute computerized training sessions to each participant. This intervention aims to improve the individual's RI capabilities. All participants will receive 8 to 16 sessions after being randomized to this condition.
Computerized placebo training
BehavioralThis intervention offers 45-minute computerized placebo cognitive training sessions to each participant. This intervention aims to exert no focused training on RI capabilities. All participants will receive 8 to 16 sessions after being randomized to this condition.
Treatment groups
118 Participants
are divided into 2 treatment groupsGroup A: Response Inhibition Training (RIT)Experimental treatment 1 intervention
Group B: Placebo Training (PLT)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in obsessive-compulsive disorder symptom severity over time
Depending on participant's primary diagnostic condition, Yale-Brown Obsessive Compulsive Scale (YBOCS) will be used as the primary outcome measure for assessing the change in OCD symptoms over time. The total score ranges between 0 and 40 with higher scores indicating worse outcomes (= more severe symptoms).
Time frame
Week 0, Week 4, Week 8 ~ 122
Change in compulsive hair pulling symptom severity over time
Depending on participant's primary diagnostic condition, National Institute of Mental Health - Trichotillomania Symptom Severity Scale (NIMH-TSS) will be used as the primary outcome measure for assessing the change in hair pulling symptoms over time. The total score ranges between 0 and 25 with higher scores indicating worse outcomes (= more severe symptoms).
Time frame
Week 0, Week 4, Week 8 ~ 123
Change in compulsive skin picking symptom severity over time
Depending on participant's primary diagnostic condition, Yale-Brown Obsessive Compulsive Scale modified for Neurotic Excoriation (NE-YBOCS) will be used as the primary outcome measure for assessing the change in skin picking symptoms over time. The total score ranges between 0 and 40 with higher scores indicating worse outcomes (= more severe symptoms).
Time frame
Week 0, Week 4, Week 8 ~ 124
Change in activation in the right inferior frontal cortex (rIFC)
Change in the level of blood-oxygen-level-dependent (BOLD) signal activation in the right inferior frontal cortex (rIFC) will be assessed using the stop-signal task (SST) that will be administered while the participant undergoes a functional magnetic resonance imaging procedure.
Time frame
Week 0, Week 4Secondary outcomes
1
Change in the Clinical Global Impression Scale
The Clinical Global Impression Scale (CGI-I) is a clinician-administered rating scale on the overall improvement of the participant's condition throughout treatment. The rating score ranges between 1 and 8 with higher scores indicating worse outcomes (= more severe symptoms).
Time frame
Week 0, Week 4, Week 8 ~ 12Sponsors and contacts
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Source ClinicalTrials.gov