Neurotherapeutics as an Adjunctive Approach to Enhance Exposure Outcomes in Anxiety
- Conditions
- Anxiety Disorders
- Interventions
- Behavioral: Cognitive Training
- Registration Number
- NCT04953832
- Lead Sponsor
- University of California, San Diego
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description No training + exposure Cognitive Training Participants will complete a low-dose computerized cognitive program plus a series of speech tasks Cognitive Training + exposure Cognitive Training Participants will complete adaptive computerized cognitive training plus a series of speech tasks
- Primary Outcome Measures
Name Time Method BOLD activation during cognitive task immediately after the intervention Working Memory Span task during fMRI
BOLD activation during emotional task immediately after the intervention Face processing task during fMRI
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
UC San Diego
🇺🇸San Diego, California, United States