NCT04912089

Brief Summary

The proposed project aims to test the cognitive and neural effects of a cognitive training in a sample of individuals seeking treatment for anxiety, depression, or traumatic stress symptoms. Participants will be randomly assigned to a high dose, low dose, or assessment only condition. Participants will be compared on cognitive performance and brain response during cognitive tasks from baseline to post-treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

October 15, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

July 23, 2025

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

1.6 years

First QC Date

May 28, 2021

Results QC Date

June 12, 2024

Last Update Submit

July 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Cognitive Performance

    Span Working Memory Score. Scores are calculated based on memory accuracy total points across all trials, with higher scores indicating better performance (0-81 range).

    Baseline, Week 4

Secondary Outcomes (16)

  • Change in Reading Span Blood Oxygen Level Dependent (BOLD) Response

    Baseline, Week 4

  • Change in Emotional Working Memory Blood Oxygen Level Dependent (BOLD) Response

    Week 4

  • Change in Neuropsychological Performance

    Baseline, Week 4

  • Anxiety Symptoms

    Baseline, Week 4

  • Symptoms of Depression

    Baseline, Week 4

  • +11 more secondary outcomes

Study Arms (3)

Cognitive Training Low Dose

EXPERIMENTAL

Cognitive training completed for 8 sessions

Behavioral: COGENT

Cognitive Training High Dose

EXPERIMENTAL

Cognitive training completed for 16 sessions

Behavioral: COGENT

Repeat Assessment

NO INTERVENTION

Interventions

COGENTBEHAVIORAL

COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.

Cognitive Training High DoseCognitive Training Low Dose

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age 21-55
  • fluent in English
  • diagnosis of mood, anxiety, or traumatic stress disorder
  • clinically elevated repetitive negative thinking
  • outpatient status
  • week stability if taking selective serotonin reuptake inhibitor (SSRI) medications

You may not qualify if:

  • past year diagnosis of severe alcohol or moderate or greater substance use disorder
  • lifetime history of psychotic or bipolar I disorder
  • acute suicidality necessitating immediate clinical intervention
  • neurodegenerative or neurodevelopmental disorders
  • history of moderate or severe traumatic brain injury or other known neurological condition
  • sensory deficits that would preclude completing tasks
  • conditions unsafe for completing MRI scanning (e.g., metal in body)
  • currently receiving psychosocial treatment
  • currently receiving psychiatric pharmacotherapy, except SSRIs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC San Diego

San Diego, California, 92037, United States

Location

MeSH Terms

Conditions

Anxiety DisordersDepressionStress Disorders, Post-Traumatic

Interventions

cogent db

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related Disorders

Results Point of Contact

Title
Jessica Bomyea
Organization
UC San Diego

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 28, 2021

First Posted

June 3, 2021

Study Start

October 15, 2021

Primary Completion

May 31, 2023

Study Completion

June 30, 2023

Last Updated

July 23, 2025

Results First Posted

July 23, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations