Computerized Cognitive Training in Middle-Aged Adults With Generalized Anxiety Disorder: A Pilot Study

NCT04421690 | Completed

• 1 other identifier: 2021943
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to look at the effects of computerized cognitive training on anxiety, sleep, mental abilities (cognition), and other aspects of daytime functioning, such as arousal.

Conditions

Generalized Anxiety Disorder

Keywords

Anxiety; Middle-Aged; Sleep; Cognition; Older Adults

Outcome Measures

Primary Outcomes (6)

• Objective Cognition - Computerized Cognitive Tasks

  Complete computerized tasks. These tasks will measure cognitive functions (e.g., processing speed).

  Up to 10 weeks

• Objective Cognition - Computerized Cognitive Tasks

  Complete computerized tasks. These tasks will measure cognitive functions (e.g., attention).

  Up to 10 weeks

• Objective Cognition - Computerized Cognitive Tasks

  Complete computerized tasks. These tasks will measure cognitive functions (e.g., executive function).

  Up to 10 weeks

• Subjective Cognitive Self-Efficacy. -Cognitive Failures Questionnaire

  A 25-item questionnaire. Participants rate from 0 (never) to 4 (very often) frequency of cognitive errors. Higher scores indicate lower cognitive self-efficacy.

  Up to 10 weeks

• Coronavirus Anxiety Scale

  5- item questionnaire that assess anxiety related to the Coronavirus.

  Up to 10 weeks

• Anxiety - State-Trait Anxiety Inventory

  Inventory that asks respondents to rate how true 20 self-descriptive statements (e.g., I feel calm) are on a 4-point scale (1 = not at all, 4 = very much so). Typically, respondents are asked to rate statements according to how they generally feel (trait-anxiety scale) and how they feel in the current moment (state-anxiety scale). Total scores range from 20 to 80, with higher scores indicating greater maladjustment.

  Up to 10 weeks

Secondary Outcomes (20)

• Game-related experience- Sessions and duration played

  Up to 10 weeks

• Circadian Rhythm- Morningness-Eveningness Questionnaire

  Up to 10 weeks

• Subjective Arousal- Global Cognitive Arousal-Perceived Stress Scale

  Up to 10 weeks

• Subjective Arousal- Pre-sleep Arousal Scale

  Up to 10 weeks

• Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale

  Up to 10 weeks

Study Arms (2)

Cognitive Training

EXPERIMENTAL

8 week computerized cognitive training

Behavioral: Cognitive Training

Trivia Training

ACTIVE COMPARATOR

8 week computerized trivia training

Behavioral: Trivia Training

Interventions

Cognitive Training BEHAVIORAL

Participants (n=15) will complete computerized cognitive training games and activities online 3 times/week for 8 weeks.

Cognitive Training

Trivia Training BEHAVIORAL

Participants (n=15) will receive computerized trivia questions to answer and submit 3 times/week for 8 weeks.

Trivia Training

Eligibility Criteria

• Age: 45 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• yrs of age
• no neurological or psychiatric illness, dementia, or loss of consciousness \> 5 mins
• nongamers (i.e., report \<1 hour of video/cognitive training games/week over last 2 yrs)
• proficient in English (reading and writing)
• computer meets technology requirements (i.e. Windows: Windows 7 or above using Internet Explorer 11 or Edge, Mozilla Firefox 41 and above, Google Chrome 48 and above; Mac OS: Mac OS X v10.8 and above using Safari 10 and above, Mozilla Firefox 42 and above, Google Chrome 48 and above; Android App: Android 6 or higher version; iOS App: iOS 10 or higher version
• meet clinical dx criteria for Generalized Anxiety Disorder.

You may not qualify if:

• unable to provide informed consent
• unable to undergo randomization
• Telephone Interview for Cognitive Status-modified (TICS) score \<33, 2)
• other sleep disorder (i.e., sleep apnea, Periodic Limb Movement Disorder-PLMD, narcolepsy, REM Sleep Behavior Disorder)
• severe untreated psychiatric comorbidity that renders randomization unethical
• psychotropic, anxiolytic medications or other medications(e.g., beta-blockers) that alter mood or sleep
• uncorrected visual/auditory impairments
• participation in nonpharmacological treatment for sleep/fatigue/mood outside the current study.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65201, United States

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ashley Curtis, PhD

  University of Missouri- School of Medicine

  PRINCIPAL INVESTIGATOR

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

Model Details: Participants will be randomly assigned to cognitive training or trivia training and will complete measures of anxiety, sleep, cognition (objective, self-efficacy), and self-reported arousal at baseline, and post-intervention

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 9, 2020
• Study Start: June 8, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: March 15, 2023

Record last verified: 2023-03

Locations

US (1)