NCT03350360

Brief Summary

Participants will complete a pre and post training psychological assessment. Participants will be assigned to attention control training or the comparison stimuli computer task in a double-blind randomized control trial design. Both computerized dot probe tasks display two stimuli on a computer screen, one above the other, followed by a small right or left arrow appearing in the location vacated by one of the stimuli. Participants are required to respond as quickly as they can by pressing the indicated right or left arrow on their computer keyboard without compromising accuracy. Participants complete 6 training sessions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

November 17, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2020

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

3 years

First QC Date

November 16, 2017

Last Update Submit

July 15, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in posttraumatic stress disorder (PTSD) symptoms from pre to post test

    Structured diagnostic interview for PTSD

    30 minute long administration at both pre and post training to measure change. (repeat assessments are conducted 1 month apart)

Study Arms (3)

Attention Control Training Clinic

EXPERIMENTAL

Attention Control Training Clinic will consist of: * 6 sessions in the clinic lasting approximately 10 minutes each. * Each session will consist of 128 presentations of pairs of neutral and threatening stimuli, followed by the presentation of a response cue (right or left arrow to be clicked on a computer keyboard).

Behavioral: Attention Control Training

Attention Control Training Web-delivery

EXPERIMENTAL

Attention Control Training Web-delivery will consist of: * 6 sessions lasting approximately 10 minutes each logged into via the internet from the participants' home. * Each session will consist of 128 presentations of pairs of neutral and threatening stimuli, followed by the presentation of a response cue (right or left arrow to be clicked on a computer keyboard). * Ideally participants will complete 2 sessions per week, allowing them to complete the trial in less than one month's time

Behavioral: Attention Control Training

Comparison Task Clinic

PLACEBO COMPARATOR

* 6 sessions in the clinic of a presumably inactive neutral-neutral stimuli intervention lasting approximately 10 minutes each. * Each session will consist of 128 presentations of pairs of faces, followed by the presentation of a response cue (right or left arrow to be clicked on a computer keyboard). (Note that those receiving this arm, are invited to repeat the attention control training web-delivery arm at the end of their participation).

Behavioral: Attention Control TrainingBehavioral: Comparison Task

Interventions

Attention control training teaches participants that the emotional salience of cues (i.e., threatening or neutral) is not related to successful completion of the computerized response task, and thus, teaches participants to ignore irrelevant threat-related contingencies (Badura-Brack et al., 2015).

Attention Control Training ClinicAttention Control Training Web-deliveryComparison Task Clinic
Comparison TaskBEHAVIORAL

Neutral- neutral stimuli prior to response task

Comparison Task Clinic

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • military veteran or woman exposed to interpersonal violence (e.g. domestic or sexual violence).
  • significant symptoms of PTSD

You may not qualify if:

  • bipolar disorder, schizophrenia, OCD, unable to attend sessions sober.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University

Omaha, Nebraska, 68178, United States

Location

Related Publications (1)

  • Badura-Brack AS, Naim R, Ryan TJ, Levy O, Abend R, Khanna MM, McDermott TJ, Pine DS, Bar-Haim Y. Effect of Attention Training on Attention Bias Variability and PTSD Symptoms: Randomized Controlled Trials in Israeli and U.S. Combat Veterans. Am J Psychiatry. 2015 Dec;172(12):1233-41. doi: 10.1176/appi.ajp.2015.14121578. Epub 2015 Jul 24.

    PMID: 26206075BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Random assignment and coded entry to a computer website
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

November 16, 2017

First Posted

November 22, 2017

Study Start

November 17, 2017

Primary Completion

November 17, 2020

Study Completion

November 17, 2020

Last Updated

July 19, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations