Attention Control Treatment for Post Traumatic Stress Disorder ׂ(PTSD)

NCT02945709 | Completed

• 1 other identifier: TAUPTSD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PTSD

Keywords

PTSD; attention training; cognitive bias modification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Total score of the PTSD Checklist (PCL-5).

  10 minutes

Other Outcomes (2)

• Total score of the PHQ-9

  10 minutes

• The CGI/S

  5 minutes

Study Arms (3)

Personalized ACT

EXPERIMENTAL

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)

Non personalized ACT

ACTIVE COMPARATOR

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)

Control training

PLACEBO COMPARATOR

Computerized control training, comprised of six sessions with a variation of the dot-probe task with neutral stimuli

Behavioral: Control training.

Interventions

Personalized Attention control training (ACT) BEHAVIORAL

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.

Personalized ACT

Non-personalized Attention control training (ACT) BEHAVIORAL

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.

Non personalized ACT

Control training. BEHAVIORAL

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.

Control training

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• A diagnosis of psychotic or bipolar disorders.
• A diagnosis of a neurological disorder (i.e., epilepsy, brain injury).
• Suicidal ideation.
• Drugs or alcohol abuse.
• Non-fluent Hebrew.
• Pregnancy. -

Sponsors & Collaborators

• Tel Aviv University: lead

Study Sites (1)

Tel Aviv University

Tel Aviv, 69978, Israel

Location

Related Publications (4)

• 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.

  BACKGROUND

• American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders (DSM-5). American Psychiatric Pub, 2013

  BACKGROUND

• 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: 26206075 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Yair Bar-Haim, Prof.

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Yair Bar-Haim

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: October 26, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)