Neurotherapeutics as an Adjunctive Approach to Enhance Exposure Outcomes in Anxiety

Anxiety disorders are highly prevalent and costly to the individual and society. Exposure-based cognitive behavioral therapy (CBT) is the gold-standard intervention for anxiety disorders, although this approach does not fully reduce symptoms for all individuals. Therefore there is a need for innovative intervention approaches. One approach to augment and improve existing therapies would be to enhance the neurocognitive basis of fear extinction processes, which are the model on which treatments are based. Enhancing these processes may be possible through computerized cognitive training techniques which target executive functioning, the cognitive processes that help people manage complex cognitive activities. The proposed project is a proof-of-concept pilot study investigating the potential for training of executive functioning to improve anxiety-related outcomes. Individuals with elevated levels of social anxiety will be randomized to single-session COGnitive Enhancement Training (COGENT) or sham training program (ST). All participants will complete a single speech session where they present three 7-minute impromptu speeches and rate their anxiety at specific intervals. Participants will then complete the COGENT paradigm and affective processing task while undergoing fMRI.

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders
• Intervention / Treatment: Behavioral: Cognitive Training

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92037
      • UC San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Screened positive for anxiety symptoms
2. Between the ages of 18-55, inclusive.
3. Have signed informed consent document(s) indicating that he/she understands the purpose of and procedures required for the study and is willing to participate in the study.
4. Have sufficient proficiency in English language to understand and complete interviews, questionnaires, and all other study procedures.

Exclusion Criteria:

1. Evidence of psychosis, bipolar disorder, or severe substance use disorder based on clinical cutoffs on self report measures
2. Current neurological conditions based on brief medical history
3. Current psychotherapy for anxiety or psychotropic medications
4. MRI contraindications including: cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (TENS unit), persons who have ever been a metal worker/welder, history of eye surgery/eyes washed out because of metal, vision problems uncorrectable with lenses, inability to lie still on one's back for 60 minutes; prior neurosurgery; tattoos with metal dyes, unwillingness to remove body piercings, and pregnancy.
5. Active suicidal ideation endorsed on the depression self-report measure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Training + exposure; Participants will complete adaptive computerized cognitive training plus a series of speech tasks	Behavioral: Cognitive Training; Participants are asked to remember a series of items while solving puzzles.
Active Comparator: No training + exposure; Participants will complete a low-dose computerized cognitive program plus a series of speech tasks	Behavioral: Cognitive Training; Participants are asked to remember a series of items while solving puzzles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BOLD activation during cognitive task	Working Memory Span task during fMRI	immediately after the intervention
BOLD activation during emotional task	Face processing task during fMRI	immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech anxiety ratings	Subjective units of distress, scaled from 0 to 100, during each of 3, 7-minute speech activities	baseline, ratings during 3 speeches

Collaborators and Investigators

• Sponsor: University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: June 28, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 30, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 191018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No