EEG Alpha/Theta Neurofeedback to Reduce Trait Anxiety

NCT02964520 | Completed

• 1 other identifier: PRO15070009
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates if individuals with moderate to high trait anxiety can learn how to self-regulate their brain waves and reduce their trait anxiety in ten sessions of EEG alpha-theta neurofeedback training. Half of the randomly assigned participants will receive alpha/theta neurofeedback training while the other half will receive a two-part control protocol where low beta and beta waves will be uptrained in and downtrained in in successive sessions.

Conditions

Anxiety

Keywords

trait anxiety; A/T neurofeedback; EEG biofeedback; randomized

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the State-Trait Anxiety Inventory (STAI) Scale

  Change from baseline of symptoms of anxiety to end of treatment after 4-5 weeks. The STAI scale consists of total 40 items on separate scales measuring state (20 items) and trait (20 items) anxiety. The participant reports how they feel right now at this moment for state anxiety and how they generally feel for trait anxiety. The state items are scored as: 1 (not at all), 2 (somewhat true), 3 (moderately true), 4 (very true). The trait items are scored as: 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). The total scores range from 4-80 for each scale. Higher scores indicate more anxious participants.

  1-2 weeks pre-treatment and at post treatment at end of last treatment session (4-5 weeks)

Secondary Outcomes (6)

• Theta/alpha (T/A) ratios in EEG recorded at Pz scalp location

  pre- and post each of 3 NFB segments (3 eight-minute segments per NFB session) and over the course of 10 sessions (4-5 weeks)

• 19-channel Mini-QEEG

  pre-treatment and at post treatment at end of last treatment session (4-5 weeks)

• Change from baseline in Generalized Anxiety Disorder 7-item Scale (GAD-7)

  1-2 weeks pre-treatment and at post treatment at end of last treatment session (4-5 weeks)

• Change from baseline in Beck Anxiety Inventory (BAI) Scale

  1-2 weeks pre-treatment and at post treatment at end of last treatment session (4-5 weeks)

• Change from baseline in Activation Deactivation Adjective Checklist (AD ACL)

  1-2 weeks pre-treatment and at post treatment at end of last treatment session (4-5 weeks)

Study Arms (2)

A/T Neurofeedback training

EXPERIMENTAL

10 sessions of uptraining alpha (8-11 Hz) and theta (5-7.5 Hz) frequency bands, inhibiting beta (15-30 Hz) and delta (2-4 Hz)

Behavioral: Neurofeedback training

Sham neurofeedback training

SHAM COMPARATOR

5 sessions of (sessions 1,3,5,7,9) up-training lobeta (13-16 Hz) and hibeta (16-22 Hz), inhibiting alpha (8-11 Hz), theta (5-7.5 Hz) and hibeta (23-30 Hz). 5 sessions of (sessions 2,4,6,8,10) down-training beta (13-16 Hz) and hibeta (16-22 Hz), inhibiting alpha (8-11 Hz), theta (5-7.5 Hz) and hibeta (23-30 Hz)

Behavioral: Sham comparator: Sham neurofeedback training

Interventions

Neurofeedback training BEHAVIORAL

uptraining alpha (8-11 Hz) and theta (5-7.5 Hz) frequency bands, inhibiting beta (15-30 Hz) and delta (2-4 Hz)

A/T Neurofeedback training

Sham comparator: Sham neurofeedback training BEHAVIORAL

in UNEVEN neurofeedback sessions (1,3,5,7,9): up-training lobeta (13-16 Hz) and hibeta (16-22 Hz), inhibiting alpha (8-11 Hz), theta (5-7.5 Hz) and hibeta (23-30 Hz) in EVEN neurofeedback sessions (2,4,6,8,10): down-training beta (13-16 Hz) and hibeta (16-22 Hz), inhibiting alpha (8-11 Hz), theta (5-7.5 Hz) and hibeta (23-30 Hz)

Sham neurofeedback training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults, age 18 and above
• scores of \>66% on the State Trait Anxiety Inventory (STAI)

You may not qualify if:

• scores \>19 on the Beck Depression Inventory (BDI-II)
• scores \> 9 on the Patient Health Questionnaire (PHQ-9)
• comorbid diagnoses of: Major Depression, Bipolar Disorder, Schizophrenia, Substance Use Disorder, Tic disorders, Seizure Disorders

Sponsors & Collaborators

• University of Hartford: lead

Study Sites (1)

University of Hartford

West Hartford, Connecticut, 06117, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Bettina Viereck, Dipl-Psych

  University of Hartford, Department of Psychology

  PRINCIPAL INVESTIGATOR

• Ute Strehl, Ph.D.; Dipl.-Psych.

  University of Tuebingen, Institute for Medical Psychology and Behavioural Neurobiology, Germany

  STUDY CHAIR

• Boris Kotchoubey, Ph.D.; M.D.

  University of Tuebingen, Institute for Medical Psychology and Behavioural Neurobiology, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 16, 2016
• Study Start: July 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 5, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)