Neurotherapeutics as an Adjunctive Approach to Enhance Exposure Outcomes in Anxiety

Anxiety Disorders Clinical Trial

Official title:

Neurotherapeutics as an Adjunctive Approach to Enhance Exposure Outcomes in Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04953832
• Other study ID #: 191018
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: September 1, 2021

Study information

• Verified date: September 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Behavioral:
• Cognitive Training
Participants are asked to remember a series of items while solving puzzles.

Locations

Country	Name	City	State
United States	UC San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BOLD activation during cognitive task	Working Memory Span task during fMRI	immediately after the intervention
Primary	BOLD activation during emotional task	Face processing task during fMRI	immediately after the intervention
Secondary	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