Neurotherapeutics as an Adjunctive Approach to Enhance Exposure Outcomes in Anxiety

NCT ID: NCT04953832

Last Updated: 2021-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2021-09-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Cognitive Training + exposure

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

Group Type: EXPERIMENTAL

Cognitive Training

Intervention Type: BEHAVIORAL

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

No training + exposure

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

Group Type: ACTIVE_COMPARATOR

Cognitive Training

Intervention Type: BEHAVIORAL

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

Interventions

Cognitive Training

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Jessica Bomyea

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UC San Diego

San Diego, California, United States

Countries

United States

Other Identifiers

191018

Identifier Type: -

Identifier Source: org_study_id