Neurotherapeutics as an Adjunctive Approach to Enhance Exposure Outcomes in Anxiety

• Sponsor: University of California, San Diego (Other)
• Overall Status: Completed
• CT.gov ID: NCT04953832
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 22
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorders	Behavioral: Cognitive Training	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Neurotherapeutics as an Adjunctive Approach to Enhance Exposure Outcomes in Anxiety
• Actual Study Start Date: Nov 1, 2019
• Actual Primary Completion Date: Sep 1, 2021
• Actual Study Completion Date: Sep 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. BOLD activation during cognitive task [immediately after the intervention]

   Working Memory Span task during fMRI

2. BOLD activation during emotional task [immediately after the intervention]

   Face processing task during fMRI

Secondary Outcome Measures

1. Speech anxiety ratings [baseline, ratings during 3 speeches]

   Subjective units of distress, scaled from 0 to 100, during each of 3, 7-minute speech activities

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC San Diego	San Diego	California	United States	92037

Sponsors and Collaborators

• University of California, San Diego

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jessica Bomyea, Assistant Professor, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT04953832
• Other Study ID Numbers: 191018
• First Posted: Jul 8, 2021
• Last Update Posted: Oct 1, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of Oct 1, 2021