Back to resultsNeurotherapeutics as an Adjunctive Approach to Enhance Exposure Outcomes in Anxiety
Primary Purpose
Anxiety Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Training
Sponsored by
About this trial
This is an interventional basic science trial for Anxiety Disorders
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- UC San Diego
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive Training + exposure
No training + exposure
Arm Description
Participants will complete adaptive computerized cognitive training plus a series of speech tasks
Participants will complete a low-dose computerized cognitive program plus a series of speech tasks
Outcomes
Primary Outcome Measures
BOLD activation during cognitive task
Working Memory Span task during fMRI
BOLD activation during emotional task
Face processing task during fMRI
Secondary Outcome Measures
Speech anxiety ratings
Subjective units of distress, scaled from 0 to 100, during each of 3, 7-minute speech activities
Full Information
NCT ID
NCT04953832
First Posted
June 21, 2021
Last Updated
September 30, 2021
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT04953832
Brief Title
Neurotherapeutics as an Adjunctive Approach to Enhance Exposure Outcomes in Anxiety
Official Title
Neurotherapeutics as an Adjunctive Approach to Enhance Exposure Outcomes in Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Training + exposure
Arm Type
Experimental
Arm Description
Participants will complete adaptive computerized cognitive training plus a series of speech tasks
Arm Title
No training + exposure
Arm Type
Active Comparator
Arm Description
Participants will complete a low-dose computerized cognitive program plus a series of speech tasks
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training
Intervention Description
Participants are asked to remember a series of items while solving puzzles.
Primary Outcome Measure Information:
Title
BOLD activation during cognitive task
Description
Working Memory Span task during fMRI
Time Frame
immediately after the intervention
Title
BOLD activation during emotional task
Description
Face processing task during fMRI
Time Frame
immediately after the intervention
Secondary Outcome Measure Information:
Title
Speech anxiety ratings
Description
Subjective units of distress, scaled from 0 to 100, during each of 3, 7-minute speech activities
Time Frame
baseline, ratings during 3 speeches
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
UC San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neurotherapeutics as an Adjunctive Approach to Enhance Exposure Outcomes in Anxiety
We'll reach out to this number within 24 hrs