Attention Control Training for PTSD Related to Combat or Interpersonal Violence

NCT ID: NCT03350360

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-17
• Study Completion Date: 2020-11-17

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.

Conditions

PTSD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Attention Control Training Clinic

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).

Group Type: EXPERIMENTAL

Attention Control Training

Intervention Type: BEHAVIORAL

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 Web-delivery

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

Group Type: EXPERIMENTAL

Attention Control Training

Intervention Type: BEHAVIORAL

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).

Comparison Task Clinic

• 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).

Group Type: PLACEBO_COMPARATOR

Attention Control Training

Intervention Type: BEHAVIORAL

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).

Comparison Task

Intervention Type: BEHAVIORAL

Neutral- neutral stimuli prior to response task

Interventions

Attention Control Training

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).

Intervention Type: BEHAVIORAL

Comparison Task

Neutral- neutral stimuli prior to response task

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Creighton University

OTHER

Sponsor Role: lead

Responsible Party

Amy Badura Brack

Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Creighton University

Omaha, Nebraska, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 26206075 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1123259

Identifier Type: -

Identifier Source: org_study_id