Neurotherapeutics as an Adjunctive Approach to Enhance Exposure Outcomes in Anxiety

NCT04953832 | Completed

• 1 other identifier: 191018
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety Disorders

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Speech anxiety ratings

  baseline, ratings during 3 speeches

Study Arms (2)

Cognitive Training + exposure

EXPERIMENTAL

Participants will complete adaptive computerized cognitive training plus a series of speech tasks

Behavioral: Cognitive Training

No training + exposure

ACTIVE COMPARATOR

Participants will complete a low-dose computerized cognitive program plus a series of speech tasks

Behavioral: Cognitive Training

Interventions

Cognitive Training BEHAVIORAL

Participants are asked to remember a series of items while solving puzzles.

Cognitive Training + exposure; No training + exposure

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Screened positive for anxiety symptoms
• Between the ages of 18-55, inclusive.
• 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.
• Have sufficient proficiency in English language to understand and complete interviews, questionnaires, and all other study procedures.

You may not qualify if:

• Evidence of psychosis, bipolar disorder, or severe substance use disorder based on clinical cutoffs on self report measures
• Current neurological conditions based on brief medical history
• Current psychotherapy for anxiety or psychotropic medications
• 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.
• Active suicidal ideation endorsed on the depression self-report measure.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UC San Diego

San Diego, California, 92037, United States

Location

MeSH Terms

Conditions

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: July 8, 2021
• Study Start: November 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)