Cognitive Control Training for Urgency in a Naturalistic Clinical Setting

NCT03527550 | Terminated Results

• 2 other identifiers: 2017P0015501F32MH115530
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to test whether computer-based cognitive exercises are helpful for reducing a specific type of impulsivity. Also, the study is testing whether these are exercises are associated with specific changes in behavior and in the brain. Participants will be psychiatric patients enrolled in a partial hospitalization program. Half of these participants will receive usual treatment, and half will complete computer-based cognitive exercises in addition to usual treatment.

Conditions

Impulsive Behavior; Mental Disorders

Keywords

impulsivity; Inhibition (Psychology); Working memory; Cognitive Remediation

Outcome Measures

Primary Outcomes (2)

• Average Score on Negative Urgency Scale at Discharge

  This scale assesses tendencies towards impulsive action in response to negative emotion. The scale ranges from 1-4, with higher scores indicating more problems with this type of impulsivity.

  Admission and at study completion (day of discharge), an average of two weeks. Scores reported below are at day of discharge.

• Average Score on the Short Positive Urgency Scale at Discharge

  This scale assesses tendencies towards impulsive action in response to positive emotion. The scale ranges from 1-4, with higher scores indicating more problems with this type of impulsivity.

  Admission and at study completion (day of discharge), an average of two weeks. Scores reported below are at discharge.

Secondary Outcomes (4)

• Estimated Stop-Signal Reaction Time (SSRT) on Stop-Signal Task (ms) at Discharge

  Baseline and at study completion (discharge), an average of two weeks. Scores reported below are at discharge.

• Feasibility of Assessing Change in Event-related Potentials (ERPs) During a Stop-Signal Task in a Partial Hospital Population

  Baseline and at study completion (discharge), an average of two weeks. Baseline data and discharge data are shown separately below.

• Completion Rates

  At study completion, an average of two weeks.

• Average Perceived Helpfulness of Training

  At study completion, an average of two weeks.

Study Arms (2)

Cognitive Training plus Treatment as Usual

EXPERIMENTAL

Participants in this arm will receive daily computerized cognitive training sessions during partial hospitalization, in addition to treatment as usual. Cognitive training sessions will alternate between response inhibition training and working memory training.

Other: Cognitive Control Training

Treatment as Usual (TAU)

NO INTERVENTION

Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.

Interventions

Cognitive Control Training OTHER

Cognitive Control Training involves daily practice with one of two computerized interventions. The first intervention is an adaptive Go/No-Go task to provide practice in the domain of response inhibition. Participants press a key as fast as possible in response to stimuli (letters of the alphabet), but must inhibit responses to a specific letter. The second intervention is an adaptive Paced Auditory Serial Addition Task (PASAT), designed to practice working memory. Participants are presented with single numbers presented aurally, and must add each number they hear to the previous number and click the correct sum on the screen.

Cognitive Training plus Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently receiving treatment at the McLean Hospital Behavioral Health Partial Hospital Program (PHP)
• Report an average score of 3.0 or greater on the Negative Urgency scale, the Positive Urgency scale, or 3.0 or greater on both scales, upon admission to the PHP
• Right-handed (if enrolled in EEG arm)

You may not qualify if:

• Currently undergoing electroconvulsive therapy (ECT)
• Current symptoms of acute mania
• Current symptoms of acute psychosis
• History of traumatic brain injury

Sponsors & Collaborators

• Mclean Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Related Publications (2)

• Peckham AD, Johnson SL. Cognitive control training for emotion-related impulsivity. Behav Res Ther. 2018 Jun;105:17-26. doi: 10.1016/j.brat.2018.03.009. Epub 2018 Mar 27.

  PMID: 29609103 BACKGROUND

• Peckham AD, Sandler JP, Dattolico D, McHugh RK, Johnson DS, Bjorgvinsson T, Pizzagalli DA, Beard C. Cognitive control training for urgency: A pilot randomized controlled trial in an acute clinical sample. Behav Res Ther. 2021 Nov;146:103968. doi: 10.1016/j.brat.2021.103968. Epub 2021 Sep 14.

  PMID: 34562728 DERIVED

MeSH Terms

Conditions

Impulsive Behavior; Mental Disorders; Inhibition, Psychological

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

Recruitment for this trial was terminated early, prior to reaching the target sample size, due to the recruitment site shutting down during the COVID-19 pandemic.

Results Point of Contact

• Title: Dr. Andrew Peckham
• Organization: McLean Hospital

adpeckham@mclean.harvard.edu

617-855-2946

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 17, 2018
• Study Start: September 11, 2018
• Primary Completion: March 11, 2020
• Study Completion: March 11, 2020
• Last Updated: August 20, 2021
• Results First Posted: March 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be made available when primary data analysis is complete.
• Access Criteria: Data will be made available to users of the NDCT website: https://data-archive.nimh.nih.gov/

Locations

US (1)