Attention Control Treatment for Post Traumatic Stress Disorder ׂ(PTSD)

Attention Control Treatment for Post Traumatic Stress Disorder

The purpose of this study is to explore the efficacy of Attention Control Training for Post Traumatic Stress Disorder (PTSD).

ACT was found to be effective in decreasing attention bias variability and PTSD symptoms in combat veterans (Badura-Brack, et al., 2015). It is now important to continue the examination of ACT's efficacy in additional populations of patients with PTSD. Such extension of treatment to other traumatic experiences raises the question of whether the threatening content of the training material could be personalized for each patient.

Study Overview

• Status: Completed
• Conditions: PTSD
• Intervention / Treatment: Behavioral: Personalized Attention control training (ACT); Behavioral: Non-personalized Attention control training (ACT); Behavioral: Control training.

Detailed Description

The aim of this study is to explore the efficacy of Attention Control Training for Post Traumatic Stress Disorder (PTSD).

ACT was found to be effective in decreasing attention bias variability and PTSD symptoms in combat veterans (Badura-Brack, et al., 2015). It is now important to continue the examination of ACT's efficacy in additional populations of patients with PTSD. Such extension of treatment to other traumatic experiences raises the question of whether the threatening content of the training material could be personalized for each patient.

For this purpose, we will recruit participants that are diagnosed with PTSD and will be randomly assigned to one of three conditions: personalized ACT, non-personalized ACT, or control training We expect that personalized ACT will produce greater reduction in PTSD symptoms relative to a non-personalized ACT, and that both these conditions will be more effective in symptoms reduction than a control condition not designed to affect attention or expose patients to threat stimuli. We also expect the ACT conditions to reduce attention bias variability relative to the control condition.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 69978
    • Tel Aviv University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Meeting a current diagnosis of Post-Traumatic Stress Disorder (PTSD) according to DSM-V (American Psychiatric Association, 2013);

Exclusion Criteria:

1. A diagnosis of psychotic or bipolar disorders.
2. A diagnosis of a neurological disorder (i.e., epilepsy, brain injury).
3. Suicidal ideation.
4. Drugs or alcohol abuse.
5. Non-fluent Hebrew.
6. A pharmacological treatment that is not stabilized in the past 3 months (a stable treatment will not be a reason for exclusion from the study).
7. Pregnancy. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalized ACT; The personalized attention control training (ACT), comprised of six computerized sessions, in purpose of modulate biases in attention for personalized threat stimuli.	Behavioral: Personalized Attention control training (ACT); In this intervention, participants will be trained with a personalized Dot-Probe task. Each participant will perform the task with the set of words that he or she ranked as the most threatening according to a Word Ranking Task.
Active Comparator: Non personalized ACT; The Non-personalized attention control training (ACT), comprised of six sessions, in purpose of modulate biases in attention for non-personalized threat stimuli.	Behavioral: Non-personalized Attention control training (ACT); In this intervention, participants will be trained with the same Dot-Probe task as in the personalized condition, except that the word stimuli will be randomly fit for each participant. It should be noted that 25% out of the words in this condition will be high ranked words according to each patient's word ranking. The aim of this is to enhance similarity to a generic ACT intervention (see Badura-Brack et al., 2015), where there is some degree of exposure to what one may consider "personalized" stimuli (i.e., threat words that were randomly included by the researchers), although it is not deliberately set to idiosyncratic preferences.
Placebo Comparator: Control training; Computerized control training, comprised of six sessions with a variation of the dot-probe task with neutral stimuli	Behavioral: Control training.; In this intervention, participants will perform a computerized task, similar to the Dot-Probe task. In each trial, one neutral word will be presented at the center of the screen and participants will respond to a probe ('E' or 'f') presented following the removal of the words display. This version does not include the essential ingredients thought to reduce PTSD symptoms in the other dot-probe tasks: exposure to threat content and competition on attentional resources. Thus, this control version provides a control condition for the ACT interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A diagnosis of PTSD and a total score of severity symptoms, as driven from the CAPS-5 interview	The Clinician Administered PTSD Scale (CAPS-5), is a structured interview that will be used to make a diagnosis of PTSD according to the DSM-V criteria. This interview is consists of 30 items regarding the frequency and intensity of PTSD symptoms and a total score of severity is been rated (Weathers, Blake, Schnurr, Kaloupek, Marx, & Keane, 2013).	40 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total score of the PTSD Checklist (PCL-5).	The PCL-5, is a 20-item National Center for PTSD Checklist of the Department of Veterans Affairs. Scores can range from 0 to 80, with higher scores reflecting more symptoms of PTSD (Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 2013).	10 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total score of the PHQ-9	The PHQ-9 , us a 10-item scale for depression symptoms.	10 minutes
The CGI/S	Severity and improvement scales (CGI-S/I; Guy, 1976) will be used to assess participants global clinical condition. The CGI-S and the CGI-I are single-items, clinician-reported, measure assessing severity and improvement of illness using a 7-point Likert-type scale. The CGI-S/I has good inter-rater reliability and concurrent validity with other measures. This tool is widely used in clinical trials concerning psychopathology treatments and has good sensitivity to clinical change (e.g., Berk et al., 2008; Hedges, Brown, & Shwalb, 2009; Kadouri, Corruble, & Falissard, 2007; Leon et al., 1993).	5 minutes

Collaborators and Investigators

• Sponsor: Tel Aviv University
• Investigators: Principal Investigator: Yair Bar-Haim, Prof., Tel Aviv University

Publications and helpful links

General Publications

• Weathers, F., Blake, D., Schnurr, P., Kaloupek, D., Marx, B., & Keane, T., The clinician-administered PTSD scale for DSM-5 (CAPS-5). Interview available from the National Center for PTSD at www. ptsd. va. gov, 2013.
• American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders (DSM-5). American Psychiatric Pub, 2013
• 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.
• Weathers, F., B. Litz, T. Keane, P. Palmieri, B. Marx, & P. Schnurr, The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www. ptsd. va. gov, 2013.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: October 25, 2016
• First Submitted That Met QC Criteria: October 25, 2016
• First Posted (Estimate): October 26, 2016

Study Record Updates

• Last Update Posted (Actual): June 22, 2020
• Last Update Submitted That Met QC Criteria: June 19, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: PTSD; attention training; cognitive bias modification
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: TAUPTSD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No