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Clinical Trials/NCT03350360
NCT03350360CompletedNot Applicable

Randomized Clinical Trials of Attention Control Training for PTSD Related to Combat or Interpersonal Violence

Creighton University1 site in 1 country73 target enrollmentStarted: November 17, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
73
Locations
1
Primary Endpoint
Change in posttraumatic stress disorder (PTSD) symptoms from pre to post test

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Masking Description

Random assignment and coded entry to a computer website

Eligibility Criteria

Ages
19 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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).

Intervention: Attention Control Training (Behavioral)

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

Intervention: Attention Control Training (Behavioral)

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).

Intervention: Attention Control Training (Behavioral)

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).

Intervention: Comparison Task (Behavioral)

Outcomes

Primary Outcomes

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

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

Structured diagnostic interview for PTSD

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Amy Badura Brack

Professor of Psychology

Creighton University

Study Sites (1)

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